Effectiveness of Mechanical Decompression for Low Back Pain Relief

NCT00704210 | Withdrawn

• 1 other identifier: IRBPHS 5379
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Pain will be measured using a 0-100 visual analog scale.

  19 weeks

• Functional activity will be measured using the Roland Morris activity scale

  19 weeks

• MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.

  19 weeks

Secondary Outcomes (5)

• Physical and social activities and quality of life will be measured with the COOP

  19 weeks

• Functional health will be measured with the SF-36

  19 weeks

• Depression will be measured using the Geriatric Depression Scale (GDS)

  19 weeks

• Treatment satisfaction will be measured using a 5-point Likert scale.

  19 weeks

• Reduction in pain medication usage

  19 weeks

Study Arms (2)

B

SHAM COMPARATOR

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.

Device: SpineMed Table, Cert HealthSciences LLC

A

EXPERIMENTAL

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.

Device: SpineMed Table, Cert HealthSciences LLC

Interventions

SpineMed Table, Cert HealthSciences LLC 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.

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William D Grant, EdD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Family Medicine

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 24, 2008
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2009
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

US (1)