Low Back Pain, Radiculopathy
Conditions
Keywords
resolution of low back pain, show measurable improvement in disc measurement, conservative therapy vs. surgery in resolving low back pain
Brief summary
The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.
Detailed description
Patients will be placed randomly in the control group and will receive 10 weeks of standard physical therapy or in the study group and receive an equivalent 10 weeks therapy utilizing vibration, unweighting, therapeutic exercise and manual mobilization. The study uses a baseline MRI and x-rays which have shown the justification for surgical intervention and during the course of the protocol will have repeat MRI's and x-rays to determine any statistical change in the lumbar spine resulting in reduction or elimination of pain, improved range of motion, improvements in performance and reduction or elimination for the need for surgical intervention. Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions,disc height, canal stenosis, lumbosacral angle and facet spacing. Questionnaires will be completed during the course of the treatment and post-treatment at 6 months and one year. The final follow up phone call to the patient will be made following 24 months post initial treatment to determine the current patient status pertaining to low back pain, subsequent treatment, surgery, etc. Final study documentation will occur at that time. Intermediate results at one year will compare the control group vs. the study group for overall result differences.
Interventions
OTHERconservative therapy - traction, vibration, exercise
10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.
Sponsors
Pneumex Corporation
Michael Wilson & Associates Health Care Consulting, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* MRI of the lumbar spine showing symptoms and severity to qualify for surgery * 25 to 65 years of age * Diagnosis of low back pain for 3-12 months * Potential surgical candidates but not mandatory
Exclusion criteria
* any medical or physical conditions deemed unacceptable by the participants physician or health care provider * Evidence of progressive or debilitative medical conditions i.e. metastatic cancer, major stroke, crippling arthritis, unstable angina, orthostatic hypotension, hemiplegia, multiple sclerosis or Parkinson's disease. * Any condition that would preclude the additional burden of a repeat MRI or preclude active involvement in the protocol or physical therapy * Active use of tobacco products * Prior back surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic changes in the low back | 6 months following enrollment | Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions, disc height, canal stenosis, lumbrosacral angle, and facet spacing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| determine the percentage of patients who do not obtain relief of symptoms from either therapy and move on to surgery and determine the statistical difference between therapies. | one year following initiation of therapy | The comparison of convervative therapies, the control group with standard physical therapy and the study group, serve as the comparitive for the success as measured by the number from each group which move to surgery within the one year. |
Countries
United States
Outcome results
None listed