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

Primary Purpose

Lumbar Spinal Stenosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

electric dry needling, manipulation

conventional physical therapy

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Benchmark PT - Canton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electric dry needling, manipulation

conventional physical therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in low back pain (NPRS) (Rating Score)

Baseline score must exceed 2/10 to be included in the study.

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.

Secondary Outcome Measures

Change in Roland Morris Disability Index

The Roland Morris Disability Index (RMDI) is measured on a 0-24 scale. Greater scores indicate increased disability.

Change in Global Rating of Change Score

Change in Medication Intake (Frequency of medication intake in last week)

Full Information

NCT ID

NCT03167736

First Posted

May 24, 2017

Last Updated

December 28, 2020

Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT03167736

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

June 15, 2017 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alabama Physical Therapy & Acupuncture

Collaborators

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electric dry needling, manipulation

Arm Type

Experimental

Arm Title

conventional physical therapy

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

electric dry needling, manipulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

conventional physical therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in low back pain (NPRS) (Rating Score)

Description

Baseline score must exceed 2/10 to be included in the study.

Time Frame

baseline, 2-weeks, 6-weeks and 3-months

Title

Change in Oswestry Disability Index

Description

Time Frame

baseline, 2-weeks, 6-weeks and 3-months

Secondary Outcome Measure Information:

Title

Change in Roland Morris Disability Index

Description

The Roland Morris Disability Index (RMDI) is measured on a 0-24 scale. Greater scores indicate increased disability.

Time Frame

baseline, 2-weeks, 6-weeks and 3-months

Title

Change in Global Rating of Change Score

Time Frame

2-weeks, 6-weeks and 3-months

Title

Change in Medication Intake (Frequency of medication intake in last week)

Time Frame

baseline, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Dunning, DPT

Organizational Affiliation

American Academy of Manipulative Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benchmark PT - Canton

City

Canton

State/Province

Georgia

ZIP/Postal Code

30114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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