<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/NCT04436003</url>
  </required_header>
  <id_info>
    <org_study_id>910193</org_study_id>
    <nct_id>NCT04436003</nct_id>
  </id_info>
  <brief_title>GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis</brief_title>
  <acronym>GDS</acronym>
  <official_title>Evaluation of &quot;Muscle and Articulation Chains GDS Method&quot; Treatment for Inoperable Low Back Pain Patients - a Randomised, Controlled Pilot Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital of Vestfold</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital of Vestfold</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain&#xD;
      treatment for inoperable spine patients with degenerative changes in the lumbar spine,&#xD;
      compared to &quot;standard treatment&quot; (any other chosen treatment). The pilot study will be&#xD;
      conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of&#xD;
      GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot&#xD;
      study will form the basis for a later full-scale randomized study and the following research&#xD;
      questions will be addressed:&#xD;
&#xD;
        1. To what extent were the criteria for inclusion in the study suitable?&#xD;
&#xD;
        2. How did the recruitment procedure work?&#xD;
&#xD;
        3. How did the participants experience GDS treatment?&#xD;
&#xD;
        4. To what extent were the selected outcome measures suitable at the different evaluation&#xD;
           moments, and which outcome measure tested in this pilot study would be most suitable as&#xD;
           primary outcome measure in a full-scale study? (user experience will be included in the&#xD;
           evaluation)&#xD;
&#xD;
        5. How was the change in the primary outcome measure (Oswestry Disability Index)?&#xD;
&#xD;
        6. What will be the estimated time for inclusion of the required number of participants in&#xD;
           a full-scale study? (required sample size will be based on strength calculation /saving&#xD;
           of the outcome target chosen as primary outcome measure for full scale study) The study&#xD;
           is a pilot study with a randomized controlled design, with follow-up after 3-4 months.&#xD;
           Thirty patients are recruited and receive baseline examination and respond to the&#xD;
           questionnaires before randomization. The patients receive a questionnaire by mail 3-4&#xD;
           months after inclusion (after the treatment is completed for intervention group ). The&#xD;
           pilot study will be one-way blinded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: randomized, controlled trial with intervention and control arm. Recruitment: Patients&#xD;
      are recruited from those relegated from GPs in Vestfold to the spine surgeons at Vestfold&#xD;
      Hospital (SIV) for assessment of surgery. Participants who qualify for the study will be&#xD;
      contacted by the project staff member (Sidsel Lombardo) who will provide the information&#xD;
      about the study. Participants who are interested in participating will be assessed in terms&#xD;
      of the study's inclusion and exclusion criteria. If these are met, the participant will be&#xD;
      explained what the study is based on in detail, both orally and in writing (appendix in REK&#xD;
      application). The participant is then asked if he / she is still willing to participate. They&#xD;
      will then undergo the baseline survey, fill in the forms and then sign the consent&#xD;
      declaration. Afterwards they are randomized to GDS treatment or standard therapy.&#xD;
      Participants have the opportunity to quit along the way without affecting their health care&#xD;
      and regular treatment.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
        -  Women and men aged between 35 to 75 years, with chronic (&gt; 3 months) low back pain, with&#xD;
           or without irradiation in legs.&#xD;
&#xD;
        -  Degenerative changes in the lumbar spine verified on MR. Exclusion criteria&#xD;
&#xD;
        -  Severe psychiatric disorder&#xD;
&#xD;
        -  Comorbidity that prevents the patient from performing exercises and gradually increasing&#xD;
           general activity when the back / leg function permits it.&#xD;
&#xD;
        -  Already had surgery with fixation of the lumbar spine.&#xD;
&#xD;
        -  Pregnancy&#xD;
&#xD;
        -  Being in process of assessing disability insurance or economic compensation for health&#xD;
           reasons.&#xD;
&#xD;
      Randomization procedure: After baseline survey and answered questionnaire, participants will&#xD;
      be randomized to intervention and control group using a data generated randomization sequence&#xD;
      at a 1: 1 ratio. Statisticians at the Musculoskeletal Health Research Group (MUSKHealth.com)&#xD;
      at OsloMet will assist with the randomization sequence.&#xD;
&#xD;
      Blinding: In this study, one cannot blind the participants nor the treating physiotherapist&#xD;
      for which treatment they are receiving. However, research staff who collect and process data&#xD;
      at the 3-4 month follow-up will be blinded to who is randomized to the intervention and&#xD;
      control groups, respectively.&#xD;
&#xD;
      Intervention: The treatment group is examined and evaluated based on the principles of the&#xD;
      &quot;muscle and articulation chains GDS method&quot;, and receive until 8 treatments of one hour. They&#xD;
      meet once a week in the beginning, more seldom towards the end of treatment. The participants&#xD;
      pay for the individual treatments, but half prize of usual physiotherapy rate. The reason is&#xD;
      that there is no extra money in SIV Hospital to provide free treatment, and that patients&#xD;
      today pay regular rates for the same. Participants' follow-up to the intervention will be&#xD;
      logged by the attending physiotherapist. The same applies to apostasy.&#xD;
&#xD;
      Control: The control group receives standard treatment from their GP, possibly referred to&#xD;
      physiotherapy, chiropractor or the treatment option they prefer.&#xD;
&#xD;
      At baseline, imaging diagnostic findings regarding degenerative findings in the spine&#xD;
      obtained from patient records will also be included. Data on function using Oswestry list f&#xD;
      Data collection: Background variables such as age, gender, education level, marital status,&#xD;
      mother tongue, height and weight will only be obtained at baseline (before randomization).&#xD;
&#xD;
      The same applies to mapping the risk of chronic back pain, which will be mapped using the&#xD;
      STarT Back screening form [12].&#xD;
&#xD;
      Imaging diagnostic regarding degenerative findings in the spine obtained from patient records&#xD;
      will also be included.&#xD;
&#xD;
      Functional data using the Oswestry list for functional limitations [10], pain using the VAS&#xD;
      scale [8], health-related quality of life using the EQ-5D [11], risk for chronic back pain&#xD;
      using the StarT Back screening form [12] and work ability will be obtained before and after&#xD;
      intervention (3-4 months). A questionnaire at 3-4 months follow-up will be sent by mail, with&#xD;
      a stamped envelope for return. Patients who do not respond will be reminded twice.&#xD;
&#xD;
      Statistical analysis and sample size: This pilot study will also be used to make a strength&#xD;
      calculation for a full-scale RCT. Nevertheless, if we use minimum clinical important&#xD;
      difference (MCID) estimates in primary outcome measures as a starting point for a strength&#xD;
      calculation, we will get the following reasoning: MCID for ODI has been found to be between 8&#xD;
      and 10 points on the scale from 0 to 10 [10]. Assuming an expected difference between two&#xD;
      groups of 8 ODI points with a standard deviation (SD) of 10 and significance level of 5%,&#xD;
      then we will have 80% strength to detect this difference with a sample of 50 people in each&#xD;
      group. We account for 15% drop-out, ie a full-scale study will require 115 patients. If the&#xD;
      pilot study proves to be able to expect greater differences in ODI scores between the groups,&#xD;
      then this number could be reduced, and vice versa. For this pilot study, the aim is to&#xD;
      include totally 30 participants for intervention and control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2018</start_date>
  <completion_date type="Actual">October 3, 2020</completion_date>
  <primary_completion_date type="Actual">October 3, 2020</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>
    <intervention_model_description>Patients are randomized into intervention or Control Group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator and outcome assessor will be masked for randomisation. It is not possible to mask the patient and treatment provider.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>4 months</time_frame>
    <description>Measures activity limitations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>4 months</time_frame>
    <description>Measures pain on a line 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>4 months</time_frame>
    <description>Health-related quality of life measurement tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Keele Start Back screening tool</measure>
    <time_frame>4 months</time_frame>
    <description>Psychosocial screening profile measurement tool</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Low Back Pain, Recurrent</condition>
  <condition>Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>Muscle and Articulation chains GDS method treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention Group are examined and treated according to the principles of &quot;Muscle and Articulation Chains GDS Method&quot;. They receive GDS treatment individually, up to 8 sessions of 1 hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (treatment as usual)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control Group receives standard treatment from their RGP/ doctor. Some are prescribed physiotherapy or chiropractor treatment, or they choose their own alternatives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle and articulation chains GDS method</intervention_name>
    <description>A physiotherapy method adapting treatment to patient's &quot;terrain&quot;, or psychomorphology, using chosen techniques to balance tension between muscle chains, thus optimalizing posture and mouvement.</description>
    <arm_group_label>Muscle and Articulation chains GDS method treatment</arm_group_label>
    <other_name>Les Chaines Musculaires et Articulaires Methode GDS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, age 35-75 years, with cronic (&gt;3 months) LBP, may have irradiation in&#xD;
             legs.&#xD;
&#xD;
          -  Degenerative changes in the lumbar spine verified on MR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric disorder.&#xD;
&#xD;
          -  Comorbidity that prevents the patient from performing exercises and gradually&#xD;
             increasing general activity when the back /leg function gradually allows it.&#xD;
&#xD;
          -  Already had surgery with fixation of lumbar spine.&#xD;
&#xD;
          -  Being in process of assessing disability insurance or economic compenastion for Health&#xD;
             reasons.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margreth Grotle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo Metropolitan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vestfold Hospital</name>
      <address>
        <city>Larvik</city>
        <zip>3257</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.philippe-campignion.com</url>
    <description>home page of author of books about the method</description>
  </link>
  <link>
    <url>http://www.apgds.com</url>
    <description>association for practitioners</description>
  </link>
  <results_reference>
    <citation>Diaz Arribas MJ, Ramos Sanchez M, Pardo Hervas P, Lopez Chicharro J, Angulo Carrere T, Ortega Molina P, Astasio Arbiza P. Effectiveness of the physical therapy Godelive Denys-Struyf method for nonspecific low back pain: primary care randomized control trial. Spine (Phila Pa 1976). 2009 Jul 1;34(15):1529-38. doi: 10.1097/BRS.0b013e3181aa2771.</citation>
    <PMID>19564761</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital of Vestfold</investigator_affiliation>
    <investigator_full_name>Sidsel Lombardo</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Muscle and articulation chains GDS method</keyword>
  <keyword>pilot RCT</keyword>
  <keyword>Oswestry Disability Index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04436003
org study id: 910193
nct id: NCT04436003
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain
      treatment for inoperable spine patients with degenerative changes in the lumbar spine,
      compared to "standard treatment" (any other chosen treatment). The pilot study will be
      conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of
      GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot
      study will form the basis for a later full-scale randomized study and the following research
      questions will be addressed:

        1. To what extent were the criteria for inclusion in the study suitable?

        2. How did the recruitment procedure work?

        3. How did the participants experience GDS treatment?

        4. To what extent were the selected outcome measures suitable at the different evaluation
           moments, and which outcome measure tested in this pilot study would be most suitable as
           primary outcome measure in a full-scale study? (user experience will be included in the
           evaluation)

        5. How was the change in the primary outcome measure (Oswestry Disability Index)?

        6. What will be the estimated time for inclusion of the required number of participants in
           a full-scale study? (required sample size will be based on strength calculation /saving
           of the outcome target chosen as primary outcome measure for full scale study) The study
           is a pilot study with a randomized controlled design, with follow-up after 3-4 months.
           Thirty patients are recruited and receive baseline examination and respond to the
           questionnaires before randomization. The patients receive a questionnaire by mail 3-4
           months after inclusion (after the treatment is completed for intervention group ). The
           pilot study will be one-way blinded.
Design: randomized, controlled trial with intervention and control arm. Recruitment: Patients
      are recruited from those relegated from GPs in Vestfold to the spine surgeons at Vestfold
      Hospital (SIV) for assessment of surgery. Participants who qualify for the study will be
      contacted by the project staff member (Sidsel Lombardo) who will provide the information
      about the study. Participants who are interested in participating will be assessed in terms
      of the study's inclusion and exclusion criteria. If these are met, the participant will be
      explained what the study is based on in detail, both orally and in writing (appendix in REK
      application). The participant is then asked if he / she is still willing to participate. They
      will then undergo the baseline survey, fill in the forms and then sign the consent
      declaration. Afterwards they are randomized to GDS treatment or standard therapy.
      Participants have the opportunity to quit along the way without affecting their health care
      and regular treatment.

      Inclusion criteria

        -  Women and men aged between 35 to 75 years, with chronic (> 3 months) low back pain, with
           or without irradiation in legs.

        -  Degenerative changes in the lumbar spine verified on MR. Exclusion criteria

        -  Severe psychiatric disorder

        -  Comorbidity that prevents the patient from performing exercises and gradually increasing
           general activity when the back / leg function permits it.

        -  Already had surgery with fixation of the lumbar spine.

        -  Pregnancy

        -  Being in process of assessing disability insurance or economic compensation for health
           reasons.

      Randomization procedure: After baseline survey and answered questionnaire, participants will
      be randomized to intervention and control group using a data generated randomization sequence
      at a 1: 1 ratio. Statisticians at the Musculoskeletal Health Research Group (MUSKHealth.com)
      at OsloMet will assist with the randomization sequence.

      Blinding: In this study, one cannot blind the participants nor the treating physiotherapist
      for which treatment they are receiving. However, research staff who collect and process data
      at the 3-4 month follow-up will be blinded to who is randomized to the intervention and
      control groups, respectively.

      Intervention: The treatment group is examined and evaluated based on the principles of the
      "muscle and articulation chains GDS method", and receive until 8 treatments of one hour. They
      meet once a week in the beginning, more seldom towards the end of treatment. The participants
      pay for the individual treatments, but half prize of usual physiotherapy rate. The reason is
      that there is no extra money in SIV Hospital to provide free treatment, and that patients
      today pay regular rates for the same. Participants' follow-up to the intervention will be
      logged by the attending physiotherapist. The same applies to apostasy.

      Control: The control group receives standard treatment from their GP, possibly referred to
      physiotherapy, chiropractor or the treatment option they prefer.

      At baseline, imaging diagnostic findings regarding degenerative findings in the spine
      obtained from patient records will also be included. Data on function using Oswestry list f
      Data collection: Background variables such as age, gender, education level, marital status,
      mother tongue, height and weight will only be obtained at baseline (before randomization).

      The same applies to mapping the risk of chronic back pain, which will be mapped using the
      STarT Back screening form [12].

      Imaging diagnostic regarding degenerative findings in the spine obtained from patient records
      will also be included.

      Functional data using the Oswestry list for functional limitations [10], pain using the VAS
      scale [8], health-related quality of life using the EQ-5D [11], risk for chronic back pain
      using the StarT Back screening form [12] and work ability will be obtained before and after
      intervention (3-4 months). A questionnaire at 3-4 months follow-up will be sent by mail, with
      a stamped envelope for return. Patients who do not respond will be reminded twice.

      Statistical analysis and sample size: This pilot study will also be used to make a strength
      calculation for a full-scale RCT. Nevertheless, if we use minimum clinical important
      difference (MCID) estimates in primary outcome measures as a starting point for a strength
      calculation, we will get the following reasoning: MCID for ODI has been found to be between 8
      and 10 points on the scale from 0 to 10 [10]. Assuming an expected difference between two
      groups of 8 ODI points with a standard deviation (SD) of 10 and significance level of 5%,
      then we will have 80% strength to detect this difference with a sample of 50 people in each
      group. We account for 15% drop-out, ie a full-scale study will require 115 patients. If the
      pilot study proves to be able to expect greater differences in ODI scores between the groups,
      then this number could be reduced, and vice versa. For this pilot study, the aim is to
      include totally 30 participants for intervention and control groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized into intervention or Control Group.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator and outcome assessor will be masked for randomisation. It is not possible to mask the patient and treatment provider.
measure: Oswestry Disability Index
time frame: 4 months
description: Measures activity limitations
measure: Visual analogue scale (VAS)
time frame: 4 months
description: Measures pain on a line 0-100
measure: EQ-5D-5L
time frame: 4 months
description: Health-related quality of life measurement tool
measure: The Keele Start Back screening tool
time frame: 4 months
description: Psychosocial screening profile measurement tool
arm group label: Muscle and Articulation chains GDS method treatment
arm group type: Experimental
description: Participants in the intervention Group are examined and treated according to the principles of "Muscle and Articulation Chains GDS Method". They receive GDS treatment individually, up to 8 sessions of 1 hour.
arm group label: Control (treatment as usual)
arm group type: No Intervention
description: The Control Group receives standard treatment from their RGP/ doctor. Some are prescribed physiotherapy or chiropractor treatment, or they choose their own alternatives.
intervention type: Behavioral
intervention name: Muscle and articulation chains GDS method
description: A physiotherapy method adapting treatment to patient's "terrain", or psychomorphology, using chosen techniques to balance tension between muscle chains, thus optimalizing posture and mouvement.
arm group label: Muscle and Articulation chains GDS method treatment
other name: Les Chaines Musculaires et Articulaires Methode GDS
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Margreth Grotle, PhD
role: Principal Investigator
affiliation: Oslo Metropolitan University
facility: 
country: Norway
url: http://www.philippe-campignion.com
description: home page of author of books about the method
url: http://www.apgds.com
description: association for practitioners
citation: Diaz Arribas MJ, Ramos Sanchez M, Pardo Hervas P, Lopez Chicharro J, Angulo Carrere T, Ortega Molina P, Astasio Arbiza P. Effectiveness of the physical therapy Godelive Denys-Struyf method for nonspecific low back pain: primary care randomized control trial. Spine (Phila Pa 1976). 2009 Jul 1;34(15):1529-38. doi: 10.1097/BRS.0b013e3181aa2771.
PMID: 19564761
responsible party type: Principal Investigator
investigator affiliation: The Hospital of Vestfold
investigator full name: Sidsel Lombardo
investigator title: Physiotherapist
mesh term: Intervertebral Disc Degeneration
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No