Clinical trial NCT03167736: Dry Needling and Spinal Manipulation vs. Conventional PT for Lumbar Spinal Stenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2017-05-30
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in low back pain (NPRS) (Rating Score)
timeFrame: baseline, 2-weeks, 6-weeks and 3-months
measure: Change in Oswestry Disability Index
timeFrame: baseline, 2-weeks, 6-weeks and 3-months
Secondary outcomes:
measure: Change in Roland Morris Disability Index
timeFrame: baseline, 2-weeks, 6-weeks and 3-months
measure: Change in Global Rating of Change Score
timeFrame: 2-weeks, 6-weeks and 3-months
measure: Change in Medication Intake (Frequency of medication intake in last week)
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Canton
country: United States
facility: Benchmark PT - Canton
state: Georgia
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT
role: PRINCIPAL_INVESTIGATOR
References: