ClinicalTrials.Veeva

Menu

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

Emory University logo

Emory University

Status and phase

Completed
Phase 4

Conditions

Degenerative Disc Disease

Treatments

Procedure: Physical Therapy
Device: Accu-Spina Device/IDD therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00165893
0079-2004

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems