<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/NCT01705600</url>
  </required_header>
  <id_info>
    <org_study_id>23210</org_study_id>
    <nct_id>NCT01705600</nct_id>
  </id_info>
  <brief_title>Verbalization in Patients With Non-specific Low Back Pain and Central Sensitization</brief_title>
  <official_title>Protocol for the Evaluation of the Effects of Limiting Verbal Complaints on Pain and Pain Catastrophizing in Individuals With LBP Who Are in a State of Central Sensitization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keystone Rehabilitation Systems</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keystone Rehabilitation Systems</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to examine the effects of limiting complaints on pain and&#xD;
      pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of&#xD;
      central sensitization (CS).&#xD;
&#xD;
      The study will be performed on individuals who have LBP and are in a state of CS. CS is&#xD;
      classified as a type of pain which has the following dominant features: pain that is&#xD;
      disproportionate to the nature or extent of injury/pathology; disproportionate,&#xD;
      non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing&#xD;
      factors; strong association with maladaptive psychological factors&#xD;
&#xD;
      ; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been&#xD;
      demonstrated to have discriminative validity for diagnosing CS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a multicenter, randomized (1:1) controlled trial with an experimental and&#xD;
      control group. The control group will be treated as the clinician wishes and will be given a&#xD;
      bracelet to wear during treatment. The experimental group will be treated as the clinician&#xD;
      wishes as well as given a bracelet and a journal with the following instructions:&#xD;
&#xD;
      The goal of this bracelet is to help you recognize your verbal complaints, which we believe&#xD;
      may be related to your pain. We are asking that you wear it and follow these rules:&#xD;
&#xD;
        1. Place the bracelet on either wrist. Please identify in the journal which wrist you have&#xD;
           placed it on and the date.&#xD;
&#xD;
        2. If you verbally complain about Anything, including your pain, switch it to the other&#xD;
           wrist, identify the date, wrist switched to, and complaint. Internal complaints and&#xD;
           thoughts are allowed.&#xD;
&#xD;
        3. Indicate if this complaint made you feel better, worse or the same.&#xD;
&#xD;
      We want you to attempt to limit your complaints through altering your wording to express a&#xD;
      way in which you could make your situation better. For example, instead of saying &quot;it is way&#xD;
      too cold outside&quot; say, &quot;I could have worn more clothes today and I would be less cold&quot;.&#xD;
&#xD;
      Participating clinicians will complete a power-point educational session in which they will&#xD;
      be trained on the randomization process, the rules of the bracelet and goals of this study. A&#xD;
      short education piece on central sensitization will also be provided. Each clinician will&#xD;
      consent that they have successfully completed this and understand all aspects of&#xD;
      participation. We will also require the clinician to complete a short questionnaire that will&#xD;
      ask the following questions:&#xD;
&#xD;
        1. What is your highest degree of education?&#xD;
&#xD;
        2. Do you have any board certifications or specializations?&#xD;
&#xD;
        3. What type of setting do you treat?&#xD;
&#xD;
        4. How many years have you been a treating clinician?&#xD;
&#xD;
      The clinician will also complete the Pain Attitudes and Beliefs Scale for Physiotherapists&#xD;
      (PABS-PT) which is a self-reported measure that discriminates between a biomedical and a&#xD;
      biopsychosocial orientation of therapists with regard to low back pain management. The&#xD;
      PABS-PT is available in several languages (e.g. English, German, Dutch, Brazilian-Portuguese)&#xD;
      and appears to generate reliable and valid data (Ostelo et al., 2003; Laekeman et al., 2008;&#xD;
      Magalhães et al., 2011; Mutsaers et al., 2012).&#xD;
&#xD;
      The treating clinician will take pain measurements on the visual analogue scale and pain&#xD;
      catastrophizing on the pain catastrophizing scale at week 1, week 4, week 12 and 6-months.&#xD;
      The subjects may be discharged when the clinician feels they have successfully achieved goals&#xD;
      or have reached plateau. We anticipate discharge to be an average 4-6 weeks after beginning&#xD;
      treatment. We are asking that they continue to track progress until 6 months post-enrollment.&#xD;
      The clinician will also ask the patient to rate their global rating of change using the GROC&#xD;
      scale at discharge. A detailed registration of the type of interventions the clinicians apply&#xD;
      will be submitted to the researchers (including the number of treatment sessions) but there&#xD;
      is no restriction on how the clinician treats the patient. In addition, we will ask each&#xD;
      participant to list the drugs which they are taking (including changes while they are a&#xD;
      participant) and any other non-PT interventions they undergo (ie. surgery, injections, etc).&#xD;
      This will be crucial for estimating the 'real' treatment effect of the experimental&#xD;
      intervention.&#xD;
&#xD;
      Concealed allocation will be performed by using a computer-generated randomized table of&#xD;
      numbers created prior to the study. Individual, sequentially numbered index cards with the&#xD;
      random assigned numbers would then be prepared. These would be folded and placed in sealed&#xD;
      opaque envelopes which each participant would choose. A researcher will then provide a&#xD;
      bracelet with or without instructions, depending on group allocation.&#xD;
&#xD;
      The subjects will not be compensated in any way monetarily. The patient will benefit from the&#xD;
      study in having satisfaction of providing to the pool of physical therapy research.&#xD;
&#xD;
      Each subject will be verbally explained the study as well as provided a consent form for an&#xD;
      agreement of participation. The consent form will highlight the potential risks and benefits&#xD;
      of participation. The subject will sign the consent form and this will be filed within the&#xD;
      physical therapy facility in which the study is being completed. In addition we will ask the&#xD;
      patient that a demographic questionnaire is filled out at baseline that includes the&#xD;
      questions:&#xD;
&#xD;
        1. When did your current episode of back pain begin?&#xD;
&#xD;
        2. How many episodes of back pain have you experienced in your lifetime?&#xD;
&#xD;
        3. What is your age?&#xD;
&#xD;
        4. What is your nationality?&#xD;
&#xD;
        5. What is your gender?&#xD;
&#xD;
        6. What is your education level?&#xD;
&#xD;
        7. Do you expect your back pain will ever resolve?&#xD;
&#xD;
      There are no inherent risks from participation in this study.&#xD;
&#xD;
      The subjects will be a convenience sample who volunteers to participate after being screened&#xD;
      by a Physical Therapist. The Physical Therapist would verbally explain the study as well as&#xD;
      obtain consent through the attached informed consent forms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale for Pain</measure>
    <time_frame>week 1,4,12, 26</time_frame>
    <description>This is the visual analogue scale for pain which is routinely used in Physical Therapy practice. The multiple time frames are to assess a change in subjective pain values throughout the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale</measure>
    <time_frame>Weeks 1,4,12,26</time_frame>
    <description>This scale measures catastrophic thoughts often related to prolonged pain. The multiple time frames are to assess a change in subjective values throughout the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Global Rating of Perceived Change</measure>
    <time_frame>At discharge (Avg. 4-6 weeks after enrollment)</time_frame>
    <description>This rates an individuals perceived change in recovery after physical therapy interventions</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Central Sensitization</condition>
  <condition>Low Back Pain</condition>
  <condition>Pain Catastrophizing</condition>
  <arm_group>
    <arm_group_label>Pain Verbalization Repression Rules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will wear a bracelet with a set of rules which will restrict ones verbalization of pain complaints</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain Verbalization Repression Rules</intervention_name>
    <description>The involved subjects will be randomized to either a bracelet with receive verbal repression guidelines OR just a bracelet. They will receive typical physical therapy interventions for the treatment of low back pain (modalities, exercise, manual treatment) with the only change being the education of the one group to repress verblization of pain complaints. The bracelet is worn as a reminder of the rules given.</description>
    <arm_group_label>Pain Verbalization Repression Rules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Individuals over the age of 18 who present to physical therapy with a clinical diagnosis&#xD;
        of non-specific low back pain.&#xD;
&#xD;
        Their pain must also have the one of the following characteristics:&#xD;
&#xD;
        2a.the pain is disproportionate to the nature or extent of injury/pathology AND/OR 2b.the&#xD;
        pain is disproportionate, non-mechanical, and unpredictable in response to&#xD;
        aggravating/easing factors AND/OR 2c.the pain has a strong association with maladaptive&#xD;
        psychological factors AND/OR 2d. the pain is diffuse/non-anatomic areas of pain/tenderness&#xD;
        to palpation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any red-flags indicating the low back pain is caused by non-musculoskeletal pathology&#xD;
&#xD;
          2. Pain whose origin could be better defined as noceptive (intermittent and sharp with&#xD;
             movement or mechanical provocation; pain localized to the area of injury or&#xD;
             dysfunction; clear, proportionate mechanical/anatomical nature to aggravating and&#xD;
             easing factors; pain described as shooting, burning, sharp, electric-like; pain in&#xD;
             association with other dysesthesias; night pain/disturbed sleep; antalgic&#xD;
             postures/movement)&#xD;
&#xD;
          3. Pain whose origin could better be defined as peripheral neuropathic (history of nerve&#xD;
             injury, pathology or mechanical compromise; pain in a dermatomal or cutaneous&#xD;
             distribution; pain/symptoms provocation with movement tests that move or compress&#xD;
             neural tissue (ex. SLR)&#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>Joseph B Brence, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physiotherapy Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keystone Physical Therapy</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keystone Rehabilitation Systems</investigator_affiliation>
    <investigator_full_name>Joseph Brence</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <keyword>Central Sensitization</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Pain</keyword>
  <keyword>Pain Catastrophizing</keyword>
  <keyword>Brence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back 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/NCT01705600
org study id: 23210
nct id: NCT01705600
lead sponsor: 
has dmc: No
The primary goal of this study is to examine the effects of limiting complaints on pain and
      pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of
      central sensitization (CS).

      The study will be performed on individuals who have LBP and are in a state of CS. CS is
      classified as a type of pain which has the following dominant features: pain that is
      disproportionate to the nature or extent of injury/pathology; disproportionate,
      non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing
      factors; strong association with maladaptive psychological factors

      ; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been
      demonstrated to have discriminative validity for diagnosing CS.
This will be a multicenter, randomized (1:1) controlled trial with an experimental and
      control group. The control group will be treated as the clinician wishes and will be given a
      bracelet to wear during treatment. The experimental group will be treated as the clinician
      wishes as well as given a bracelet and a journal with the following instructions:

      The goal of this bracelet is to help you recognize your verbal complaints, which we believe
      may be related to your pain. We are asking that you wear it and follow these rules:

        1. Place the bracelet on either wrist. Please identify in the journal which wrist you have
           placed it on and the date.

        2. If you verbally complain about Anything, including your pain, switch it to the other
           wrist, identify the date, wrist switched to, and complaint. Internal complaints and
           thoughts are allowed.

        3. Indicate if this complaint made you feel better, worse or the same.

      We want you to attempt to limit your complaints through altering your wording to express a
      way in which you could make your situation better. For example, instead of saying "it is way
      too cold outside" say, "I could have worn more clothes today and I would be less cold".

      Participating clinicians will complete a power-point educational session in which they will
      be trained on the randomization process, the rules of the bracelet and goals of this study. A
      short education piece on central sensitization will also be provided. Each clinician will
      consent that they have successfully completed this and understand all aspects of
      participation. We will also require the clinician to complete a short questionnaire that will
      ask the following questions:

        1. What is your highest degree of education?

        2. Do you have any board certifications or specializations?

        3. What type of setting do you treat?

        4. How many years have you been a treating clinician?

      The clinician will also complete the Pain Attitudes and Beliefs Scale for Physiotherapists
      (PABS-PT) which is a self-reported measure that discriminates between a biomedical and a
      biopsychosocial orientation of therapists with regard to low back pain management. The
      PABS-PT is available in several languages (e.g. English, German, Dutch, Brazilian-Portuguese)
      and appears to generate reliable and valid data (Ostelo et al., 2003; Laekeman et al., 2008;
      Magalhães et al., 2011; Mutsaers et al., 2012).

      The treating clinician will take pain measurements on the visual analogue scale and pain
      catastrophizing on the pain catastrophizing scale at week 1, week 4, week 12 and 6-months.
      The subjects may be discharged when the clinician feels they have successfully achieved goals
      or have reached plateau. We anticipate discharge to be an average 4-6 weeks after beginning
      treatment. We are asking that they continue to track progress until 6 months post-enrollment.
      The clinician will also ask the patient to rate their global rating of change using the GROC
      scale at discharge. A detailed registration of the type of interventions the clinicians apply
      will be submitted to the researchers (including the number of treatment sessions) but there
      is no restriction on how the clinician treats the patient. In addition, we will ask each
      participant to list the drugs which they are taking (including changes while they are a
      participant) and any other non-PT interventions they undergo (ie. surgery, injections, etc).
      This will be crucial for estimating the 'real' treatment effect of the experimental
      intervention.

      Concealed allocation will be performed by using a computer-generated randomized table of
      numbers created prior to the study. Individual, sequentially numbered index cards with the
      random assigned numbers would then be prepared. These would be folded and placed in sealed
      opaque envelopes which each participant would choose. A researcher will then provide a
      bracelet with or without instructions, depending on group allocation.

      The subjects will not be compensated in any way monetarily. The patient will benefit from the
      study in having satisfaction of providing to the pool of physical therapy research.

      Each subject will be verbally explained the study as well as provided a consent form for an
      agreement of participation. The consent form will highlight the potential risks and benefits
      of participation. The subject will sign the consent form and this will be filed within the
      physical therapy facility in which the study is being completed. In addition we will ask the
      patient that a demographic questionnaire is filled out at baseline that includes the
      questions:

        1. When did your current episode of back pain begin?

        2. How many episodes of back pain have you experienced in your lifetime?

        3. What is your age?

        4. What is your nationality?

        5. What is your gender?

        6. What is your education level?

        7. Do you expect your back pain will ever resolve?

      There are no inherent risks from participation in this study.

      The subjects will be a convenience sample who volunteers to participate after being screened
      by a Physical Therapist. The Physical Therapist would verbally explain the study as well as
      obtain consent through the attached informed consent forms.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual Analogue Scale for Pain
time frame: week 1,4,12, 26
description: This is the visual analogue scale for pain which is routinely used in Physical Therapy practice. The multiple time frames are to assess a change in subjective pain values throughout the study.
measure: Pain Catastrophizing Scale
time frame: Weeks 1,4,12,26
description: This scale measures catastrophic thoughts often related to prolonged pain. The multiple time frames are to assess a change in subjective values throughout the study.
measure: Global Rating of Perceived Change
time frame: At discharge (Avg. 4-6 weeks after enrollment)
description: This rates an individuals perceived change in recovery after physical therapy interventions
arm group label: Pain Verbalization Repression Rules
arm group type: Experimental
description: This group will wear a bracelet with a set of rules which will restrict ones verbalization of pain complaints
intervention type: Behavioral
intervention name: Pain Verbalization Repression Rules
description: The involved subjects will be randomized to either a bracelet with receive verbal repression guidelines OR just a bracelet. They will receive typical physical therapy interventions for the treatment of low back pain (modalities, exercise, manual treatment) with the only change being the education of the one group to repress verblization of pain complaints. The bracelet is worn as a reminder of the rules given.
arm group label: Pain Verbalization Repression Rules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph B Brence, DPT
role: Principal Investigator
affiliation: Physiotherapy Associates
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Keystone Rehabilitation Systems
investigator full name: Joseph Brence
investigator title: Physical Therapist
mesh term: Back Pain
mesh term: Low Back Pain