xml: <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/NCT06017804</url>
    </required_header>
    <id_info>
      <org_study_id>MRIIRS/FAHS/PT/2022-23/M-010</org_study_id>
      <nct_id>NCT06017804</nct_id>
    </id_info>
    <brief_title>Muscle Energy Technique and Foam Roller Self Myofascial Release in Two-wheeler Riders With Chronic Low Back Pain</brief_title>
    <official_title>A Comparative Study of Muscle Energy Technique and Foam Roller Self-myofascial Release for Chronic Low Back Pain in Two-wheeler Riders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Saud University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Manav Rachna International Institute of Research and Studies (MRIIRS)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King Saud University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Pain in the lower back is a major concern in today's era due to prolonged sitting in&#xD;
        two-wheeler riders, mainly due to hamstring tightness. It also creates physical disability&#xD;
        and impairment in activities of daily living. This study aimed to compare the efficacy of&#xD;
        muscle energy technique (MET) and self-myofascial release (SMFR) using the foam roller on&#xD;
        hamstring flexibility, dynamic balance, and physical disability amongst two-wheeler riders&#xD;
        with chronic low back pain. Participants were randomized into two intervention groups, MET&#xD;
        and SMFR, using the envelope method, with each group having 20 participants. Hamstring&#xD;
        flexibility and range of motion for knee extension and the lower back were assessed using the&#xD;
        active knee extension test and sit and reach test, the dynamic balance was assessed by the&#xD;
        star excursion balance test (SEBT) and physical disability by Roland-Morris Disability&#xD;
        Questionnaire, (RMDQ). Measurements were taken at baseline and after 4-week of intervention.&#xD;
        The level of significance value was set at 95% (p &lt;0.05).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study proved that both SMFR using the foam roller and MET are effective in&#xD;
        improving hamstring muscle flexibility, dynamic balance, and physical disability in&#xD;
        two-wheeler riders with chronic low back pain. Thus, either of the two techniques can be used&#xD;
        for treating bikers with tight hamstrings causing chronic low back pain. Compared to MET,&#xD;
        SMFR using foam rollers was found to be more effective in enhancing hamstring flexibility,&#xD;
        improving balance, and decreasing disability levels on the RMDQ after 4 weeks. This study&#xD;
        will be aware of the necessity of hamstring stretching and balance training among two-wheeler&#xD;
        riders for a prolonged duration on a daily basis and take the initiative to improve their&#xD;
        hamstring flexibility and balance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 14, 2022</start_date>
    <completion_date type="Actual">November 29, 2022</completion_date>
    <primary_completion_date type="Actual">September 23, 2022</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>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hamstring flexibility</measure>
      <time_frame>4 weeks</time_frame>
      <description>Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Active range of motion</measure>
      <time_frame>4 weeks</time_frame>
      <description>Active range of motion was assessed using a sit and reach test (SRT) at baseline and four weeks post-intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic balance</measure>
      <time_frame>4 weeks</time_frame>
      <description>Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Roland-Morris Disability Questionnaire Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>Roland-Morris Disability Questionnaire (RMDQ) was used assessing the physical disability at baseline and four weeks post-intervention. The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">46</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>MET Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received a muscle energy technique</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SMFR Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Received a self-myofascial release technique using a foam roller</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle energy technique</intervention_name>
      <description>Participants were required to adopt a supine position. MET's post-isometric relaxation method was chosen. The therapist gently flexed the patient's hip until the limitation bar-rier was detected. At this stage, isometric contractions against resistance were applied. After that, the patients were told to resist the movement with only 25% of their strength. Before the leg was released, the contraction was maintained for 7-10 seconds. On exhale, the knee joint was straightened (extended) towards its new barrier, and a stretch was applied and maintained through that barrier for 30 seconds. This procedure was carried out six times.</description>
      <arm_group_label>MET Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Self-myofascial release technique</intervention_name>
      <description>A foam roller was rolled from the ischial tuberosity to the back of the knee on the side being tested while the participant remained seated in a long sitting position. Individuals were instructed to keep all of their body weight on the leg being evaluated. They spent 30-40 seconds rolling one hamstring at a time in each set (10 times back and forth).</description>
      <arm_group_label>SMFR Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Two-wheeler riders of either gender between the ages of 20 and 40 years,&#xD;
  &#xD;
            -  Who had ridden at least two hours per day for the previous two years,&#xD;
  &#xD;
            -  Had musculoskeletal pain in the back for the previous three months, and&#xD;
  &#xD;
            -  Had a 15-20-degree loss of knee extension when hips were held in 90-degree flexion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women,&#xD;
  &#xD;
            -  Those with a recent spine or lower limb fracture, recent surgery,&#xD;
  &#xD;
            -  A previous hamstring injury,&#xD;
  &#xD;
            -  Lumbar and lower limb neurological deficits, or limb length disparity.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>AMIR IQBAL, MPT</last_name>
      <role>Study Chair</role>
      <affiliation>King Saud University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University</name>
        <address>
          <city>Riyadh</city>
          <zip>11433</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Saud University</investigator_affiliation>
      <investigator_full_name>AMIR IQBAL</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Hamstring flexibility</keyword>
    <keyword>Muscle Energy technique</keyword>
    <keyword>Self-myofascial release</keyword>
    <keyword>Foam roller</keyword>
    <keyword>Dynamic balance</keyword>
    <keyword>Physical disability</keyword>
    <keyword>Sit and reach test</keyword>
    <keyword>Active knee extension</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>
  
  
text: 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/NCT06017804
  org study id: MRIIRS/FAHS/PT/2022-23/M-010
  nct id: NCT06017804
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Pain in the lower back is a major concern in today's era due to prolonged sitting in
        two-wheeler riders, mainly due to hamstring tightness. It also creates physical disability
        and impairment in activities of daily living. This study aimed to compare the efficacy of
        muscle energy technique (MET) and self-myofascial release (SMFR) using the foam roller on
        hamstring flexibility, dynamic balance, and physical disability amongst two-wheeler riders
        with chronic low back pain. Participants were randomized into two intervention groups, MET
        and SMFR, using the envelope method, with each group having 20 participants. Hamstring
        flexibility and range of motion for knee extension and the lower back were assessed using the
        active knee extension test and sit and reach test, the dynamic balance was assessed by the
        star excursion balance test (SEBT) and physical disability by Roland-Morris Disability
        Questionnaire, (RMDQ). Measurements were taken at baseline and after 4-week of intervention.
        The level of significance value was set at 95% (p <0.05).
  The present study proved that both SMFR using the foam roller and MET are effective in
        improving hamstring muscle flexibility, dynamic balance, and physical disability in
        two-wheeler riders with chronic low back pain. Thus, either of the two techniques can be used
        for treating bikers with tight hamstrings causing chronic low back pain. Compared to MET,
        SMFR using foam rollers was found to be more effective in enhancing hamstring flexibility,
        improving balance, and decreasing disability levels on the RMDQ after 4 weeks. This study
        will be aware of the necessity of hamstring stretching and balance training among two-wheeler
        riders for a prolonged duration on a daily basis and take the initiative to improve their
        hamstring flexibility and balance.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Hamstring flexibility
  time frame: 4 weeks
  description: Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.
  measure: Active range of motion
  time frame: 4 weeks
  description: Active range of motion was assessed using a sit and reach test (SRT) at baseline and four weeks post-intervention.
  measure: Dynamic balance
  time frame: 4 weeks
  description: Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.
  measure: Roland-Morris Disability Questionnaire Scale
  time frame: 4 weeks
  description: Roland-Morris Disability Questionnaire (RMDQ) was used assessing the physical disability at baseline and four weeks post-intervention. The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
  arm group label: MET Group
  arm group type: Experimental
  description: Received a muscle energy technique
  arm group label: SMFR Group
  arm group type: Active Comparator
  description: Received a self-myofascial release technique using a foam roller
  intervention type: Other
  intervention name: Muscle energy technique
  description: Participants were required to adopt a supine position. MET's post-isometric relaxation method was chosen. The therapist gently flexed the patient's hip until the limitation bar-rier was detected. At this stage, isometric contractions against resistance were applied. After that, the patients were told to resist the movement with only 25% of their strength. Before the leg was released, the contraction was maintained for 7-10 seconds. On exhale, the knee joint was straightened (extended) towards its new barrier, and a stretch was applied and maintained through that barrier for 30 seconds. This procedure was carried out six times.
  arm group label: MET Group
  intervention type: Other
  intervention name: Self-myofascial release technique
  description: A foam roller was rolled from the ischial tuberosity to the back of the knee on the side being tested while the participant remained seated in a long sitting position. Individuals were instructed to keep all of their body weight on the leg being evaluated. They spent 30-40 seconds rolling one hamstring at a time in each set (10 times back and forth).
  arm group label: SMFR Group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: AMIR IQBAL, MPT
  role: Study Chair
  affiliation: King Saud University
  facility: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: King Saud University
  investigator full name: AMIR IQBAL
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain