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

December 2, 2011 updated by: Ronald J. Schenk, Daemen College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Amherst, New York, United States, 14226
        • Daemen College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • functional outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain level as measured on numerical pain rating scale
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Oswestry score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daemen College

Investigators

  • Principal Investigator: Ronald J Schenk, PT, PhD, Daemen College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOCH/IRB/0614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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