Intervertebral Disc Disorder, Sciatica
Conditions
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.
Interventions
OTHERherbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation
Sponsors
Jaseng Hospital of Korean Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale for low back and leg pain | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| Adverse events | at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years. | Skin and general reactions, aggravation or change in pain before and after acupuncture, pharmacoacupuncture, and Chuna manipulation treatment were observed. Regular blood tests (blood cell count, liver, renal function tests, inflammatory activity indexes) were administered. |
Countries
South Korea
Outcome results
None listed