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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MDT (McKenzie Method)
Spinal thrust manipulation
Sponsored by
Daemen College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring McKenzie, thrust manipulation, clinical prediction rule

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daemen College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal Manipulation Group

McKenzie MDT Group

Arm Description

Subjects who received spinal thrust manipulation as an intervention.

Outcomes

Primary Outcome Measures

Pain level as measured on numerical pain rating scale

Secondary Outcome Measures

Oswestry score

Full Information

First Posted
June 8, 2009
Last Updated
December 2, 2011
Sponsor
Daemen College
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1. Study Identification

Unique Protocol Identification Number
NCT00916734
Brief Title
Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
Official Title
Assessing Patient Response to Therapeutic Exercise Based on the Clinical Prediction Rule for Spinal Manipulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daemen College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
McKenzie, thrust manipulation, clinical prediction rule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulation Group
Arm Type
Experimental
Arm Description
Subjects who received spinal thrust manipulation as an intervention.
Arm Title
McKenzie MDT Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
MDT (McKenzie Method)
Other Intervention Name(s)
functional outcomes
Intervention Description
Subjects who perform exercises in their direction of preference.
Intervention Type
Procedure
Intervention Name(s)
Spinal thrust manipulation
Intervention Description
Subjects who receive spinal thrust manipulation as an intervention.
Primary Outcome Measure Information:
Title
Pain level as measured on numerical pain rating scale
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Oswestry score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Schenk, PT, PhD
Organizational Affiliation
Daemen College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daemen College
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States

12. IPD Sharing Statement

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

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