Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.

Detailed Description
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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.

Official Title
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Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: MDT (McKenzie Method)
* Procedure: Spinal thrust manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people who meet the clinical prediction rule for spinal manipulation Exclusion Criteria: people receiving worker's compensation those who have had spinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Manipulation Group<br>Subjects who received spinal thrust manipulation as an intervention. | Procedure: Spinal thrust manipulation<br>* Subjects who receive spinal thrust manipulation as an intervention.<br>|
| Active Comparator: McKenzie MDT Group<br> | Procedure: MDT (McKenzie Method)<br>* Subjects who perform exercises in their direction of preference.<br>* Other names: functional outcomes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level as measured on numerical pain rating scale |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry score |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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McKenzie, thrust manipulation, clinical prediction rule