Clinical trial NCT01236092: Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
Official title: Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radiculopathy
Low Back Pain
Keywords: resolution of low back pain
show measurable improvement in disc measurement
conservative therapy vs. surgery in resolving low back pain
Lead sponsor: Michael Wilson & Associates Health Care Consulting, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pneumex Corporation
First posted: 2010-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic changes in the low back
timeFrame: 6 months following enrollment
Secondary outcomes:
measure: 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.
timeFrame: one year following initiation of therapy
Other outcomes:
Locations:
city: Spokane,
country: United States
facility: St. Luke's Rhabilitation Institute and Revita Back
state: Washington
Study officials:
affiliation: Inland Neurosurgery and Spine
name: Dean Martz, m.d.
role: PRINCIPAL_INVESTIGATOR
References: