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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498572
• Other study ID #: 2393
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2021
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• dry needling
dry needling for Gluteus Medius muscle in combination with exercises
• sham dry needling
sham dry needling for Gluteus Medius muscle in combination with exercises

Locations

Country	Name	City	State
Israel	Haifa University, Department of PHysical Therapy	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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/s00586-015-4 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Global rating of change	a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.	3 weeks
Secondary	Change in hip abductors muscle strength	muscle strength in Newton, assessed by an hand held dynamometer	baseline and 3 weeks
Secondary	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