<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/NCT03270631</url>
  </required_header>
  <id_info>
    <org_study_id>FM&amp;KCStudy</org_study_id>
    <nct_id>NCT03270631</nct_id>
  </id_info>
  <brief_title>Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain</brief_title>
  <official_title>Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Loisto Terveys, Oulu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fysios Kastelli, Oulu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faskia-Markus, Oulu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oulu University Hospital</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>
      Subjects are recruited from the attendees of the multidisciplinary low back pain&#xD;
      rehabilitation group before it takes place in University Hospital of Oulu at Physical and&#xD;
      Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks&#xD;
      before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor&#xD;
      at PRM unit. The volunteered subjects are invited to the briefing of the study and those who&#xD;
      are willing to participate, they filled in several questionnaires about pain, participation,&#xD;
      disability and mood. After that the subjects are measured at baseline measurement. Subjects&#xD;
      are randomized into the five groups. After the 3 months treatment and training the follow-up&#xD;
      measurements are performed. Same questionnaires are filled in at that point as well. At 6 and&#xD;
      12 months the follow-up questionnaires (same as before) are sent to subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are recruited from the attendees of the multidisciplinary low back pain&#xD;
      rehabilitation group before it takes place in University Hospital of Oulu at Physical and&#xD;
      Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks&#xD;
      before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor&#xD;
      at PRM unit. The volunteered subjects are invited to the briefing of the study and those who&#xD;
      are willing to participate, they filled in several questionnaires about pain, participation,&#xD;
      disability and mood. After that the subjects are measured at baseline measurement. Subjects&#xD;
      are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and&#xD;
      movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and&#xD;
      sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the&#xD;
      measurements are blinded to each other. Physical therapist who is performing measurements is&#xD;
      also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments&#xD;
      of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only&#xD;
      university hospital rehabilitation and will participate into the baseline and follow-up&#xD;
      measurements. After the 3 months treatment and training the follow-up measurements are&#xD;
      performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up&#xD;
      questionnaires (same as before) are sent to subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</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>Five groups: 1) control, 2) fascial manipulation (FM) + movement control exercise (MCE), 3) FM + sham-MCE, 4) MCE + sham-FM and 5) sham-FM and sham-MCE</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant are not aware which treatment and exercises they will have, physical therapist who perform treatments and exercise prescription were blinded for measurements and each others work. Outcome assessor was blinded for baseline study results and treatment groups. Investigator was blinded for all the work done by others.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Specific Functional Scale (PSFS)</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Disability index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tampa Scale of Kinesiophobia</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual analogue Scale</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Linton Örebro</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Psychosocial risk factor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Start back</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Screening tool of the psychosocial risk factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Movement control tests</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>Clinical tests for LBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spinal mouse</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>Mobility of the spine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balance measured with computer</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>Power plate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mobility of the hips</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>Hip ROM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Two-point discrimination</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>How far apart subject is able to feel two distinctive point of touch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lef-right discrimination</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>How subject is able to understand right and left of the back</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ultrasound of the fascia</measure>
    <time_frame>Change from baseline at 3 month</time_frame>
    <description>Several fascial structures are measured</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Low Back Pain, Recurrent</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Multidisciplinary rehabilitation, no interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FM and MCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have 4-5 times of fascial manipulation (FM) treatment and 4-6 times movement control exercises (MCE) at home to be done based on movement control testing (MCT). Both are given in 3 month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FM and sham-MCE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FM 4-5 times in 3 months and 4 general exercise prescription.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCE and sham-FM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-MCE and sham-FM</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FM and MCE</intervention_name>
    <description>Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.</description>
    <arm_group_label>FM and MCE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FM and sham-MCE</intervention_name>
    <description>Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.</description>
    <arm_group_label>FM and sham-MCE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MCE and sham-FM</intervention_name>
    <description>Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.</description>
    <arm_group_label>MCE and sham-FM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham-MCE and sham-FM</intervention_name>
    <description>Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.</description>
    <arm_group_label>Sham-MCE and sham-FM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic non-operatively treated low back pain or pain after the low back operation.&#xD;
             Participation in multidisciplinary rehabilitation at University Hospital of Oulu.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specific low back pain cause and earlier fascial manipulation treatment given.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jani Takatalo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oulu University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Oulu</name>
      <address>
        <city>Oulu</city>
        <zip>90029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 23, 2022</last_update_submitted>
  <last_update_submitted_qc>April 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oulu University Hospital</investigator_affiliation>
    <investigator_full_name>Jani Takatalo</investigator_full_name>
    <investigator_title>Resident of PRM, PhD, MD</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/NCT03270631
org study id: FM&KCStudy
nct id: NCT03270631
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subjects are recruited from the attendees of the multidisciplinary low back pain
      rehabilitation group before it takes place in University Hospital of Oulu at Physical and
      Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks
      before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor
      at PRM unit. The volunteered subjects are invited to the briefing of the study and those who
      are willing to participate, they filled in several questionnaires about pain, participation,
      disability and mood. After that the subjects are measured at baseline measurement. Subjects
      are randomized into the five groups. After the 3 months treatment and training the follow-up
      measurements are performed. Same questionnaires are filled in at that point as well. At 6 and
      12 months the follow-up questionnaires (same as before) are sent to subjects.
Subjects are recruited from the attendees of the multidisciplinary low back pain
      rehabilitation group before it takes place in University Hospital of Oulu at Physical and
      Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks
      before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor
      at PRM unit. The volunteered subjects are invited to the briefing of the study and those who
      are willing to participate, they filled in several questionnaires about pain, participation,
      disability and mood. After that the subjects are measured at baseline measurement. Subjects
      are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and
      movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and
      sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the
      measurements are blinded to each other. Physical therapist who is performing measurements is
      also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments
      of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only
      university hospital rehabilitation and will participate into the baseline and follow-up
      measurements. After the 3 months treatment and training the follow-up measurements are
      performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up
      questionnaires (same as before) are sent to subjects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Five groups: 1) control, 2) fascial manipulation (FM) + movement control exercise (MCE), 3) FM + sham-MCE, 4) MCE + sham-FM and 5) sham-FM and sham-MCE
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participant are not aware which treatment and exercises they will have, physical therapist who perform treatments and exercise prescription were blinded for measurements and each others work. Outcome assessor was blinded for baseline study results and treatment groups. Investigator was blinded for all the work done by others.
measure: Change in Patient Specific Functional Scale (PSFS)
time frame: Baseline, 3, 6 and 12 months
description: Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
measure: Change in Oswestry
time frame: Baseline, 3, 6 and 12 months
description: Disability index
measure: Change in PROMIS
time frame: Baseline, 3, 6 and 12 months
description: Quality of life
measure: Change in Tampa Scale of Kinesiophobia
time frame: Baseline, 3, 6 and 12 months
description: Fear of movement
measure: Change in Visual analogue Scale
time frame: Baseline, 3, 6 and 12 months
description: Pain scale
measure: Change in Linton Örebro
time frame: Baseline, 3, 6 and 12 months
description: Psychosocial risk factor
measure: Change in Start back
time frame: Baseline, 3, 6 and 12 months
description: Screening tool of the psychosocial risk factors
measure: Change in Movement control tests
time frame: Change from baseline at 3 month
description: Clinical tests for LBP
measure: Change in Spinal mouse
time frame: Change from baseline at 3 month
description: Mobility of the spine
measure: Change in Balance measured with computer
time frame: Change from baseline at 3 month
description: Power plate
measure: Change in Mobility of the hips
time frame: Change from baseline at 3 month
description: Hip ROM
measure: Change in Two-point discrimination
time frame: Change from baseline at 3 month
description: How far apart subject is able to feel two distinctive point of touch
measure: Change in Lef-right discrimination
time frame: Change from baseline at 3 month
description: How subject is able to understand right and left of the back
measure: Change in Ultrasound of the fascia
time frame: Change from baseline at 3 month
description: Several fascial structures are measured
arm group label: Control
arm group type: No Intervention
description: Multidisciplinary rehabilitation, no interventions
arm group label: FM and MCE
arm group type: Experimental
description: Subjects will have 4-5 times of fascial manipulation (FM) treatment and 4-6 times movement control exercises (MCE) at home to be done based on movement control testing (MCT). Both are given in 3 month period.
arm group label: FM and sham-MCE
arm group type: Other
description: FM 4-5 times in 3 months and 4 general exercise prescription.
arm group label: MCE and sham-FM
arm group type: Other
description: Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises.
arm group label: Sham-MCE and sham-FM
arm group type: Sham Comparator
description: 4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points.
intervention type: Other
intervention name: FM and MCE
description: Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
arm group label: FM and MCE
intervention type: Other
intervention name: FM and sham-MCE
description: Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
arm group label: FM and sham-MCE
intervention type: Other
intervention name: MCE and sham-FM
description: Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.
arm group label: MCE and sham-FM
intervention type: Other
intervention name: Sham-MCE and sham-FM
description: Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
arm group label: Sham-MCE and sham-FM
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jani Takatalo, PhD
role: Principal Investigator
affiliation: Oulu University Hospital
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Oulu University Hospital
investigator full name: Jani Takatalo
investigator title: Resident of PRM, PhD, MD
mesh term: Back Pain
mesh term: Low Back Pain