Alternative and Integrative Therapy for Lumbar Disk Herniation

Sciatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989403
• Other study ID #: JS-CT-2011-03
• Status: Completed
• Start date: February 2006
• Est. completion date: March 2013

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Disorder
• Intervertebral Disc Displacement
• Sciatica

Intervention

Other:
• herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Spine and joint Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.