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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165893

Enrollment

Registered

2005-09-14

Start date

2004-09-30

Completion date

2006-11-30

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Keywords

low back pain, DDD

Brief 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.

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.

Interventions

DEVICEAccu-Spina Device/IDD therapy

PROCEDUREPhysical Therapy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026