Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-25 @ 3:36 PM
Study NCT ID:
NCT01236092
Status:
TERMINATED
Last Update Posted:
2015-04-08
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
Sponsor:
Michael Wilson & Associates Health Care Consulting, LLC
Organization:
Study Overview
Official Title:
Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: