Effectiveness of Mechanical Decompression for Low Back Pain Relief

NCT ID: NCT00704210

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-07-31

Brief Summary

Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.

Detailed Description

Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.

The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed

Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.

To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.

To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.

To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

B

Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.

Group Type: SHAM_COMPARATOR

SpineMed Table, Cert HealthSciences LLC

Intervention Type: DEVICE

Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.

A

For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.

Group Type: EXPERIMENTAL

SpineMed Table, Cert HealthSciences LLC

Intervention Type: DEVICE

For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.

Interventions

SpineMed Table, Cert HealthSciences LLC

For Group A (the treated group) the following tension adjustments will be used: starting treatment tension will equal 1/4 body weight minus 10 lbs. Incremental increases of 4 lbs. per session will be implemented until optimum tensions are reached, which would be a maximum of ¼ body weight plus 25 lbs, unless distraction tensions cause discomfort, which would require a reduction of the tensions applied.

Intervention Type: DEVICE

SpineMed Table, Cert HealthSciences LLC

Group B will receive sham decompression treatment (i.e. tension not exceeding 15 lbs) for 30 minutes and ice treatment for 15 minutes once a day during each treatment session. No incremental increases will be used for Group B.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities,
• Applicants may have pain radiating to their legs.

Exclusion Criteria

• Any episode of Acute LBP within the last 6 weeks or less
• Recent Fractures, less than 8 weeks of any bone
• Tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type
• Gross osteoporosis,
• Spondylolisthesis grade 2 and above,
• Hardware fixation, spine fixation or other boney fusion
• Obesity as defined by a BMI greater than 35, body weight over 287 pounds,
• Contra-indication for MRJ assessment,
• Pregnancy,
• neurologic deficits,
• bowel or bladder incontinence,
• progressive lower extremity weakness,
• need for narcotic pain medications for other conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

William Grant

Professor, Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William D Grant, EdD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

IRBPHS 5379

Identifier Type: -

Identifier Source: org_study_id