Clinical trial NCT00704210: Effectiveness of Mechanical Decompression for Low Back Pain Relief
Official title: Effectiveness of Mechanical Decompression for Low Back Pain Relief
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain will be measured using a 0-100 visual analog scale.
timeFrame: 19 weeks
measure: Functional activity will be measured using the Roland Morris activity scale
timeFrame: 19 weeks
measure: MRI outcome measures include thickness of disc (disc height, intervertebral space), extent of disc bulging, intervertebral alignment.
timeFrame: 19 weeks
Secondary outcomes:
measure: Physical and social activities and quality of life will be measured with the COOP
timeFrame: 19 weeks
measure: Functional health will be measured with the SF-36
timeFrame: 19 weeks
measure: Depression will be measured using the Geriatric Depression Scale (GDS)
timeFrame: 19 weeks
measure: Treatment satisfaction will be measured using a 5-point Likert scale.
timeFrame: 19 weeks
measure: Reduction in pain medication usage
timeFrame: 19 weeks
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: William D Grant, EdD
role: PRINCIPAL_INVESTIGATOR
References: