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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167736
• Other study ID #: AAMT0011
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2024
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Benchmark PT - Canton	Canton	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Universidad Rey Juan Carlos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in Global Rating of Change Score		2-weeks, 6-weeks and 3-months
Secondary	Change in Medication Intake (Frequency of medication intake in last week)		baseline, 3 months