Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
|Low Back Pain||Procedure: MDT (McKenzie Method) Procedure: Spinal thrust manipulation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation|
- Pain level as measured on numerical pain rating scale [ Time Frame: 1 year ]
- Oswestry score [ Time Frame: 1 year ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Spinal Manipulation Group
Subjects who received spinal thrust manipulation as an intervention.
Procedure: Spinal thrust manipulation
Subjects who receive spinal thrust manipulation as an intervention.
|Active Comparator: McKenzie MDT Group||
Procedure: MDT (McKenzie Method)
Subjects who perform exercises in their direction of preference.
Other Name: functional outcomes
With the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. Physical therapy interventions for management of LBP include therapeutic exercises and spinal manipulation.
The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.
The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.
Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916734
|United States, New York|
|Amherst, New York, United States, 14226|
|Principal Investigator:||Ronald J Schenk, PT, PhD||Daemen College|