- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250742
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
The study will establish data on the function of trunk muscles in healthy and low back pain patient's pre and post dry needling treatment. This will help in understanding the underlying mechanism of this treatment and reveal the effect of dry needling on muscle performance.
Study hypothesis is that an improvement of back muscle function following dry needling procedure will be found.
Study Overview
Detailed Description
Dry needling of muscles is mainly used for the management of pain in musculoskeletal disorders. Yet, the association between dry needling and motor performance of muscles is still unclear.
This study aims to investigate the immediate effect of dry needling on lumbar multifidus muscles' function in healthy and low back pain subjects.
The sample will be divided into: low back pain group and control (healthy) group. Both groups will receive dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine). The needles will be left in situ for 10 minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and post- procedure during rest in a prone position and during contralateral active straight leg extension.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haifa, Israel
- University of Haifa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-60 years.
- Healthy individuals or individuals with main complaint of low back pain (LBP)
Exclusion Criteria:
- Patients with "red flags" for a serious spinal condition, for example: tumor, compression fractures, infection, cancer.
- Signs of nerve root compression (positive straight leg raise <45 degrees, decreased reflexes, decrease sensation or decreased strength in the lower extremities).
- Pregnancy.
- Previous surgery to the lumbar spine
- History of congenital lumbar or pelvic anomalies
- Physical therapy for LBP was provided in the 6 months prior to participation in the study
- Patients who are unable to lie prone for 30 minutes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low back pain group
Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utielized.
The needles will be left in situ for 10 minutes.
|
Dry needling uses traditional acupuncture needles without injecting any liquid.
Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.
Other Names:
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Active Comparator: healthy group
Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utilized.
The needles will be left in situ for 10 minutes.
|
Dry needling uses traditional acupuncture needles without injecting any liquid.
Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Multifidus muscle thickness
Time Frame: baseline and Immediately after dry needling procedure at the same session
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Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
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baseline and Immediately after dry needling procedure at the same session
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gali Dar, PhD, University of Haifa, Department of Physical Therapy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 045/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
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