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Completed

NCT Number: NCT04498572

The Effect of Dry Needling of the Gluteus Medius Muscle 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haifa University, Department of PHysical Therapy

Haifa, 31905, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Other

dry needling for Gluteus Medius muscle in combination with exercises

Sham dry needling

Other

sham dry needling for Gluteus Medius muscle in combination with exercises

Primary outcomes

  1. change in visual analog scale (VAS)

    Time frame: baseline and at 3 weeks

    assessing pain on a scale from 0 (no pain) to 10 (most sever pain). Higher scores means worse outcome.

  2. Change in Modified Oswestry Disability Index

    Time frame: baseline and at 3 weeks

    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.

  3. Global rating of change

    Time frame: 3 weeks

    a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.

Secondary outcomes

  1. Change in hip abductors muscle strength

    Time frame: baseline and 3 weeks

    muscle strength in Newton, assessed by an hand held dynamometer

  2. Change in lumbar flexion range of motion

    Time frame: baseline and 3 weeks

    lumbar flexion assessment by bending forward and measuring distance of fingers from the floor

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2020
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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