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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Oct 2020
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedApril 22, 2024
October 1, 2021
1.8 years
July 27, 2020
April 19, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Change in hip abductors muscle strength
baseline and 3 weeks
Change in lumbar flexion range of motion
baseline and 3 weeks
Study Arms (2)
research group
EXPERIMENTALactive exercises and dry needling for the Gluteus medius muscle
control group
SHAM COMPARATORactive exercises and sham dry needling for the Gluteus medius muscle
Interventions
sham dry needling for Gluteus Medius muscle in combination with exercises
Eligibility Criteria
You may qualify if:
- Main complaint of nonspecific LBP over a 3 month period
- VAS \> 3 at baseline
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haifa University, Department of PHysical Therapy
Haifa, 31905, Israel
Related Publications (3)
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.
PMID: 26006705RESULTDar 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.
PMID: 26406203RESULTDar G, Goldberg A. Dry needling of the gluteus-medius muscle, combined with standard care, for chronic low back pain - a pilot randomized sham-controlled trial. J Man Manip Ther. 2025 Oct;33(5):392-400. doi: 10.1080/10669817.2025.2465726. Epub 2025 Feb 15.
PMID: 39954045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gali Dar, PhD
Gali Dar, Department of Physical Therapy, University of Haifa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- participants will not be aware of the group they were assigned
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2020
First Posted
August 4, 2020
Study Start
October 1, 2020
Primary Completion
July 15, 2022
Study Completion
July 15, 2022
Last Updated
April 22, 2024
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 6 months following end of study
following study completion, a paper will be submitted to international professional journal