Lumbar Disc Herniation Clinical Trial
Official title:
Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
NCT number | NCT03118271 |
Other study ID # | 20160806R |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | December 2019 |
Verified date | April 2018 |
Source | Shin Kong Wu Ho-Su Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in the treatment of LDH.
Status | Terminated |
Enrollment | 60 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | ShinKongHospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Global impression of change | contains seven items from "very much improved" to "very much worse" | Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. | |
Secondary | Modified Oswestry Disability Questionnaire (MODQ) | 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. | Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. | |
Secondary | SF-36 | 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. | Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments. |
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