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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald J. Schenk, Daemen College
ClinicalTrials.gov Identifier:
NCT00916734
First received: June 8, 2009
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Procedure: MDT (McKenzie Method)
Procedure: Spinal thrust manipulation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daemen College:

Primary Outcome Measures:
  • Pain level as measured on numerical pain rating scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916734

Locations
United States, New York
Daemen College
Amherst, New York, United States, 14226
Sponsors and Collaborators
Daemen College
Investigators
Principal Investigator: Ronald J Schenk, PT, PhD Daemen College
  More Information

No publications provided

Responsible Party: Ronald J. Schenk, Associate Professor Physical Therapy, Daemen College
ClinicalTrials.gov Identifier: NCT00916734     History of Changes
Other Study ID Numbers: SOCH/IRB/0614
Study First Received: June 8, 2009
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Daemen College:
McKenzie
thrust manipulation
clinical prediction rule

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013