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

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: electric dry needling, manipulation; Other: conventional physical therapy

• Registration Number: NCT03167736
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Study Start: 2017-06-15
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Adult over the age of 50 years old that is able to read, write and speak English
2. 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.
3. 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

1. 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.
2. 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)
3. Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
4. Lumbar spinal stenosis not caused by degeneration
5. Radiographic evidence of instability, degenerative spondylolisthesis, fracture or scoliosis of more than 15°
6. Lumbar herniated disc diagnosis during the last 12 months.
7. Previous lumbar surgery for lumbar spinal stenosis or instability (i.e. previous lumbar fusion, lumbar microdiscectomy, lumbar foraminotomy, lumbar laminectomy, etc.)
8. Psychiatric disorder or cognitively impaired.
9. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric dry needling, manipulation	electric dry needling, manipulation	-
conventional physical therapy	conventional physical therapy	-

Primary Outcome Measures

Name	Time	Method
Change in low back pain (NPRS) (Rating Score)	baseline, 2-weeks, 6-weeks and 3-months	Baseline score must exceed 2/10 to be included in the study.
Change in Oswestry Disability Index	baseline, 2-weeks, 6-weeks and 3-months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Benchmark PT - Canton; 🇺🇸 Canton, Georgia, United States