NCT04498572

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

April 22, 2024

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

July 27, 2020

Last Update Submit

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

EXPERIMENTAL

active exercises and dry needling for the Gluteus medius muscle

Other: dry needling

control group

SHAM COMPARATOR

active exercises and sham dry needling for the Gluteus medius muscle

Other: sham dry needling

Interventions

dry needling for Gluteus Medius muscle in combination with exercises

research group

sham dry needling for Gluteus Medius muscle in combination with exercises

control group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

  • Dar 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.

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Gali Dar, PhD

    Gali Dar, Department of Physical Therapy, University of Haifa

    PRINCIPAL INVESTIGATOR

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
Model Details: two groups. research group will receive dry needling and control group will receive sham dry needling.
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

following study completion, a paper will be submitted to international professional journal

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months following end of study

Locations