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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Haifa
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Global rating of change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
participants will not be aware of the group they were assigned
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
research group
active exercises and dry needling for the Gluteus medius muscle
Intervention: dry needling (Other)
control group
active exercises and sham dry needling for the Gluteus medius muscle
Intervention: sham dry needling (Other)
Outcomes
Primary Outcomes
Global rating of change
Time Frame: 3 weeks
a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.
change in visual analog scale (VAS)
Time Frame: baseline and at 3 weeks
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
Time Frame: baseline and at 3 weeks
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.
Secondary Outcomes
- Change in hip abductors muscle strength(baseline and 3 weeks)
- Change in lumbar flexion range of motion(baseline and 3 weeks)