Dry Needling to the Multifidus Muscle in Subjects With Low Back Pain

Study Overview
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Brief Summary
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To examine for differences in contraction thickness of the transversus abdominis muscle in symptomatic subjects with mechanical lower back pain following the application of dry needling to the lumbar multifidus muscles.

Detailed Description
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Consenting subjects will be pre-screened for contraindications for dry needling and whether or not they meet the criteria for low back pain. Following acceptance and prior to intervention sessions, subjects will complete a pre-participation questionnaire. This will be used to check for any needle phobia or previous adverse reactions to needling in prospective subjects and analyze potential confounding variables within the subjects participating. Once consented and accepted into the study, subjects will be taught the deep corset contraction (DCC), which is the isolated co-contraction of bilateral transversus abdominis and the deep fibers of lumbar multifidus. Following DCC training, the subject will have a real-time ultrasound transducer applied to the lateral abdominal wall in order to image the three abdominal muscle layers external oblique, internal oblique and transversus abdominis. A relaxed state measure will be taken from the ultrasound image. Subjects will then perform the DCC and a second measure of the abdominal muscles will be taken. A percentage thickness change will be calculated. Prior to treatment, subjects will have been randomly assigned to one of 2 intervention ordered groups: 1) Dry needling: subjects will be placed prone and dry needling to the bilateral multifidus muscles will be performed. Subjects will sense light pressure and their skin will be penetrated by the needle. 2) Sham needling: subjects will be placed prone and the plastic tubes which house the needles for dry needling will be pressed into the bilateral multifidus muscles.Subjects will sense light pressure, but their skin will not be penetrated. All needling and sham needling interventions will be performed under clean needle conditions using appropriate skin preparation and use of clean protective gloves by the PI. The needles used will be single-use disposable acupuncture-style needles which come in a plastic tube for easy insertion. Dry needling techniques are techniques that many practicing therapists use for various musculoskeletal conditions, and are also taught by the PI as part of the requirements for the Doctor of Physical Therapy degree. For this study, all needling and sham needling interventions will be performed by the PI who has over 27 years experience in such interventions. Immediately following the needling or sham needling, the real-time ultrasound will be reapplied to measure thickness of the abdominal muscles in the relaxed state and contracted state using the DCC, and percent changes will be calculated. Measurements will be collected by one of three independent researchers who will be blinded to the intervention. An average of 3 measurements will be used to calculate the percent thickness change after the treatment. In addition, the PI performing the needling will remain blinded to ultrasound measurements. Subjects will then be contacted by phone 48 hours as well as one week after the intervention was given in which they will verbally complete questionnaires regarding their degree of pain and level of disability.

Official Title
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The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Subjects With Low Back Pain

Conditions
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Low Back Pain, Mechanical

Intervention / Treatment
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* Procedure: Dry Needling
* Procedure: Sham Needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age, current symptoms of mechanical low back pain or any symptoms experienced within the last 6 months, and ability to perform DCC. Subjects must also report they are comfortable with being 'needled', that is, they should not express a fear of needles and being needled. If subjects express fear of needles or being needled, they will be excluded from the study. Exclusion Criteria: History of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis, anticoagulant therapy, hemophilia, lymphedema, and cancer. If a subject reports a fear of needles. History of adverse reaction to needling (or injection) in the past.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needling<br>Insertion of solid mono-filament needle into lumbar multifidus muscle at both sides of L4/5 segment | Procedure: Dry Needling<br> <br> |
| Other: Sham<br>The plastic tube containing the mono-filament needle will be pressed into the skin over the lumbar multifidus muscle at both sides of L4/5 segment - without insertion through the skin | Procedure: Sham Needling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters | Using real-time ultrasound imaging to measure thickness in milimeters | Immediate | 
| Contracted thickness transversus abdominis Using real-time ultrasound imaging to measure thickness in milimeters | Using real-time ultrasound imaging to measure thickness in milimeters | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale 10 point pain scale | 10 point pain scale | Immediate and 48 hours later | 
| Oswestry Disability Index | Patient reported outcome measure | 48 hours later |