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

NCT01236092 | Terminated DMC

• 1 other identifier: mwilson consulting, llc
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Radiographic changes in the low back

  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.

  6 months following enrollment

Secondary Outcomes (1)

• 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

Interventions

conservative therapy - traction, vibration, exercise OTHER

10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI of the lumbar spine showing symptoms and severity to qualify for surgery
• to 65 years of age
• Diagnosis of low back pain for 3-12 months
• Potential surgical candidates but not mandatory

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Wilson & Associates Health Care Consulting, LLC: lead
• Pneumex Corporation: collaborator

Study Sites (1)

St. Luke's Rhabilitation Institute and Revita Back

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Radiculopathy; Low Back Pain

Interventions

Vibration; Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dean Martz, m.d.

  Inland Neurosurgery and Spine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 8, 2015

Record last verified: 2012-07

Locations

US (1)