Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 3/16/2015 |
| Start Date: | January 2011 |
| End Date: | December 2012 |
| Contact: | dean martz, m.d. |
| Email: | dmartz@neuroandspine.com |
| Phone: | 509-624-9112 |
Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.
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.
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.
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.
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.
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
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