Alternative and Integrative Therapy for Lumbar Disk Herniation

Completed

• Conditions: Sciatica; Intervertebral Disc Disorder
• Interventions: Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation

• Registration Number: NCT01989403
• Lead Sponsor: Jaseng Hospital of Korean Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-21
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar disc herniation patients	herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Jaseng Spine and joint Research Institute; 🇰🇷 Seoul, Korea, Republic of