<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/NCT01666639</url>
  </required_header>
  <id_info>
    <org_study_id>0421-FSCP-Z256</org_study_id>
    <nct_id>NCT01666639</nct_id>
  </id_info>
  <brief_title>Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain</brief_title>
  <acronym>VBT</acronym>
  <official_title>Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsche Rentenversicherung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain&#xD;
      has proven its short-term effectiveness. Exercise therapy plays a major role in such a&#xD;
      combination of treatments. There is a considerable need to develop theory-based exercise&#xD;
      interventions which foster a long-term adherence to physical activity. Furthermore, an&#xD;
      integration of behavioral elements such as coping competencies regarding back pain is needed.&#xD;
      It is not yet clear, which specific part of multidisciplinary rehabilitation causes its&#xD;
      effects. The role of exercise therapy has yet to be investigated. Aim of this study is the&#xD;
      implementation of a standardized behavioral exercise therapy into an existing&#xD;
      behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is&#xD;
      that the participation in the behavioral exercise therapy leads to greater short- and&#xD;
      long-term improvements in functional capacity compared to the usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)</measure>
    <time_frame>one year</time_frame>
    <description>The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)</measure>
    <time_frame>one year</time_frame>
    <description>The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)</measure>
    <time_frame>one year</time_frame>
    <description>Three items to assess the pain intensity felt by participants at the moment, as well as during the last six months (mean and maximum pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)</measure>
    <time_frame>one year</time_frame>
    <description>Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)</measure>
    <time_frame>one year</time_frame>
    <description>The HAPA variables include a stage assessment of behaviour change: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me) Further more, the HAPA variables include a validation item (&quot;Since when are you regularly active as you are now?&quot;) and sets of items about the participants' intention, self-efficacy, action and coping planning, risk perception, expectations of consequences of physical activity behaviour and action control regarding physical activity. See Schwarzer et al., 2011 (Rehabilitation psychology 56(3), 161-170) for more details. Furthermore, experiences with physical activity are included (Fleig et al., 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (PHQ-D) (Löwe et al., 2002)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress scale (Cohen, Williamson, 1988)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes towards performing sports (Brand, 2006)</measure>
    <time_frame>one year</time_frame>
    <description>Four items assess the attitudes towards performing physical activity which are based on cognitions (e.g. &quot;When I think about it, I regard physical activity as: not healthy -- very healthy&quot;). Four items assess the attitudes based on affective judgement (e.g. &quot;When I think about bein physically active, I feel not satisfied -- very satisfied&quot;). Each of the eight items is rated on a 7-point scale in between the two poles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">351</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Medical Rehabilitation plus behavioral exercise therapy</intervention_name>
    <description>The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An &quot;Behavioral Exercise Therapy&quot; (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Behavioral Medical Rehabilitation</intervention_name>
    <description>The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more &quot;traditional&quot; concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (ICD-10):&#xD;
&#xD;
          -  F45.4 Persistent somatoform pain disorder&#xD;
&#xD;
          -  F45.41 Chronic pain disorder with somatic and psychological factors&#xD;
&#xD;
          -  F54 Psychological and behavioural factors associated with disorders or diseases&#xD;
             classified elsewhere&#xD;
&#xD;
          -  M51.2 Other specified intervertebral disc displacement&#xD;
&#xD;
          -  M51.3 Other specified intervertebral disc degeneration&#xD;
&#xD;
          -  M51.4 Schmorl's nodes&#xD;
&#xD;
          -  M51.8 Other specified intervertebral disc disorders&#xD;
&#xD;
          -  M51.9 Intervertebral disc disorder, unspecified&#xD;
&#xD;
          -  M53.8 Other specified dorsopathies&#xD;
&#xD;
          -  M53.9 dorsophathy, unspecified&#xD;
&#xD;
          -  M54.4 Lumbago with sciatica&#xD;
&#xD;
          -  M54.5 Low back pain&#xD;
&#xD;
          -  M54.6 Pain in thoracic spine&#xD;
&#xD;
          -  M54.8 Other dorsalgia&#xD;
&#xD;
          -  M54.9 Dorsalgia, unspecified&#xD;
&#xD;
          -  R52.2 Other chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)&#xD;
&#xD;
          -  severely limited health status (comorbidity)&#xD;
&#xD;
          -  serious impairment of vision and hearing (not corrected)&#xD;
&#xD;
          -  serious psychiatric codiagnosis (exkl. see inclusion criteria)&#xD;
&#xD;
          -  inability to speak german&#xD;
&#xD;
          -  pension claim (§51 SGB V - german law)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Sport Science and Sport</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91058</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paracelsus-Klinik an der Gande</name>
      <address>
        <city>Bad Gandersheim</city>
        <state>Lower Saxony</state>
        <zip>37581</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Weser</name>
      <address>
        <city>Bad Pyrmont</city>
        <state>Lower Saxony</state>
        <zip>31812</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.forschung-patientenorientierung.de/index.php/projekte/zweite-foerderphase/modul-zwei-phase-2/vmo-vbt-pfeifer.html</url>
    <description>Homepage: Research funding for care-oriented research &quot;Chronic diseases and patient orientation&quot;</description>
  </link>
  <reference>
    <citation>Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.</citation>
    <PMID>23496822</PMID>
  </reference>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>June 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>January 26, 2014</last_update_submitted>
  <last_update_submitted_qc>January 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Klaus Pfeifer</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <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/NCT01666639
org study id: 0421-FSCP-Z256
nct id: NCT01666639
lead sponsor: 
collaborator: 
has dmc: No
Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain
      has proven its short-term effectiveness. Exercise therapy plays a major role in such a
      combination of treatments. There is a considerable need to develop theory-based exercise
      interventions which foster a long-term adherence to physical activity. Furthermore, an
      integration of behavioral elements such as coping competencies regarding back pain is needed.
      It is not yet clear, which specific part of multidisciplinary rehabilitation causes its
      effects. The role of exercise therapy has yet to be investigated. Aim of this study is the
      implementation of a standardized behavioral exercise therapy into an existing
      behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is
      that the participation in the behavioral exercise therapy leads to greater short- and
      long-term improvements in functional capacity compared to the usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
time frame: one year
description: The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).
measure: Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
time frame: one year
description: The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.
measure: Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
time frame: one year
description: Three items to assess the pain intensity felt by participants at the moment, as well as during the last six months (mean and maximum pain).
measure: Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
time frame: one year
description: Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain.
measure: Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
time frame: one year
measure: HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
time frame: one year
description: The HAPA variables include a stage assessment of behaviour change: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me) Further more, the HAPA variables include a validation item ("Since when are you regularly active as you are now?") and sets of items about the participants' intention, self-efficacy, action and coping planning, risk perception, expectations of consequences of physical activity behaviour and action control regarding physical activity. See Schwarzer et al., 2011 (Rehabilitation psychology 56(3), 161-170) for more details. Furthermore, experiences with physical activity are included (Fleig et al., 2011).
measure: Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
time frame: one year
measure: Depression (PHQ-D) (Löwe et al., 2002)
time frame: one year
measure: Perceived Stress scale (Cohen, Williamson, 1988)
time frame: one year
measure: Attitudes towards performing sports (Brand, 2006)
time frame: one year
description: Four items assess the attitudes towards performing physical activity which are based on cognitions (e.g. "When I think about it, I regard physical activity as: not healthy -- very healthy"). Four items assess the attitudes based on affective judgement (e.g. "When I think about bein physically active, I feel not satisfied -- very satisfied"). Each of the eight items is rated on a 7-point scale in between the two poles.
measure: Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
time frame: one year
measure: Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
time frame: one year
measure: Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
time frame: one year
arm group label: Control Group
arm group type: Active Comparator
arm group label: Intervention Group
arm group type: Experimental
intervention type: Behavioral
intervention name: Behavioral Medical Rehabilitation plus behavioral exercise therapy
description: The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Usual Behavioral Medical Rehabilitation
description: The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Germany
url: http://www.forschung-patientenorientierung.de/index.php/projekte/zweite-foerderphase/modul-zwei-phase-2/vmo-vbt-pfeifer.html
description: Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"
citation: Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.
PMID: 23496822
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg
investigator full name: Prof. Dr. Klaus Pfeifer
investigator title: Prof. Dr.
mesh term: Back Pain
mesh term: Low Back Pain