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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: dry needling; Other: sham dry needling

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31905
    • Haifa University, Department of PHysical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Haifa
• Investigators: Principal Investigator: Gali Dar, PhD, Gali Dar, Department of Physical Therapy, University of Haifa

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: following study completion, a paper will be submitted to international professional journal
• IPD Sharing Time Frame: 6 months following end of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No