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OpenTrials
Completed

NCT Number: NCT01989403

Alternative and Integrative Therapy for Lumbar Disk Herniation

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.

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Key information

Conditions

Sciatica Intervertebral Disc Disorder Intervertebral disc disease Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Spine and joint Research Institute

Seoul, 135-896, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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