Clinical trial NCT04498572: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups. research group will receive dry needling and control group will receive sham dry needling.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in visual analog scale (VAS)
timeFrame: baseline and at 3 weeks
measure: Change in Modified Oswestry Disability Index
timeFrame: baseline and at 3 weeks
measure: Global rating of change
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in hip abductors muscle strength
timeFrame: baseline and 3 weeks
measure: Change in lumbar flexion range of motion
timeFrame: baseline and 3 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Haifa University, Department of PHysical Therapy
Study officials:
affiliation: Gali Dar, Department of Physical Therapy, University of Haifa
name: Gali Dar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.