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

Sponsor
Alabama Physical Therapy & Acupuncture (Other)
Overall Status
Completed
CT.gov ID
NCT03167736
Collaborator
Universidad Rey Juan Carlos (Other)
135
1
2
33
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: electric dry needling, manipulation
  • Other: conventional physical therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 15, 2017
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electric dry needling, manipulation

Other: electric dry needling, manipulation
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.

Active Comparator: conventional physical therapy

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. Change in Global Rating of Change Score [2-weeks, 6-weeks and 3-months]

  3. Change in Medication Intake (Frequency of medication intake in last week) [baseline, 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Benchmark PT - Canton Canton Georgia United States 30114

Sponsors and Collaborators

  • Alabama Physical Therapy & Acupuncture
  • Universidad Rey Juan Carlos

Investigators

  • Principal Investigator: James Dunning, DPT, American Academy of Manipulative Therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Dunning, DPT, MSc, FAAOMPT, Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy, Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier:
NCT03167736
Other Study ID Numbers:
  • AAMT0011
First Posted:
May 30, 2017
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2020