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

NCT ID: NCT00916734

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

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.

Conditions

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Low Back Pain

Keywords

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McKenzie thrust manipulation clinical prediction rule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Spinal Manipulation Group

Subjects who received spinal thrust manipulation as an intervention.

Group Type EXPERIMENTAL

Spinal thrust manipulation

Intervention Type PROCEDURE

Subjects who receive spinal thrust manipulation as an intervention.

McKenzie MDT Group

Group Type ACTIVE_COMPARATOR

MDT (McKenzie Method)

Intervention Type PROCEDURE

Subjects who perform exercises in their direction of preference.

Interventions

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MDT (McKenzie Method)

Subjects who perform exercises in their direction of preference.

Intervention Type PROCEDURE

Spinal thrust manipulation

Subjects who receive spinal thrust manipulation as an intervention.

Intervention Type PROCEDURE

Other Intervention Names

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functional outcomes

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daemen College

OTHER

Sponsor Role lead

Responsible Party

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Ronald J. Schenk

Associate Professor Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald J Schenk, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Daemen College

Locations

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Daemen College

Amherst, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SOCH/IRB/0614

Identifier Type: -

Identifier Source: org_study_id