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

NCT03167736 | Completed

• 1 other identifier: AAMT0011
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Roland Morris Disability Index

  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

Study Arms (2)

Electric dry needling, manipulation

EXPERIMENTAL

Other: electric dry needling, manipulation

conventional physical therapy

ACTIVE COMPARATOR

Other: conventional physical therapy

Interventions

electric dry needling, manipulation OTHER

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.

Electric dry needling, manipulation

conventional physical therapy OTHER

Impairment-based manual therapy, stretching, strengthening and electrothermal modalities targeting the lumbar/sacral spine and hips. Up to 12 treatment sessions over 6 weeks.

conventional physical therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Benchmark PT - Canton

Canton, Georgia, 30114, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• James Dunning, DPT

  American Academy of Manipulative Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 15, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

US (1)