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NCT Number: NCT03167736

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

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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benchmark PT - Canton

Canton, Georgia, 30114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electric dry needling, manipulation

Other

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

Other

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 outcomes

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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Roland Morris Disability Index

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 30, 2017
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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