Alternative and Integrative Therapy for Lumbar Disk Herniation

N/ACompletedNCT01989403

Jaseng Hospital of Korean Medicine128 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

128

Conditions

Sciatica Intervertebral Disc Disorder

Interventions

herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulationOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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;

Locations (1)

Jaseng Spine and joint Research Institute

Seoul, South Korea

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

Straight Leg Raise test

Time frame: 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.

Time frame: at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.

Data from ClinicalTrials.gov

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