Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation

NCT03118271 | Terminated DMC

• 1 other identifier: 20160806R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in the treatment of LDH.

Conditions

Lumbar Disc Herniation; Lumbar Traction; Spinal Manipulation; Lumbar Surgery

Keywords

lumbar disc herniation; lumbar traction; spinal manipulation; lumbar 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 and post-treatment 2 months after treatments.

Secondary Outcomes (3)

• Global impression of change

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.

• Modified Oswestry Disability Questionnaire (MODQ)

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.

• SF-36

  Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.

Study Arms (3)

lumbar traction

ACTIVE COMPARATOR

Treatment with lumbar traction is via an OPD base. It comprised a 20 min. treatment session over a period of 2 months. If the symptoms subside before the end of 2 months' treatment, lumbar traction will be discontinued, and the treatment duration and number of treatment session will be recorded. The frequency of treatment is 3 times per week. Treatment method is according to the common clinical guidelines, starting from 25% of the subject's body weight and steadily increasing to 50% of body weight. Before traction, heat therapy will be applied to the low back of the subject, and electric therapy will also be given to the painful areas. The treatment will be conducted by the same physiotherapist.

Device: lumbar traction

spinal manipulation

ACTIVE COMPARATOR

Spinal manipulation will be performed by a spinal manipulator (Dr. Tso-Liang Wang) who was graduated from Los Angeles College of Chiropractic. Before performing spinal manipulation, he will exam the patient's whole body throughly, especially focusing on the lumbo-pelvic-hip region. What he exams includes pelvic and spinal alignment, tension of soft tissues, tissue texture, joint mobility, movement patterns, and muscle power. The manipulation is started with release of the hypertonic myofascial structures and thus normalize the myofascial tension of the lumbo-pelvic-hip region. Then he will align the lumbar spine, pelvis and hip joint three-dimensionally according to the findings of his examination on the same day. The manipulation will be performed up to 8 times within one month (no more than 2 manipulations a week). If the symptoms subside before the end of one-month' treatment, the manipulation is discontinued and the number of treatment session will be recorded.

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 traction

spinal manipulation PROCEDURE

spinal manipulation

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\>20 and less than 80 y/o with LDH with moderate to severe (VAS pain \> 4) LBP and/or sciatica. LDH should be proved by MRI of the lumbosacral spine. The duration of pain is less than 1 month.

You may not qualify if:

• LBP probable due to serious spinal pathology such as spinal tumor, infection, and inflammatory disease such as ankylosing spondylitis.28
• LDH with progressive weakness in the lower extremities or symptoms and signs suggesting cauda equina lesion.
• Concomitant serious medical conditions.
• History of spinal surgery before.
• Severe osteoporosis or image studies suggesting instability of the lumbosacral spine.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

ShinKongHospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Manipulation, Spinal; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: 2018-04

Locations

TW (1)