Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis

NCT03118206 | Terminated DMC

• 1 other identifier: 20160804R
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.

Conditions

Lumbar Spinal Stenosis; Spinal Manipulation; Physical Therapy; Surgery

Keywords

Lumbar spinal stenosis; spinal manipulation; physical therapy; surgery

Outcome Measures

Primary Outcomes (1)

• VAS pain score

  an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.

Secondary Outcomes (4)

• Modified OswestryDisability Questionnaire (MODQ)

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.

• Swiss Spinal Stenosis Questionnaire

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.

• The Medical Outcome Survey Short Form (SF-36)

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.

• Intermittent claudication

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.

Study Arms (3)

Lumbar spinal manipulation

ACTIVE COMPARATOR

Lumbar spinal manipulation will be performed up to 8 times within 1 month (no more than 2 times per week) by Dr. WangTso-Liang, who is a well-trained and experienced manual therapy doctor. If the symptoms subside before the end of 1 month' treatment, the manipulation is discontinued.

Device: lumbar traction

Physical therapy

ACTIVE COMPARATOR

Physical therapy will include treatment with therapeutic exercise and modalities (lumbar traction, heattherapy, electric stimulation, and therapeutic exercise) for 2 month with frequency 3 times per week.

Procedure: spinal manipulation

Surgery

ACTIVE COMPARATOR

General anesthesia, the patient will be put in the prone and abdomen-free position. A 4-cm midline longitudinal incision will be made over the spinous processes of the L3-5 levels. It will be deepened through the fat and fascia in line with the skin incision to reach the spinous processes.The paraspinous muscles will be dissected subperiosteally down the spinous processes and along the lamina to the facet joints. Laminectomy will be done carefully at the herniated disc level for posterior decompression. The ligamentum flavum will be excised to expose the dural sac.Using blunt dissection, the investigators carefully continue down the lateral side of the dura to the floor of the spinal canal; the investigators retract the dura and its nerve root medially. After the posterior aspect of the disc space is revealed, the affected disc will be removed and discotomy will be performed.The wound will be closed in the routine fashion after meticulous hemostasis and normal saline irrigation.

Procedure: surgery

Interventions

lumbar traction DEVICE

Lumbar spinal manipulation

spinal manipulation PROCEDURE

Physical therapy

surgery PROCEDURE

Surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 to 80 age years old
• Moderate to severe low back painand/or sciatica,and/or intermittent claudication (VAS\>=4)
• Symptom duration is more than three months
• The diagnosis is proved by MRI

You may not qualify if:

• Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
• Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
• Concomitant serious medical conditions
• History of spinal surgery before
• Severe osteoporosis or instability of the lumbar spine

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

ShinKongHospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Manipulation, Spinal; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Lin-Fen Hsieh, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 18, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

TW (1)