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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00916734
Enrollment
31
Registered
2009-06-09
Start date
2007-11-30
Completion date
2009-12-31
Last updated
2011-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

McKenzie, thrust manipulation, clinical prediction rule

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.

Interventions

PROCEDUREMDT (McKenzie Method)

Subjects who perform exercises in their direction of preference.

PROCEDURESpinal thrust manipulation

Subjects who receive spinal thrust manipulation as an intervention.

Sponsors

Daemen College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain level as measured on numerical pain rating scale1 year

Secondary

MeasureTime frame
Oswestry score1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026