<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/NCT04498572</url>
  </required_header>
  <id_info>
    <org_study_id>2393</org_study_id>
    <nct_id>NCT04498572</nct_id>
  </id_info>
  <brief_title>The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain</brief_title>
  <official_title>The Effect of Dry Needling in the Gluteus Medius Muscle With Active Physiotherapy Versus Placebo Dry Needling With Active Physiotherapy in Patients With Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Haifa</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>
      The effectiveness of dry needling of the Gluteus Medius muscle in combination with active&#xD;
      exercises will be examined compared with sham needling with active exercises in low back pain&#xD;
      (LBP) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To examine if dry needling in combination with active physiotherapy is more&#xD;
      effective in reducing pain and increase activity of daily living, range of motion and muscle&#xD;
      strength in patients with chronic low back pain compared to sham dry needling in combination&#xD;
      with active physiotherapy.&#xD;
&#xD;
      Methods: the study will include individuals with non-specific LBP over 3 months.&#xD;
&#xD;
      Subjects will be divided randomly into two research groups, both will receive physiotherapy&#xD;
      including mobility, strengthening and stretching exercises. Intervention group, additionally&#xD;
      to exercises, will receive dry needling to the Gluteus Medius muscle by inserting a needle to&#xD;
      a trigger point until a visible involuntary twitch in the muscle appears. Sham needling will&#xD;
      be applied by needling with pre-cut and smoothed needles that will not penetrate the skin.&#xD;
&#xD;
      Both groups will receive two treatments per week and up to six treatments overall, evaluation&#xD;
      will be performed before and after the series of treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">January 15, 2023</completion_date>
  <primary_completion_date type="Actual">January 15, 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>two groups. research group will receive dry needling and control group will receive sham dry needling.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>participants will not be aware of the group they were assigned</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change in visual analog scale (VAS)</measure>
    <time_frame>baseline and at 3 weeks</time_frame>
    <description>assessing pain on a scale from 0 (no pain) to 10 (most sever pain). Higher scores means worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Modified Oswestry Disability Index</measure>
    <time_frame>baseline and at 3 weeks</time_frame>
    <description>questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP. Higher scores means worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global rating of change</measure>
    <time_frame>3 weeks</time_frame>
    <description>a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hip abductors muscle strength</measure>
    <time_frame>baseline and 3 weeks</time_frame>
    <description>muscle strength in Newton, assessed by an hand held dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lumbar flexion range of motion</measure>
    <time_frame>baseline and 3 weeks</time_frame>
    <description>lumbar flexion assessment by bending forward and measuring distance of fingers from the floor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>research group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active exercises and dry needling for the Gluteus medius muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>active exercises and sham dry needling for the Gluteus medius muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dry needling</intervention_name>
    <description>dry needling for Gluteus Medius muscle in combination with exercises</description>
    <arm_group_label>research group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham dry needling</intervention_name>
    <description>sham dry needling for Gluteus Medius muscle in combination with exercises</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main complaint of nonspecific LBP over a 3 month period&#xD;
&#xD;
          -  VAS &gt; 3 at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  two or more of the following signs are present on physical examination: lower&#xD;
             extremity weakness in a myotome distribution, decreased sensation in a dermatomal&#xD;
             distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a&#xD;
             positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.&#xD;
&#xD;
          -  Symptoms began immediately after a significant trauma (motor vehicle accident, fall&#xD;
             from a height) and subjects were not been screened for possible fractures.&#xD;
&#xD;
          -  Physical therapy or chiropractic treatment for LBP was provided during the 6 months&#xD;
             prior to participation in the study or are currently being treated.&#xD;
&#xD;
          -  presence of contraindication for dry needling&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  past back or pelvic surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gali Dar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gali Dar, Department of Physical Therapy, University of Haifa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haifa University, Department of PHysical Therapy</name>
      <address>
        <city>Haifa</city>
        <zip>31905</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>Cooper NA, Scavo KM, Strickland KJ, Tipayamongkol N, Nicholson JD, Bewyer DC, Sluka KA. Prevalence of gluteus medius weakness in people with chronic low back pain compared to healthy controls. Eur Spine J. 2016 Apr;25(4):1258-65. doi: 10.1007/s00586-015-4027-6. Epub 2015 May 26.</citation>
    <PMID>26006705</PMID>
  </results_reference>
  <results_reference>
    <citation>Dar G, Hicks GE. The immediate effect of dry needling on multifidus muscles' function in healthy individuals. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):273-278. doi: 10.3233/BMR-150624.</citation>
    <PMID>26406203</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>following study completion, a paper will be submitted to international professional journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>6 months following end of study</ipd_time_frame>
  </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/NCT04498572
org study id: 2393
nct id: NCT04498572
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effectiveness of dry needling of the Gluteus Medius muscle in combination with active
      exercises will be examined compared with sham needling with active exercises in low back pain
      (LBP) patients.
Objectives: To examine if dry needling in combination with active physiotherapy is more
      effective in reducing pain and increase activity of daily living, range of motion and muscle
      strength in patients with chronic low back pain compared to sham dry needling in combination
      with active physiotherapy.

      Methods: the study will include individuals with non-specific LBP over 3 months.

      Subjects will be divided randomly into two research groups, both will receive physiotherapy
      including mobility, strengthening and stretching exercises. Intervention group, additionally
      to exercises, will receive dry needling to the Gluteus Medius muscle by inserting a needle to
      a trigger point until a visible involuntary twitch in the muscle appears. Sham needling will
      be applied by needling with pre-cut and smoothed needles that will not penetrate the skin.

      Both groups will receive two treatments per week and up to six treatments overall, evaluation
      will be performed before and after the series of treatments.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups. research group will receive dry needling and control group will receive sham dry needling.
primary purpose: Treatment
masking: Single (Participant)
masking description: participants will not be aware of the group they were assigned
measure: change in visual analog scale (VAS)
time frame: baseline and at 3 weeks
description: assessing pain on a scale from 0 (no pain) to 10 (most sever pain). Higher scores means worse outcome.
measure: Change in Modified Oswestry Disability Index
time frame: baseline and at 3 weeks
description: questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP. Higher scores means worse outcome.
measure: Global rating of change
time frame: 3 weeks
description: a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.
measure: Change in hip abductors muscle strength
time frame: baseline and 3 weeks
description: muscle strength in Newton, assessed by an hand held dynamometer
measure: Change in lumbar flexion range of motion
time frame: baseline and 3 weeks
description: lumbar flexion assessment by bending forward and measuring distance of fingers from the floor
arm group label: research group
arm group type: Experimental
description: active exercises and dry needling for the Gluteus medius muscle
arm group label: control group
arm group type: Sham Comparator
description: active exercises and sham dry needling for the Gluteus medius muscle
intervention type: Other
intervention name: dry needling
description: dry needling for Gluteus Medius muscle in combination with exercises
arm group label: research group
intervention type: Other
intervention name: sham dry needling
description: sham dry needling for Gluteus Medius muscle in combination with exercises
arm group label: control group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gali Dar, PhD
role: Principal Investigator
affiliation: Gali Dar, Department of Physical Therapy, University of Haifa
facility: 
country: Israel
citation: Cooper NA, Scavo KM, Strickland KJ, Tipayamongkol N, Nicholson JD, Bewyer DC, Sluka KA. Prevalence of gluteus medius weakness in people with chronic low back pain compared to healthy controls. Eur Spine J. 2016 Apr;25(4):1258-65. doi: 10.1007/s00586-015-4027-6. Epub 2015 May 26.
PMID: 26006705
citation: Dar G, Hicks GE. The immediate effect of dry needling on multifidus muscles' function in healthy individuals. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):273-278. doi: 10.3233/BMR-150624.
PMID: 26406203
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: following study completion, a paper will be submitted to international professional journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 6 months following end of study