Mechanical Low Back Pain Clinical Trial
Official title:
Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial
Verified date | August 2012 |
Source | Walsh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.
Status | Completed |
Enrollment | 149 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study. - For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments. Exclusion Criteria: - The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) - Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45° - Muscle weakness involving a major muscle group of the lower extremity, - Diminished lower extremity muscle stretch reflex - Diminished or absent sensation to pinprick in any lower extremity dermatome) - Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Walsh University | North Canton | Ohio |
Lead Sponsor | Collaborator |
---|---|
Walsh University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry disability index | Change score | Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. | No |
Secondary | Numeric Pain Rating Scale (NPRS) | Change score | Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. | No |
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