Alternative and Integrative Therapy for Lumbar Disk Herniation

NCT01989403 | Completed DMC

• 1 other identifier: JS-CT-2011-03
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica; Intervertebral Disc Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

Study Arms (1)

Lumbar disc herniation patients

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

Interventions

herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation OTHER

Lumbar disc herniation patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

integrative hospital that offers both Western and traditional Korean medical services

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Spine and joint Research Institute

Seoul, 135-896, South Korea

Location

MeSH Terms

Conditions

Sciatica; Intervertebral disc disease

Interventions

Phytotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 21, 2013
• Study Start: February 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (1)