Neck Pain Clinical Trial
Official title:
Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Background: Recently a clinical prediction rule (CPR) has been developed that identifies
patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine
thrust manipulation and an active range of motion exercise. Although the initial predictor
variables identified during the development of a thoracic spine manipulation CPR seem to
have adequate face validity, there is no guarantee that these factors will persist in a
different group of patients, even ones with similar characteristics as those used in the
initial exploratory study.
Purpose: The purpose of this follow-up study in which patients will be randomly assigned to
receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic
exercise alone will be to investigate the validity of the previously developed CPR. If the
CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine
thrust manipulation should experience improved outcomes compared to patients who are
negative on the CPR and receive thoracic spine manipulation, and compared to patients who
are positive on the CPR but receive the intervention believed to be effective for another
subgroup of patients with neck pain.
Design: We will conduct a multi-center randomized clinical trial to assess the effectiveness
of a previously-developed CPR for identifying patients with neck pain likely to respond to a
thoracic spine thrust manipulation. Subjects between the ages of 18 and 60 with a primary
report of neck pain will be randomized to receive manipulation plus an exercise program or
to receive an exercise program only.
Methods: One hundred and forty patients with a primary complaint of neck pain who meet the
inclusion/exclusion criteria and consent to participate will be enrolled in the study. We
based sample size calculations on detecting a statistically significant difference between
any of the 4 cells of the study which include the patients status on the rule (patients that
meet the CPR and patients that do not meet the CPR) and treatment group (manipulation and
exercise) by using the 1-week Neck Disability Index (NDI) score at an alpha-level of 0.05.
To detect a 10 point change in NDI, with an expected standard deviation of 12 points at the
1 week follow up (effect size 0.80) with 90% power using a two-tailed hypothesis and
assuming a 50% distribution of patients who do and do not meet the rule, 31 patients per
cell are required. We will recruit 140 subjects into the study to control for drop-outs
prior to the 1 and 4 week follow-up and possible distribution discrepancies between the
classifications. The primary outcome point is four-weeks after randomization, with change in
disability as measured by the NDI, serving as the primary outcome measure.
Data Analysis: We will examine the primary aim with a 3-way repeated-measures analysis of
variance (ANOVA) with treatment group (manipulation vs. exercise) and status on the rule
(positive or negative) as the between subjects independent variables and time (baseline, 1
week and 4 weeks) as the within-subjects independent variable. The dependent variable will
be disability (NDI score). The hypothesis of interest is the 3-way group * CPR status * time
interaction. We will perform planned pairwise comparisons at each follow-up period by using
the Bonferroni inequality.
Significance: The results of this study should improve clinical decision-making and outcomes
from physical therapy intervention by assisting clinicians in their ability to select
appropriate manual physical therapy techniques for patients with neck pain. Validation of
the CPR would enhance the certainty in which therapists will be able to identify patients
with neck pain who are likely to exhibit a dramatic response to thoracic spine thrust
manipulation as measured by reduced levels of disability) and therapeutic exercises. Results
of the study will impact future patients with neck pain as it will provide a method of
classification in which based on their clinical presentation therapists can determine the
likelihood that they will or will not respond to thoracic spine thrust manipulation.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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