Low Back PainNCT04498572
The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain
A study testing dry needling in people with Low Back Pain, run by University of Haifa at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2020to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Main complaint of nonspecific LBP over a 3 month period
- VAS > 3 at baseline
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- dry needling, sham dry needling
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
dry needling for Gluteus Medius muscle in combination with exercises
sham dry needlingOther
sham dry needling for Gluteus Medius muscle in combination with exercises
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | active exercises and dry needling for the Gluteus medius muscle Receives: Other: dry needling |
| control group | Sham comparator | active exercises and sham dry needling for the Gluteus medius muscle Receives: Other: sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (2)
Change in hip abductors muscle strength
muscle strength in Newton, assessed by an hand held dynamometer
Measured: 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
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Oct 2020
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups. research group will receive dry needling and control group will receive sham dry needling.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gali Dar, PhD, Principal investigator, Gali Dar, Department of Physical Therapy, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498572
- Sponsor's protocol ID
- 2393
- Status last verified
- Oct 2021
- First submitted
- 27 Jul 2020
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following study completion, a paper will be submitted to international professional journal
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.
PubMed 26006705Dar 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.
PubMed 26406203Dar 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.
PubMed 39954045
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498572
- Acronym / sponsor ID
- 2393
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups. research group will receive dry needling and control group will receive sham dry needling.
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Other: dry needlingactive exercises and dry needling for the Gluteus medius muscle |
| control group | Sham comparator | Other: sham dry needlingactive exercises and sham dry needling for the Gluteus medius muscle |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Main complaint of nonspecific LBP over a 3 month period
- VAS > 3 at baseline
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingdry needling for Gluteus Medius muscle in combination with exercises | Other | research group |
| sham dry needlingsham dry needling for Gluteus Medius muscle in combination with exercises | Other | control group |
Primary outcome
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.
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.
Global rating of change
Time frame: 3 weeks
a 15-point Likert scale ranging to assess treatment success. Higher scores mean a better outcome.
2 secondary outcomes
Change in hip abductors muscle strength
Time frame: baseline and 3 weeks
Change in lumbar flexion range of motion
Time frame: baseline and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Results publication: PubMed 26006705Cooper 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.
- Results publication: PubMed 26406203Dar 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.
- Derived from this study: PubMed 39954045Dar 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.
- Individual participant dataSharing planned: Yes. following study completion, a paper will be submitted to international professional journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gali Dar, PhD principal investigator
Gali Dar, Department of Physical Therapy, University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling in people with Low Back Pain, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in visual analog scale (VAS) (time frame: baseline and at 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498572, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.