Effectiveness of Mechanical Decompression for Low Back Pain Relief (SpiDERS)

This study has been withdrawn prior to enrollment.
(Study withdrawn by sponsor)
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00704210
First received: June 20, 2008
Last updated: April 26, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Low Back Pain
Device: SpineMed Table, Cert HealthSciences LLC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effectiveness of Mechanical Decompression for Low Back Pain Relief

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Pain will be measured using a 0-100 visual analog scale. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Functional activity will be measured using the Roland Morris activity scale [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical and social activities and quality of life will be measured with the COOP [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Functional health will be measured with the SF-36 [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Depression will be measured using the Geriatric Depression Scale (GDS) [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Treatment satisfaction will be measured using a 5-point Likert scale. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Reduction in pain medication usage [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: August 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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.
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.
Experimental: 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.
Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704210

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: William D Grant, EdD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: William D. Grant, EdD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00704210     History of Changes
Other Study ID Numbers: IRBPHS 5379
Study First Received: June 20, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Low Back Pain

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014