Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators seek to develop a clinical prediction rule (CPR) to identify patients with
      a primary complaint of shoulder pain who are likely to benefit from manual therapy to the
      neck and upper back regions. Manual therapy will include mobilizations (therapist moves the
      joints in an oscillating fashion) and manipulations (therapist performs a high velocity low
      amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from
      the subject history and physical examination will exist that maximize the accuracy of
      identifying patients with a primary complaint of shoulder pain likely to benefit from this
      manual therapy treatment based on a reference standard of patient-reported improvement.

      The investigators also seek to investigate the psychometric properties (how good a test is),
      including test retest reliability of a modified version of the Fear Avoidance Beliefs
      Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients
      with shoulder pain. The investigators will also look at the convergent validity (determine if
      measures that should be related are in reality related) and discriminant validity (show that
      measures that should not be related are in reality not related) of the modified FABQ and the
      TSK-11 in patients with shoulder pain.
    

Detailed description: 
      The point prevalence of shoulder symptoms has been reported to range from 20-33% and the
      incidence of shoulder complaints in the general population is increasing. Furthermore,
      several authors have reported low rates of perceived recovery (patient reports of "being
      cured") for patients with a new episode of shoulder or neck pain.3-6 According to Bot et al,
      less than 25% of patients with a first episode of shoulder pain reported recovery after 3
      months, and only 32% stated they had recovered (no longer had symptoms) after 1 year. Other
      studies have investigated the prognosis of shoulder pain in general practice. Croft et al
      reported recovery rates of only 21% after 6 months and 49% after 18 months. Van der Windt et
      al and Winters et al reported recovery rates of 51% and 59% after 12 to 18 months,
      respectively. Finally, Rekola et al reported that 25% of patients with shoulder or neck pain
      experienced at least one episode of recurrence within 12 months. These findings suggest that
      shoulder pain can be recurrent and frequently progresses to the chronic stage.

      The Guide to Physical Therapist Practice describes 5 components of patient management;
      examination, evaluation, diagnosis, prognosis, interventions and outcomes. Information
      collected during the examination is evaluated in an attempt to improve decision making
      regarding the most appropriate treatment strategy for the individual patient. Contrary to the
      medical model which attempts to identify pathology to arrive at a diagnosis, the diagnostic
      process in physical therapy involves classifying or labeling patients based on functional
      limitations (restrictions in activities caused by a certain condition) and impairments (loss
      or abnormality in function such as decreased strength or motion) in an attempt to
      specifically direct treatment. Clinical decision making regarding treatment involves a
      certain degree of uncertainty as to which interventions will maximize individual patient
      outcomes. While the amount of quality evidence supporting physical therapy interventions is
      increasing, this uncertainty can make it difficult to decide on an appropriate treatment
      strategy. The American Physical Therapy Association has stated that identifying subgroups of
      patients who are likely to benefit from specific treatments is a research priority. (APTA)
      The Guide to Physical Therapist Practice indicates that interventions such as
      mobilization/manipulation are utilized by physical therapists to manage patients who have
      shoulder pain. There is growing evidence that impairments in the cervicothoracic spine may
      contribute to shoulder pain, and that patients with shoulder pain may benefit from
      manipulation in this region. Manipulation is defined as a manual therapy technique comprising
      a continuum of skilled passive movements, including small-amplitude/high velocity movements
      (thrust) and oscillations (non-thrust), that is targeted at joints and soft tissues.

      While it is not likely that all patients who have with shoulder pain will benefit from
      manipulation (thrust and non-thrust) of the cervicothoracic spine, it is possible that a
      subgroup exists that will experience rapid and dramatic improvement with the use of these
      manual physical therapy techniques. It is our specific aim to develop a clinical prediction
      rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to
      benefit from cervicothoracic manipulation. The purpose of a CPR is to improve the clinician's
      accuracy in predicting a diagnosis or an expected outcome. For example, CPRs exist to improve
      the accuracy of diagnosing ankle fractures in individuals with acute injuries,predict the
      likelihood of death within four years for individuals with coronary disease, or determine
      when cervical radiographs are required for patients who have experienced neck trauma. The
      process of developing and testing a CPR has been described in detail elsewhere. Although CPRs
      can be developed to improve the accuracy of making a certain diagnosis, the focus of this
      project is to develop a CPR to predict a certain treatment outcome. The development of a CPR
      utilizes diagnostic properties of sensitivity, specificity, and positive and negative
      likelihood ratios, which are based on the individual patient. Thus their interpretation can
      be readily applied to an individual patient. Development of a CPR to accurately predict which
      patients with shoulder pain will likely experience a clinically meaningful improvement in
      pain and function with cervicothoracic spine manipulation before treatment would be immensely
      helpful for clinicians in the decision-making process. Thus the purpose of this project is to
      develop a CPR to identify patients with shoulder pain likely to benefit from cervicothoracic
      spine thrust and non-thrust manipulation.
    

Intervention name(s): Cervicothoracic manipulation
Intervention type(s): Procedure
Intervention description(s): Thrust and non-thrust manipulation to the cervical and thoracic spine
Other intervention name(s): Mobilization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical; Thoracic; Manipulation; Mobilization; Clinical prediction rule; Shoulder pain.