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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Degenerative Disc Disease

Keywords

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low back pain DDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Accu-Spina Device/IDD therapy

Intervention Type DEVICE

Physical Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kyle Webb

Research Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael K Schaufele, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Countries

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United States

Other Identifiers

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0079-2004

Identifier Type: -

Identifier Source: org_study_id