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CompletedNCT03167736Updated Jun 12, 2024

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

An interventional study of electric dry needling, manipulation and conventional physical therapy in Lumbar Spinal Stenosis, sponsored by Alabama Physical Therapy & Acupuncture. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Alabama Physical Therapy & Acupuncture · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Lumbar Spinal Stenosis
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Electric dry needling, manipulation

    Other: electric dry needling, manipulation

  • Active comparator
    conventional physical therapy

    Other: conventional physical therapy

Interventions

  • Otherelectric 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.

  • Otherconventional 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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: baseline, 2-weeks, 6-weeks and 3-months

  2. 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.

    Time frame: baseline, 2-weeks, 6-weeks and 3-months

Secondary outcomes

  1. Change in Roland Morris Disability Index

    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

  2. Change in Global Rating of Change Score

    Time frame: 2-weeks, 6-weeks and 3-months

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

    Time frame: baseline, 3 months

06

Study locations

1 site
  • Benchmark PT - Canton
    Canton, Georgia 30114, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03167736
Lead sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Universidad Rey Juan Carlos
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) — Principal investigator
First posted
May 30, 2017
Start date
Jun 15, 2017
Primary completion
Mar 15, 2020
Completion
Mar 15, 2020
Last update
Jun 12, 2024

Study contacts

James Dunning, DPT
principal investigator · American Academy of Manipulative Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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