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The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
dry needling
sham dry needling
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Main complaint of nonspecific LBP over a 3 month period
  • VAS > 3 at baseline

Exclusion Criteria:

  • two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.
  • Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures.
  • Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated.
  • presence of contraindication for dry needling
  • pregnancy
  • past back or pelvic surgery

Sites / Locations

  • Haifa University, Department of PHysical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

research group

control group

Arm Description

active exercises and dry needling for the Gluteus medius muscle

active exercises and sham dry needling for the Gluteus medius muscle

Outcomes

Primary Outcome Measures

change in visual analog scale (VAS)
assessing pain on a scale from 0 (no pain) to 10 (most sever pain). Higher scores means worse outcome.
Change in Modified Oswestry Disability Index
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.
Global rating of change
a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.

Secondary Outcome Measures

Change in hip abductors muscle strength
muscle strength in Newton, assessed by an hand held dynamometer
Change in lumbar flexion range of motion
lumbar flexion assessment by bending forward and measuring distance of fingers from the floor

Full Information

First Posted
July 27, 2020
Last Updated
March 15, 2023
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT04498572
Brief Title
The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups. research group will receive dry needling and control group will receive sham dry needling.
Masking
Participant
Masking Description
participants will not be aware of the group they were assigned
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
research group
Arm Type
Experimental
Arm Description
active exercises and dry needling for the Gluteus medius muscle
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
active exercises and sham dry needling for the Gluteus medius muscle
Intervention Type
Other
Intervention Name(s)
dry needling
Intervention Description
dry needling for Gluteus Medius muscle in combination with exercises
Intervention Type
Other
Intervention Name(s)
sham dry needling
Intervention Description
sham dry needling for Gluteus Medius muscle in combination with exercises
Primary Outcome Measure Information:
Title
change in visual analog scale (VAS)
Description
assessing pain on a scale from 0 (no pain) to 10 (most sever pain). Higher scores means worse outcome.
Time Frame
baseline and at 3 weeks
Title
Change in Modified Oswestry Disability Index
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.
Time Frame
baseline and at 3 weeks
Title
Global rating of change
Description
a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in hip abductors muscle strength
Description
muscle strength in Newton, assessed by an hand held dynamometer
Time Frame
baseline and 3 weeks
Title
Change in lumbar flexion range of motion
Description
lumbar flexion assessment by bending forward and measuring distance of fingers from the floor
Time Frame
baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Main complaint of nonspecific LBP over a 3 month period VAS > 3 at baseline Exclusion Criteria: two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test. Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures. Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated. presence of contraindication for dry needling pregnancy past back or pelvic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
Gali Dar, Department of Physical Therapy, University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haifa University, Department of PHysical Therapy
City
Haifa
ZIP/Postal Code
31905
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
following study completion, a paper will be submitted to international professional journal
IPD Sharing Time Frame
6 months following end of study
Citations:
PubMed Identifier
26006705
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.
Results Reference
result
PubMed Identifier
26406203
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.
Results Reference
result

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The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain

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