NCT01236092

Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol

Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Michael Wilson & Associates Health Care Consulting, LLC · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiculopathy
• Low Back Pain

Interventions

Type	Name	Description
OTHER	conservative therapy - traction, vibration, exercise	10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2010-11-08
• Last updated: 2015-04-08

Locations

1 site across 1 country: United States