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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: electric dry needling, manipulation; Other: conventional physical therapy

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Canton, Georgia, United States, 30114
      • Benchmark PT - Canton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: James Dunning, DPT, American Academy of Manipulative Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: AAMT0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No