<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674335</url>
  </required_header>
  <id_info>
    <org_study_id>PACING-2012</org_study_id>
    <nct_id>NCT01674335</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Operant Learning Versus Energy Conservation Activity Pacing Treatments in Fibromyalgia</brief_title>
  <official_title>Operant Learning Versus Energy Conservation Activity Pacing Interventions in a Sample of Fibromyalgia Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people&#xD;
      with pain try to continue their daily activities at the same level as they were able to&#xD;
      manage before they had pain. This way of coping causes increases in their pain; they become&#xD;
      discouraged and give up on their activities. AP treatments involve helping them regulate&#xD;
      their activity level so that they can achieve important life goals. Although AP is widely&#xD;
      used, its effectiveness is still unproven. There are two key approaches: The operant learning&#xD;
      (OL) approach uses quotas related to time or goals the person sets. The energy conservation&#xD;
      (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have&#xD;
      often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We&#xD;
      will examine the effects of these treatments on pain, fatigue, quality of life, physical&#xD;
      functioning and mental well-being. We will also investigate whether other factors influence&#xD;
      treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS&#xD;
      patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be&#xD;
      collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS&#xD;
      patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care&#xD;
      London. OL and EC treatment manuals will be developed by experts in the field and both&#xD;
      interventions will be given by two occupational therapists over a 3 month period as&#xD;
      &quot;stand-alone&quot; interventions (10 sessions of 120 min). All sessions will be recorded in order&#xD;
      to assess intervention fidelity. This study will be the first to base AP interventions on a&#xD;
      clearly delineated theoretical framework. It will clarify whether AP strategies benefit&#xD;
      individuals with FMS and whether either of these two approaches is more effective. Our&#xD;
      results will help to direct clinical resources and funding toward the most beneficial&#xD;
      interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rational:&#xD;
&#xD;
      Activity pacing (AP) can be defined as &quot;the regulation of activity level and/or rate in the&#xD;
      service of a goal or goals&quot; (Nielson, Jensen et Vlaeyen, 2012). This general coping strategy&#xD;
      is widely used in chronic pain (CP) management both as a stand-alone treatment and as a&#xD;
      component of multimodal treatment programs. However its potential benefits remain unproven;&#xD;
      in fact, there is evidence that in some contexts, pacing may be a maladaptive coping response&#xD;
      (Gill et Brown, 2009). Thus, more knowledge regarding the effects of this coping strategy is&#xD;
      needed in order to determine if (and for whom) it is an effective pain management treatment.&#xD;
&#xD;
      Two models of AP are currently in widespread use. The Operant Learning (OL) approach uses&#xD;
      positively reinforced activity quotas that are time and/or goal contingent, rather than&#xD;
      pain-contingent, and these are gradually increased using &quot;activity-rest&quot; cycling (Fordyce,&#xD;
      1976). In contrast, the Energy Conservation (EC) approach focuses on patient energy&#xD;
      expenditure, and seeks to achieve a balance between accomplishing important day-to-day&#xD;
      activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004). Despite&#xD;
      the ubiquitous use of these two forms of AP in clinical settings, little is known about&#xD;
      either their individual or relative efficacy. Similarly, each approach involves multiple&#xD;
      elements, and it is unclear which of these elements might be responsible for putative&#xD;
      treatment effects. Two recent studies (Murphy et al., 2011 ; van Koulil et al., 2010) have&#xD;
      provided some data regarding AP, but described somewhat contradictory results and did not&#xD;
      provide clear theoretical bases for their interventions. Future research concerning the&#xD;
      effectiveness of AP should: (a) define the contents of interventions based on theory; (b)&#xD;
      avoid confounding AP with non-AP treatment elements; (c) examine the relative efficacy of&#xD;
      these two theoretically different AP methodologies; and (d) identify the clinical populations&#xD;
      that are most likely to benefit from AP treatment.&#xD;
&#xD;
      Fibromyalgia Syndrome (FMS) is a condition with a general population prevalence of&#xD;
      approximately 3-5% and is estimated to have one of the highest psychosocial and financial&#xD;
      impacts of all rheumatic diseases and chronic pain conditions. The predominant symptoms of&#xD;
      FMS are chronic widespread pain and fatigue. Although there are no disease-modifying&#xD;
      treatments available for this condition, Cognitive Behavioural and Multidisciplinary&#xD;
      Treatment Programs, usually including some form of AP, are evidence-based and widely&#xD;
      recommended. Because FMS is common, causes considerable suffering (personal, social and&#xD;
      economic) and has been the frequent target of AP methods, it is particularly important to&#xD;
      understand the efficacy of AP - both alone and as a part of multimodal treatment packages.&#xD;
      However, before this step is taken, it is important to assess the efficacy of AP as a&#xD;
      stand-alone treatment.&#xD;
&#xD;
      Research objectives:&#xD;
&#xD;
        -  To examine the effectiveness and relative benefits of OL and EC interventions on pain&#xD;
           and fatigue and to assess their impact on physical functioning, mental well-being and&#xD;
           quality of life in patients with FMS.&#xD;
&#xD;
        -  To investigate factors that are hypothesized to influence AP treatment effectiveness,&#xD;
           including use of general coping strategies and beliefs/attitudes toward pain.&#xD;
&#xD;
        -  To Examine the AP treatment with regard to the participant global impression of change&#xD;
           after the group sessions and at follow-ups.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The present study has been designed according to the CONSORT (Consolidated Standards of&#xD;
      Reporting Trials) statement. A total of 120 participants with FMS will be randomly assigned&#xD;
      to one of four intervention groups (OL, EC, delayed-OL and delayed-EC). The delayed groups&#xD;
      will receive the AP intervention 3 months later and will serve as a Usual Care control group.&#xD;
      All groups will continue to receive any concomitant interventions that they are receiving&#xD;
      (pharmacological and non-pharmacological) at the time of enrollment. Data will be collected&#xD;
      at pretreatment assessment (T0,) at the end of the intervention group (3 months, T1), at 3&#xD;
      months (T2) and 6 months (T3) booster sessions and at 12 months (T4) follow-up. In order to&#xD;
      obtain a heterogeneous sample that will be more representative of the regional FMS&#xD;
      population, participants will be recruited from different sources including health&#xD;
      professionals from primary and tertiary care settings, FMS associations and support groups&#xD;
      and direct solicitation from the community (e.g., newspapers, posters). Patients will be&#xD;
      invited to call the AP research phone line if they are interested in participating in the&#xD;
      study. If they accept and provide their written informed consent, they will be randomly&#xD;
      assigned to one of the two study conditions (delayed or not delayed). Men (only around 5% of&#xD;
      FMS population) will be randomized separately in order to insure that similar proportions of&#xD;
      each sex are included in each of our four study groups. All participants will be blinded as&#xD;
      to the nature of the research questions involved in this study.&#xD;
&#xD;
      Sample size calculation: This sample size was determined based on a standard effect size&#xD;
      calculation (Machin et Fayers, 2010) using effect size estimates obtained from previous,&#xD;
      related, studies of interventions for FMS (Murphy et al., 2011 ; van Koulil et al., 2010) and&#xD;
      takes into account an attrition rate of 20%. This calculation resulted in an estimate of 60&#xD;
      participants per group (OL, EC). Specifically, we based our estimate on data obtained from&#xD;
      FMS patients referred to the Rheumatology Day Program at St. Joseph Health Care as they are&#xD;
      representative of the population from which the sample will be recruited for our study. FMS&#xD;
      patients' referred to the program reported an average pain of 7.11 out of 10 on a numerical&#xD;
      rating scale within each subject group was normally distributed with a standard deviation of&#xD;
      1.41. We are planning to use two primary outcome measures (0-10 numerical rating scale for&#xD;
      each of pain and fatigue). Because between-group differences in non-pharmacological trials&#xD;
      are small, we chose a between-group difference of 1 on these NRS measures as our estimate. If&#xD;
      the true difference in the OL and EC means is 1, we will need a total of 51 participants' per&#xD;
      group to be able to show that one treatment is more effective than the other with power (1-β)&#xD;
      0.9. The Type I error probability associated with this test α/2 (corrected as we have 2&#xD;
      primary outcomes: pain and fatigue) is 0.025. We estimated that we will require 20.4&#xD;
      additional participants (20%) to adjust for study attrition, resulting in a total of 120&#xD;
      participants.&#xD;
&#xD;
      Interventions: OL and EC treatment manuals will be developed by two experienced clinical&#xD;
      psychologists and two occupational therapists. They will be based on the theoretical&#xD;
      underpinnings of each of the two principal AP interventions. An expert panel of 6 select&#xD;
      researchers with extensive experience in this particular field will revise and rate the&#xD;
      manual contents accordingly to Nielson et al. (Nielson, Jensen et Vlaeyen, 2012)review paper&#xD;
      about activity pacing concepts in chronic pain. This will ensure that the contents of the&#xD;
      treatment manuals are consistent with the conceptual models underlying both the OL and EC&#xD;
      interventions. These treatments will be applied as 3 month &quot;stand-alone&quot; interventions that&#xD;
      will include 10 sessions, each of 120 min duration (1-weekly for 2 months, and 2 every two&#xD;
      weeks for 1 month). Booster sessions will also be conducted at 3, 6 and 12 months follow-up.&#xD;
      Both interventions will be administered by two well-trained occupational therapists (OTs),&#xD;
      who have extensive clinical experience in treating individuals with FMS. All treatment&#xD;
      sessions will be audio-recorded. Thirty percent of all recorded sessions will then be&#xD;
      randomly selected and reviewed by two blinded assessors (using a criterion for inter-rater&#xD;
      reliability, Cohen's κ, of &gt; .80) in order to evaluate: 1) therapeutic alliance (7-points&#xD;
      Likert scale), and 2) treatment fidelity (therapist adherence to the treatment manual)&#xD;
      (7-point Likert scale).&#xD;
&#xD;
      Questionnaires and assessment tools: Questionnaires and measurement tools has been chosen&#xD;
      according to IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical&#xD;
      Trials) and OMERACT (Outcome Measures in Rheumatology Clinical Trials) recommendations.&#xD;
      Socio-demographic data and information about concurrent treatments will be collected only at&#xD;
      baseline while participant's global impression of change will only be measured at follow-ups.&#xD;
      All others questionnaires will be completed at baseline (T0), after the intervention (T1) and&#xD;
      at booster sessions (T2, T3, T4). Delayed intervention groups will complete T0 once and at 3&#xD;
      months baseline before starting the intervention.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      A split-plot factorial design will serve as the basis for this study. A first set of analyses&#xD;
      (t-tests, chi-squares) will be performed to evaluate possible baseline differences between&#xD;
      OL, EC and the Delayed groups on the outcome and/or demographic measures. Depending on the&#xD;
      results of these analyses, a repeated measures (T1,T2, T3, T4) ANOVA (or ANCOVA if there are&#xD;
      significant between-group differences on baseline measures, e.g. baseline pain) will be&#xD;
      conducted to compare the three study groups on the primary outcome measures. Similarly,&#xD;
      repeated measures ANOVAs (and/or ANCOVAs) will be used to evaluate the secondary and tertiary&#xD;
      outcomes measures. Post-hoc multiple comparisons will then be conducted to evaluate simple&#xD;
      and simple-simple effects, correcting for the number of comparisons. Secondary objectives&#xD;
      will be evaluated using multiple regression analyses examining the relationship between&#xD;
      treatment change and each of the proposed predictor variables.&#xD;
&#xD;
      Contributions:&#xD;
&#xD;
      The proposed study will be an important first step in both evaluating the efficacy of the two&#xD;
      commonly used AP strategies and understanding their relationship with other variables that&#xD;
      influence treatment outcome. This study will also be the first to base AP interventions on a&#xD;
      clearly delineated theoretical framework. Assuming that one or both forms of AP show a&#xD;
      beneficial effect on treatment outcomes, subsequent research will be able to further refine&#xD;
      the contents of AP interventions. The results will also clarify the appropriateness of using&#xD;
      AP strategies for individuals with FMS and will provide information as to which (or both) of&#xD;
      the two approaches provide clinical benefit. Finally, this research also has important&#xD;
      implications for health care resource allocation and expenditures. From the perspective of&#xD;
      evidence-based practice, clinical resources and funding can be directed toward what are&#xD;
      identified as the most beneficial interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in pain will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in fatigue will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Socio-demographic questionnaire</measure>
    <time_frame>Pretreatment (T0).</time_frame>
    <description>Information on sex, age, ethnicity, civil status, education, work status, income, will be collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>Questionnaire measuring pain interference in different life aspects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Fatigue Inventory</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>Questionnaire measuring fatigue interference in different life aspects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF36v2 Health Survey</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>Questionnaire measuring quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study (MOS) - Sleep scale</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
    <description>Questionnaire measuring sleep problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structured Assessment</measure>
    <time_frame>Pretreatment (T0)</time_frame>
    <description>Information on current medications and health care utilization, fibromyalgia characteristics (symptoms, duration etc.), chronic pain and fatigue family history as well as comorbid mental and physical condition.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Coping Strategies Questionnaire (CSQ) (Short-Form 2 items)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Multidimensional Pain Readiness to Change Questionnaire (MPRCQ2) - Pacing scale</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Survey of Pain Attitudes (SOPA) (Short-Form 2 items)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patterns of Activity - Pain (POAM-P)</measure>
    <time_frame>Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patients' Global Impression of Change (PGIC)</measure>
    <time_frame>PretreatmentPost-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Delayed-Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A total of 120 participants with fibromyalgia will be randomly assigned to one of four intervention groups (Operant Learning (OL), Energy Conservation (EC), delayed-OL and delayed-EC). The delayed groups will receive the AP intervention 3 months later and will serve as a Usual Care control group. All groups will continue to receive any concomitant interventions that they are receiving (pharmacological and non-pharmacological) at the time of enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operant Learning</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Energy Conservation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Operant Learning</intervention_name>
    <description>The present therapist manual focuses on the operant learning approach, which emphasizes the use of positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, using a gradually increased &quot;activity-rest&quot; cycling approach (Fordyce, 1976).&#xD;
This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.</description>
    <arm_group_label>Operant Learning</arm_group_label>
    <other_name>Activity pacing</other_name>
    <other_name>Grade activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Energy Conservation</intervention_name>
    <description>The present therapist manual focuses on the energy conservation approach, which emphasizes management of participant energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004).&#xD;
This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.</description>
    <arm_group_label>Energy Conservation</arm_group_label>
    <other_name>Activity pacing</other_name>
    <other_name>Energy envelope</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or over&#xD;
&#xD;
          -  Presenting a formal diagnosis of FMS meeting either the American College of&#xD;
             Rheumatology 1990 criteria or the 2010 clinical diagnostic criteria&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able to read, understand and answer questionnaires in English&#xD;
&#xD;
          -  Available for follow-up booster sessions during a 12 months period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have previously participated in a formal activity pacing intervention&#xD;
&#xD;
          -  Present psychological comorbidity that might interfere with the activity pacing group&#xD;
             sessions&#xD;
&#xD;
          -  Present cognitive impairment that would prevent benefiting from the activity pacing&#xD;
             group sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Warren Nielson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institue and St. Joseph's Health Care London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mélanie Racine, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute and St. Joseph's Health Care London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Health Care London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
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    <PMID>8080219</PMID>
  </reference>
  <reference>
    <citation>Fordyce WE. Behavioural methods for chronic pain and illness. St.Louis: Mosby, 1976.</citation>
  </reference>
  <reference>
    <citation>Gill JR, Brown CA. A structured review of the evidence for pacing as a chronic pain intervention. Eur J Pain. 2009 Feb;13(2):214-6. doi: 10.1016/j.ejpain.2008.03.011. Epub 2008 Apr 29.</citation>
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  </reference>
  <reference>
    <citation>Hammond A. What is the role of the occupational therapist? Best Pract Res Clin Rheumatol. 2004 Aug;18(4):491-505. doi: 10.1016/j.berh.2004.04.001.</citation>
    <PMID>15301983</PMID>
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  <reference>
    <citation>Jensen MP, Chodroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology. 2007 Apr 10;68(15):1178-82. doi: 10.1212/01.wnl.0000259085.61898.9e.</citation>
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    <citation>Jensen, M. P., et P. Karoly. 2001. &quot;Self-report scales and procedures for assessing pain in adults&quot;. In Handbook of pain assessment, D. C. Turk et R. Melzack, p. 15-34. New York: Guilford Press.</citation>
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    <citation>Jensen MP, Keefe FJ, Lefebvre JC, Romano JM, Turner JA. One- and two-item measures of pain beliefs and coping strategies. Pain. 2003 Aug;104(3):453-469. doi: 10.1016/S0304-3959(03)00076-9.</citation>
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    <PMID>7936708</PMID>
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  <reference>
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    <PMID>21810253</PMID>
  </reference>
  <reference>
    <citation>Machin, D., et P.M Fayers. 2010. &quot;Trial Size&quot;. In Randomized clinical trials: design, practice and reporting, D. Machin et P.M. Fayers: Wiley-Blackwell.</citation>
  </reference>
  <reference>
    <citation>Nielson WR, Jensen MP, Karsdorp PA, Vlaeyen JW. Activity pacing in chronic pain: concepts, evidence, and future directions. Clin J Pain. 2013 May;29(5):461-8. doi: 10.1097/AJP.0b013e3182608561.</citation>
    <PMID>23247005</PMID>
  </reference>
  <reference>
    <citation>Rosenstiel AK, Keefe FJ. The use of coping strategies in chronic low back pain patients: relationship to patient characteristics and current adjustment. Pain. 1983 Sep;17(1):33-44. doi: 10.1016/0304-3959(83)90125-2.</citation>
    <PMID>6226916</PMID>
  </reference>
  <reference>
    <citation>Smith BH, Torrance N, Bennett MI, Lee AJ. Health and quality of life associated with chronic pain of predominantly neuropathic origin in the community. Clin J Pain. 2007 Feb;23(2):143-9. doi: 10.1097/01.ajp.0000210956.31997.89.</citation>
    <PMID>17237663</PMID>
  </reference>
  <reference>
    <citation>Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.</citation>
    <PMID>16618472</PMID>
  </reference>
  <reference>
    <citation>van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders R, de Jong AJ, Haverman JF, Korff KJ, van Riel PL, Cats HA, Evers AW. Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1377-85. doi: 10.1002/acr.20268.</citation>
    <PMID>20521308</PMID>
  </reference>
  <reference>
    <citation>Ware, J. E., Jr., M. Kosinski et J. E. Dewy (2001). How to Score Version 2 of the SF-36 Health Survey (Standard and Acute Forms), Lincoln, RI: QualityMetric Incorporated</citation>
  </reference>
  <reference>
    <citation>Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.</citation>
    <PMID>20461783</PMID>
  </reference>
  <reference>
    <citation>Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.</citation>
    <PMID>2306288</PMID>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Warren Nielson, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Chronic fatigue</keyword>
  <keyword>Activity pacing</keyword>
  <keyword>Operant learning</keyword>
  <keyword>Energy conservation</keyword>
  <keyword>Treatment</keyword>
  <keyword>Intervention</keyword>
  <keyword>Biopsychosocial factors</keyword>
  <keyword>Coping</keyword>
  <keyword>Mood</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674335
org study id: PACING-2012
nct id: NCT01674335
lead sponsor: 
has dmc: No
Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people
      with pain try to continue their daily activities at the same level as they were able to
      manage before they had pain. This way of coping causes increases in their pain; they become
      discouraged and give up on their activities. AP treatments involve helping them regulate
      their activity level so that they can achieve important life goals. Although AP is widely
      used, its effectiveness is still unproven. There are two key approaches: The operant learning
      (OL) approach uses quotas related to time or goals the person sets. The energy conservation
      (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have
      often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We
      will examine the effects of these treatments on pain, fatigue, quality of life, physical
      functioning and mental well-being. We will also investigate whether other factors influence
      treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS
      patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be
      collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS
      patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care
      London. OL and EC treatment manuals will be developed by experts in the field and both
      interventions will be given by two occupational therapists over a 3 month period as
      "stand-alone" interventions (10 sessions of 120 min). All sessions will be recorded in order
      to assess intervention fidelity. This study will be the first to base AP interventions on a
      clearly delineated theoretical framework. It will clarify whether AP strategies benefit
      individuals with FMS and whether either of these two approaches is more effective. Our
      results will help to direct clinical resources and funding toward the most beneficial
      interventions.
Rational:

      Activity pacing (AP) can be defined as "the regulation of activity level and/or rate in the
      service of a goal or goals" (Nielson, Jensen et Vlaeyen, 2012). This general coping strategy
      is widely used in chronic pain (CP) management both as a stand-alone treatment and as a
      component of multimodal treatment programs. However its potential benefits remain unproven;
      in fact, there is evidence that in some contexts, pacing may be a maladaptive coping response
      (Gill et Brown, 2009). Thus, more knowledge regarding the effects of this coping strategy is
      needed in order to determine if (and for whom) it is an effective pain management treatment.

      Two models of AP are currently in widespread use. The Operant Learning (OL) approach uses
      positively reinforced activity quotas that are time and/or goal contingent, rather than
      pain-contingent, and these are gradually increased using "activity-rest" cycling (Fordyce,
      1976). In contrast, the Energy Conservation (EC) approach focuses on patient energy
      expenditure, and seeks to achieve a balance between accomplishing important day-to-day
      activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004). Despite
      the ubiquitous use of these two forms of AP in clinical settings, little is known about
      either their individual or relative efficacy. Similarly, each approach involves multiple
      elements, and it is unclear which of these elements might be responsible for putative
      treatment effects. Two recent studies (Murphy et al., 2011 ; van Koulil et al., 2010) have
      provided some data regarding AP, but described somewhat contradictory results and did not
      provide clear theoretical bases for their interventions. Future research concerning the
      effectiveness of AP should: (a) define the contents of interventions based on theory; (b)
      avoid confounding AP with non-AP treatment elements; (c) examine the relative efficacy of
      these two theoretically different AP methodologies; and (d) identify the clinical populations
      that are most likely to benefit from AP treatment.

      Fibromyalgia Syndrome (FMS) is a condition with a general population prevalence of
      approximately 3-5% and is estimated to have one of the highest psychosocial and financial
      impacts of all rheumatic diseases and chronic pain conditions. The predominant symptoms of
      FMS are chronic widespread pain and fatigue. Although there are no disease-modifying
      treatments available for this condition, Cognitive Behavioural and Multidisciplinary
      Treatment Programs, usually including some form of AP, are evidence-based and widely
      recommended. Because FMS is common, causes considerable suffering (personal, social and
      economic) and has been the frequent target of AP methods, it is particularly important to
      understand the efficacy of AP - both alone and as a part of multimodal treatment packages.
      However, before this step is taken, it is important to assess the efficacy of AP as a
      stand-alone treatment.

      Research objectives:

        -  To examine the effectiveness and relative benefits of OL and EC interventions on pain
           and fatigue and to assess their impact on physical functioning, mental well-being and
           quality of life in patients with FMS.

        -  To investigate factors that are hypothesized to influence AP treatment effectiveness,
           including use of general coping strategies and beliefs/attitudes toward pain.

        -  To Examine the AP treatment with regard to the participant global impression of change
           after the group sessions and at follow-ups.

      Methodology:

      The present study has been designed according to the CONSORT (Consolidated Standards of
      Reporting Trials) statement. A total of 120 participants with FMS will be randomly assigned
      to one of four intervention groups (OL, EC, delayed-OL and delayed-EC). The delayed groups
      will receive the AP intervention 3 months later and will serve as a Usual Care control group.
      All groups will continue to receive any concomitant interventions that they are receiving
      (pharmacological and non-pharmacological) at the time of enrollment. Data will be collected
      at pretreatment assessment (T0,) at the end of the intervention group (3 months, T1), at 3
      months (T2) and 6 months (T3) booster sessions and at 12 months (T4) follow-up. In order to
      obtain a heterogeneous sample that will be more representative of the regional FMS
      population, participants will be recruited from different sources including health
      professionals from primary and tertiary care settings, FMS associations and support groups
      and direct solicitation from the community (e.g., newspapers, posters). Patients will be
      invited to call the AP research phone line if they are interested in participating in the
      study. If they accept and provide their written informed consent, they will be randomly
      assigned to one of the two study conditions (delayed or not delayed). Men (only around 5% of
      FMS population) will be randomized separately in order to insure that similar proportions of
      each sex are included in each of our four study groups. All participants will be blinded as
      to the nature of the research questions involved in this study.

      Sample size calculation: This sample size was determined based on a standard effect size
      calculation (Machin et Fayers, 2010) using effect size estimates obtained from previous,
      related, studies of interventions for FMS (Murphy et al., 2011 ; van Koulil et al., 2010) and
      takes into account an attrition rate of 20%. This calculation resulted in an estimate of 60
      participants per group (OL, EC). Specifically, we based our estimate on data obtained from
      FMS patients referred to the Rheumatology Day Program at St. Joseph Health Care as they are
      representative of the population from which the sample will be recruited for our study. FMS
      patients' referred to the program reported an average pain of 7.11 out of 10 on a numerical
      rating scale within each subject group was normally distributed with a standard deviation of
      1.41. We are planning to use two primary outcome measures (0-10 numerical rating scale for
      each of pain and fatigue). Because between-group differences in non-pharmacological trials
      are small, we chose a between-group difference of 1 on these NRS measures as our estimate. If
      the true difference in the OL and EC means is 1, we will need a total of 51 participants' per
      group to be able to show that one treatment is more effective than the other with power (1-β)
      0.9. The Type I error probability associated with this test α/2 (corrected as we have 2
      primary outcomes: pain and fatigue) is 0.025. We estimated that we will require 20.4
      additional participants (20%) to adjust for study attrition, resulting in a total of 120
      participants.

      Interventions: OL and EC treatment manuals will be developed by two experienced clinical
      psychologists and two occupational therapists. They will be based on the theoretical
      underpinnings of each of the two principal AP interventions. An expert panel of 6 select
      researchers with extensive experience in this particular field will revise and rate the
      manual contents accordingly to Nielson et al. (Nielson, Jensen et Vlaeyen, 2012)review paper
      about activity pacing concepts in chronic pain. This will ensure that the contents of the
      treatment manuals are consistent with the conceptual models underlying both the OL and EC
      interventions. These treatments will be applied as 3 month "stand-alone" interventions that
      will include 10 sessions, each of 120 min duration (1-weekly for 2 months, and 2 every two
      weeks for 1 month). Booster sessions will also be conducted at 3, 6 and 12 months follow-up.
      Both interventions will be administered by two well-trained occupational therapists (OTs),
      who have extensive clinical experience in treating individuals with FMS. All treatment
      sessions will be audio-recorded. Thirty percent of all recorded sessions will then be
      randomly selected and reviewed by two blinded assessors (using a criterion for inter-rater
      reliability, Cohen's κ, of > .80) in order to evaluate: 1) therapeutic alliance (7-points
      Likert scale), and 2) treatment fidelity (therapist adherence to the treatment manual)
      (7-point Likert scale).

      Questionnaires and assessment tools: Questionnaires and measurement tools has been chosen
      according to IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical
      Trials) and OMERACT (Outcome Measures in Rheumatology Clinical Trials) recommendations.
      Socio-demographic data and information about concurrent treatments will be collected only at
      baseline while participant's global impression of change will only be measured at follow-ups.
      All others questionnaires will be completed at baseline (T0), after the intervention (T1) and
      at booster sessions (T2, T3, T4). Delayed intervention groups will complete T0 once and at 3
      months baseline before starting the intervention.

      Statistical analysis:

      A split-plot factorial design will serve as the basis for this study. A first set of analyses
      (t-tests, chi-squares) will be performed to evaluate possible baseline differences between
      OL, EC and the Delayed groups on the outcome and/or demographic measures. Depending on the
      results of these analyses, a repeated measures (T1,T2, T3, T4) ANOVA (or ANCOVA if there are
      significant between-group differences on baseline measures, e.g. baseline pain) will be
      conducted to compare the three study groups on the primary outcome measures. Similarly,
      repeated measures ANOVAs (and/or ANCOVAs) will be used to evaluate the secondary and tertiary
      outcomes measures. Post-hoc multiple comparisons will then be conducted to evaluate simple
      and simple-simple effects, correcting for the number of comparisons. Secondary objectives
      will be evaluated using multiple regression analyses examining the relationship between
      treatment change and each of the proposed predictor variables.

      Contributions:

      The proposed study will be an important first step in both evaluating the efficacy of the two
      commonly used AP strategies and understanding their relationship with other variables that
      influence treatment outcome. This study will also be the first to base AP interventions on a
      clearly delineated theoretical framework. Assuming that one or both forms of AP show a
      beneficial effect on treatment outcomes, subsequent research will be able to further refine
      the contents of AP interventions. The results will also clarify the appropriateness of using
      AP strategies for individuals with FMS and will provide information as to which (or both) of
      the two approaches provide clinical benefit. Finally, this research also has important
      implications for health care resource allocation and expenditures. From the perspective of
      evidence-based practice, clinical resources and funding can be directed toward what are
      identified as the most beneficial interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in pain will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4).
measure: Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in fatigue will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4)
measure: Socio-demographic questionnaire
time frame: Pretreatment (T0).
description: Information on sex, age, ethnicity, civil status, education, work status, income, will be collected
measure: Brief Pain Inventory
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: Questionnaire measuring pain interference in different life aspects.
measure: Brief Fatigue Inventory
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: Questionnaire measuring fatigue interference in different life aspects.
measure: SF36v2 Health Survey
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: Questionnaire measuring quality of life.
measure: Medical Outcomes Study (MOS) - Sleep scale
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
description: Questionnaire measuring sleep problems.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
measure: Structured Assessment
time frame: Pretreatment (T0)
description: Information on current medications and health care utilization, fibromyalgia characteristics (symptoms, duration etc.), chronic pain and fatigue family history as well as comorbid mental and physical condition.
measure: Coping Strategies Questionnaire (CSQ) (Short-Form 2 items)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
measure: Multidimensional Pain Readiness to Change Questionnaire (MPRCQ2) - Pacing scale
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
measure: Survey of Pain Attitudes (SOPA) (Short-Form 2 items)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
measure: Patterns of Activity - Pain (POAM-P)
time frame: Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
measure: Patients' Global Impression of Change (PGIC)
time frame: PretreatmentPost-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).
arm group label: Delayed-Intervention
arm group type: No Intervention
description: A total of 120 participants with fibromyalgia will be randomly assigned to one of four intervention groups (Operant Learning (OL), Energy Conservation (EC), delayed-OL and delayed-EC). The delayed groups will receive the AP intervention 3 months later and will serve as a Usual Care control group. All groups will continue to receive any concomitant interventions that they are receiving (pharmacological and non-pharmacological) at the time of enrollment.
arm group label: Operant Learning
arm group type: Active Comparator
arm group label: Energy Conservation
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Operant Learning
description: The present therapist manual focuses on the operant learning approach, which emphasizes the use of positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, using a gradually increased "activity-rest" cycling approach (Fordyce, 1976).
This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.
arm group label: Operant Learning
other name: Activity pacing
other name: Grade activity
intervention type: Behavioral
intervention name: Energy Conservation
description: The present therapist manual focuses on the energy conservation approach, which emphasizes management of participant energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004).
This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.
arm group label: Energy Conservation
other name: Activity pacing
other name: Energy envelope
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Warren Nielson, Ph.D.
role: Principal Investigator
affiliation: Lawson Health Research Institue and St. Joseph's Health Care London
last name: Mélanie Racine, Ph.D.
role: Principal Investigator
affiliation: Lawson Health Research Institute and St. Joseph's Health Care London
facility: 
country: Canada
citation: Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PMID: 8080219
citation: Fordyce WE. Behavioural methods for chronic pain and illness. St.Louis: Mosby, 1976.
citation: Gill JR, Brown CA. A structured review of the evidence for pacing as a chronic pain intervention. Eur J Pain. 2009 Feb;13(2):214-6. doi: 10.1016/j.ejpain.2008.03.011. Epub 2008 Apr 29.
PMID: 18448368
citation: Hammond A. What is the role of the occupational therapist? Best Pract Res Clin Rheumatol. 2004 Aug;18(4):491-505. doi: 10.1016/j.berh.2004.04.001.
PMID: 15301983
citation: Jensen MP, Chodroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology. 2007 Apr 10;68(15):1178-82. doi: 10.1212/01.wnl.0000259085.61898.9e.
PMID: 17420400
citation: Jensen, M. P., et P. Karoly. 2001. "Self-report scales and procedures for assessing pain in adults". In Handbook of pain assessment, D. C. Turk et R. Melzack, p. 15-34. New York: Guilford Press.
citation: Jensen MP, Keefe FJ, Lefebvre JC, Romano JM, Turner JA. One- and two-item measures of pain beliefs and coping strategies. Pain. 2003 Aug;104(3):453-469. doi: 10.1016/S0304-3959(03)00076-9.
PMID: 12927618
citation: Jensen MP, Turner JA, Romano JM, Lawler BK. Relationship of pain-specific beliefs to chronic pain adjustment. Pain. 1994 Jun;57(3):301-309. doi: 10.1016/0304-3959(94)90005-1.
PMID: 7936708
citation: Murphy SL, Lyden AK, Clary M, Geisser ME, Yung RL, Clauw DJ, Williams DA. Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans. BMC Musculoskelet Disord. 2011 Aug 2;12:177. doi: 10.1186/1471-2474-12-177.
PMID: 21810253
citation: Machin, D., et P.M Fayers. 2010. "Trial Size". In Randomized clinical trials: design, practice and reporting, D. Machin et P.M. Fayers: Wiley-Blackwell.
citation: Nielson WR, Jensen MP, Karsdorp PA, Vlaeyen JW. Activity pacing in chronic pain: concepts, evidence, and future directions. Clin J Pain. 2013 May;29(5):461-8. doi: 10.1097/AJP.0b013e3182608561.
PMID: 23247005
citation: Rosenstiel AK, Keefe FJ. The use of coping strategies in chronic low back pain patients: relationship to patient characteristics and current adjustment. Pain. 1983 Sep;17(1):33-44. doi: 10.1016/0304-3959(83)90125-2.
PMID: 6226916
citation: Smith BH, Torrance N, Bennett MI, Lee AJ. Health and quality of life associated with chronic pain of predominantly neuropathic origin in the community. Clin J Pain. 2007 Feb;23(2):143-9. doi: 10.1097/01.ajp.0000210956.31997.89.
PMID: 17237663
citation: Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.
PMID: 16618472
citation: van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders R, de Jong AJ, Haverman JF, Korff KJ, van Riel PL, Cats HA, Evers AW. Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1377-85. doi: 10.1002/acr.20268.
PMID: 20521308
citation: Ware, J. E., Jr., M. Kosinski et J. E. Dewy (2001). How to Score Version 2 of the SF-36 Health Survey (Standard and Acute Forms), Lincoln, RI: QualityMetric Incorporated
citation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PMID: 20461783
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
PMID: 2306288
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Warren Nielson, PhD
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Chronic Pain