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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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"
- 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.
- 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.
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
|Principal Investigator:||Lin-Fen Hsieh, M.D||Shin Kong Wu Ho-Su Memorial Hospital|