Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00916734|
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : December 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: MDT (McKenzie Method) Procedure: Spinal thrust manipulation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||December 2009|
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
- Pain level as measured on numerical pain rating scale [ Time Frame: 1 year ]
- Oswestry score [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916734
|United States, New York|
|Amherst, New York, United States, 14226|
|Principal Investigator:||Ronald J Schenk, PT, PhD||Daemen College|