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OpenTrials
Completed

NCT Number: NCT00165893

Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease

This study is looking at a new machine called the Accu-Spina which administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.

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Key information

Conditions

Degenerative Disc Disease Back Pain Bone Diseases Intervertebral Disc Degeneration Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This study is a randomized trial where out of every 3 people, 2 will receive IDD therapy and 1 will have standardized physical therapy. Patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. If at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic low back pain for > 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies
  • Over 18 years old
  • Able to provide written informed consent

Exclusion criteria

  • Infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system
  • Evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc
  • Uncontrolled mood disorder
  • History of drug or substance abuse
  • Lumbar spine pathology requiring surgical intervention
  • Previous spine surgery of the lumbar spine, except discectomies >12 months
  • Improvement with similar non-surgical treatments in the last 3 months
  • Active litigation, workers compensation
  • Females whom are pregnant

Treatment and study plan

Accu-Spina Device/IDD therapy

Device

physical therapy

Procedure

Primary outcomes

  1. Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.

Secondary outcomes

  1. Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • North American Medical Corporation

Registry information

Official study title

Comparison of Internal Disc Decompression (IDD) vs. a Standardized Non-surgical Treatment Program for Chronic Low Back Pain Secondary to Mild to Moderate Degenerative Disc Disease (DDD)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 24, 2013

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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