The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Visual analogue scale for low back and leg pain
Study Overview
Brief Summary
The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •LBP with sciatica,
- •A numeral rating scale (NRS) leg pain intensity of 5 or higher
- •Onset within 1 year;
- •Lumbar Disk Heriation confirmed by MRI;
- •Written consent to attend 6 months of integrative CAM treatment and following assessment visits.
Exclusion Criteria
- •Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol
- •Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)
- •History of spinal surgery, vertebral dislocation, fracture, or cancer;
Outcomes
Primary Outcomes
Visual analogue scale for low back and leg pain
Time Frame: Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the Oswestry Disability Index
Time Frame: Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the SF-36 Health Survey
Time Frame: Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Secondary Outcomes
- Adverse events(at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.)
- Straight Leg Raise test(Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.)