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

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ClinicalTrials.gov Identifier: NCT03118271
Recruitment Status : Terminated (Two authors changed their jobs.)
First Posted : April 18, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Lumbar Traction Spinal Manipulation Lumbar Surgery Device: lumbar traction Procedure: spinal manipulation Procedure: surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: lumbar traction
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
Active Comparator: spinal manipulation
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
Active Comparator: surgery
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



Primary Outcome Measures :
  1. VAS pain score [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. ]
    an 10-cm horizontal line will be used to assess average pain intensity in the last 1 week


Secondary Outcome Measures :
  1. Global impression of change [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. ]
    contains seven items from "very much improved" to "very much worse"

  2. Modified Oswestry Disability Questionnaire (MODQ) [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. ]
    For evaluation of disability related to LBP, Oswestry Disability Questionnaire (ODQ) is most widely used. ODQ is a 10-item self report instrument that evaluates perceived disability in 10 areas: pain intensity, ability to lift objects, ability to walk, ability to sit, ability to stand, ability to sleep, sex life, social life, traveling, and ability to complete personal hygiene activities. By using a 6-point Likert scale (0 = no limitation; 5 = severe limitation) , the total maximum scale is doubled and reported as a percentage of the patients perceived pain-related disability, with higher scores indicating greater disability. Because sex life could be an embarrassing issue in Chinese society, the investigators prefer to use modified or revised ODQ or MODQ,30,31 in which sex life is replaced by employment or homemaking. High validity and reliability of MODQ for LDH and LBP has been studied previously.

  3. SF-36 [ Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. ]
    The Medical Outcome Survey Short Form (SF-36) was used to assesses general health status. The SF-36 measures eight dimensions of health: general health perceptions, physical function, physical role, bodily pain, social functioning, mental health, emotional role, and vitality. The eight scales may be combined into two summary scores, the physical component summary (PCS) and the mental component summary (MCS). The SF-36 has well-established psychometric properties for the general population and individuals with LBP.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118271


Locations
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Taiwan
ShinKongHospital
Taipei, Taiwan
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
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Principal Investigator: Lin-Fen Hsieh, M.D Shin Kong Wu Ho-Su Memorial Hospital
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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT03118271    
Other Study ID Numbers: 20160806R
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
lumbar disc herniation
lumbar traction
spinal manipulation
lumbar surgery
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical