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CompletedNCT00165893Updated Dec 24, 2013

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

A Phase 4 interventional study of Accu-Spina Device/IDD therapy and Physical Therapy in Degenerative Disc Disease, sponsored by Emory University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-24.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed 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.

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Conditions studied

  • Degenerative Disc Disease

Keywords

  • low back pain
  • DDD
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In context

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 166 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants

Interventions

  • DeviceAccu-Spina Device/IDD therapy
  • ProcedurePhysical Therapy
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What researchers measure

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.

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00165893
Lead sponsor
Emory University
Collaborators
North American Medical Corporation
Responsible party
Kyle Webb (Research Administrator, Emory University) — Principal investigator
First posted
Sep 14, 2005
Start date
Sep 2004
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Dec 24, 2013

Study contacts

Michael K Schaufele, M.D.
principal investigator · Emory University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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