Alternative and Integrative Therapy for Lumbar Disk Herniation

Study Overview
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Brief Summary
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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.

Official Title
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The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study

Conditions
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Sciatica, Intervertebral Disc Disorder

Intervention / Treatment
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* Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar disc herniation patients<br>LBP with sciatica, with a numeral rating scale (NRS) leg pain intensity of 5 or higher and onset within 1 year; (2) LDH confirmed by MRI | Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years. |