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

Primary Purpose

Radiculopathy, Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
conservative therapy - traction, vibration, exercise
Sponsored by
Michael Wilson & Associates Health Care Consulting, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring resolution of low back pain, show measurable improvement in disc measurement, conservative therapy vs. surgery in resolving low back pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Luke's Rhabilitation Institute and Revita Back

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The comparison of convervative therapies, the control group with standard physical therapy and the study group, serve as the comparitive for the success as measured by the number from each group which move to surgery within the one year.

Full Information

First Posted
November 4, 2010
Last Updated
April 7, 2015
Sponsor
Michael Wilson & Associates Health Care Consulting, LLC
Collaborators
Pneumex Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01236092
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Inadequate patient enrollment
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Michael Wilson & Associates Health Care Consulting, LLC
Collaborators
Pneumex Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
conservative therapy - traction, vibration, exercise
Intervention Description
10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.
Primary Outcome Measure Information:
Title
Radiographic changes in the low back
Description
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.
Time Frame
6 months following enrollment
Secondary Outcome Measure Information:
Title
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.
Description
The comparison of convervative therapies, the control group with standard physical therapy and the study group, serve as the comparitive for the success as measured by the number from each group which move to surgery within the one year.
Time Frame
one year following initiation of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Martz, m.d.
Organizational Affiliation
Inland Neurosurgery and Spine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Rhabilitation Institute and Revita Back
City
Spokane,
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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

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