Dry Needling and Spinal Manipulation vs. Conventional PT for Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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The purpose of this research is to compare two different approaches for treating patients with lumbar spinal stenosis: electric dry needling and thrust manipulation versus impairment-based manual therapy, stretching, strengthening and electrothermal modalities. Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed Description
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Patients with lumbar spinal stenosis will be randomized to receive 1-2 treatment sessions per week for 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and thrust manipulation or (2) impairment-based manual therapy, stretching, strengthening and electrothermal modalities

Official Title
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The Addition of Electric Dry Needling and Spinal Manipulation to Impairment-based Manual Therapy, Stretching, Strengthening and Electrothermal Modalities for Patients With Lumbar Spinal Stenosis: a Multi-randomized Clinical Trial

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Other: electric dry needling, manipulation
* Other: conventional physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult over the age of 50 years old that is able to read, write and speak English Symptoms of neurogenic claudication (pain in the buttock, thigh, or leg during ambulation that improves with rest) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks. Confirmatory imaging (i.e. magnetic resonance imaging (MRI), computed tomography (CT), myelography, ultrasound or X-ray of either central or lateral (foraminal) lumbar spinal stenosis at one or more levels in the lumbar spine. Exclusion Criteria: Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc. Severe vascular, pulmonary, or coronary artery disease limiting participation in exercise, to include a walking program (including presence of absolute contraindications to submaximal exercise testing) Severe degenerative stenosis with intractable pain and progressive neurological dysfunction Lumbar spinal stenosis not caused by degeneration Radiographic evidence of instability, degenerative spondylolisthesis, fracture or scoliosis of more than 15° Lumbar herniated disc diagnosis during the last 12 months. Previous lumbar surgery for lumbar spinal stenosis or instability (i.e. previous lumbar fusion, lumbar microdiscectomy, lumbar foraminotomy, lumbar laminectomy, etc.) Psychiatric disorder or cognitively impaired. Pregnancy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric dry needling, manipulation<br> | Other: electric dry needling, manipulation<br>* HVLA thrust manipulation to lumbar spine. Dry needling to lumbar/sacral paraspinal muscles and gluteus medium/minimus muscles. Treatment may include dry needling of the piriformis muscle, quadrates lumborum muscle and perineurial needling of sciatic/tibial nerve. Up to 12 treatment sessions over 6 weeks.<br>|
| Active Comparator: conventional physical therapy<br> | Other: conventional physical therapy<br>* Impairment-based manual therapy, stretching, strengthening and electrothermal modalities targeting the lumbar/sacral spine and hips. Up to 12 treatment sessions over 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in low back pain (NPRS) (Rating Score) | Baseline score must exceed 2/10 to be included in the study. | baseline, 2-weeks, 6-weeks and 3-months | 
| Change in Oswestry Disability Index | The Oswestry Disability Index (ODI) includes 10 questions, each worth 0-5 points with maximum score of 50 points possible. The greater the score, the worse the disability. Baseline score must exceed 10/50 points to be included in the study. | baseline, 2-weeks, 6-weeks and 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Roland Morris Disability Index | The Roland Morris Disability Index (RMDI) is measured on a 0-24 scale. Greater scores indicate increased disability. | baseline, 2-weeks, 6-weeks and 3-months | 
| Change in Global Rating of Change Score |  | 2-weeks, 6-weeks and 3-months | 
| Change in Medication Intake (Frequency of medication intake in last week) |  | baseline, 3 months |