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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: dry needling
* Other: sham dry needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups. research group will receive dry needling and control group will receive sham dry needling.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: research group<br>active exercises and dry needling for the Gluteus medius muscle | Other: dry needling<br>* dry needling for Gluteus Medius muscle in combination with exercises<br>|
| Sham Comparator: control group<br>active exercises and sham dry needling for the Gluteus medius muscle | Other: sham dry needling<br>* sham dry needling for Gluteus Medius muscle in combination with exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and at 3 weeks | 
| 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. | baseline and at 3 weeks | 
| Global rating of change | a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hip abductors muscle strength | muscle strength in Newton, assessed by an hand held dynamometer | baseline and 3 weeks | 
| Change in lumbar flexion range of motion | lumbar flexion assessment by bending forward and measuring distance of fingers from the floor | baseline and 3 weeks |