Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): manual therapy; exercise
Intervention type(s): Other; Other
Intervention description(s): manual therapy - thoracic spine thrust manipulation; therapeutic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment