Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation.

Detailed Description
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The investigators have recently identified prognostic variables in a preliminary Clinical Prediction Rule (CPR) that are purported to identify patients with shoulder pain who respond favorably to cervicothoracic spinal manipulative therapy (SMT) and daily home exercises of cervical and thoracic active range of motion exercises. These prognostic variables have been identified in a single study, and therefore it is not known if these factors will be valid in a different group of patients, even ones with similar characteristics as those used in the investigators' initial exploratory study. Further study of these identified factors is needed for validation in an independent sample of patients, which will improve generalizability for clinical practice. In this study, patients with a primary complaint of shoulder pain will be randomly assigned to receive cervicothoracic spine manipulation followed by therapeutic exercises or therapeutic exercise alone. If the variables are in fact meaningful, patients who exhibit 3 or more of the identified prognostic variables and receive cervicothoracic SMT should experience improved outcomes compared to patients who have less than 3 of these variables and receive the same intervention. Additionally, patients who exhibit 3 or more of the identified variables that receive cervicothoracic SMT should also have superior outcomes to patients who exhibit 3 or more of the identified variables and receive an alternate intervention (exercise only). Finally, the investigators will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.

Official Title
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Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Manipulation + Exercise Group
* Procedure: Exercise Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram to the right) Age between 18-65 years old Shoulder Pain and Disability (SPADI) score > 20 points Exclusion Criteria: Medical red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) Acute fractures in the shoulder region. Acute severe trauma in the cervical or thoracic region in the last 6 weeks. Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine). Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc. Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: Muscle weakness involving a major muscle group of the upper extremity Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes) Diminished or absent sensation to pinprick in any upper extremity dermatome Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation. Insufficient English language skills to complete all questionnaires Inability to comply with treatment and follow-up schedule

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulation + Exercise Group<br>The treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group. | Procedure: Manipulation + Exercise Group<br>* First 2 sessions High-velocity, low-amplitude manipulations to the thoracic spine. Low-velocity mid to end-range mobilizations to the cervical spine. Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program<br>Procedure: Exercise Group<br>* First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program<br>|
| Active Comparator: Exercise Group<br>The exercise group will be treated with a stretching and strengthening program. | Procedure: Exercise Group<br>* First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Shoulder Pain and Disability Index (SPADI) Score | The SPADI is a 13 item questionnaire. The pain domain consists of five questions and the disability domain consists of eight. Each question refers to the past week. | 1 week, 4 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH) | The QuickDASH4 is an eleven-item questionnaire that addresses symptoms and physical function in people with any or multiple disorders involving the upper limb. | 1 week, 4 weeks and 6 months | 
| Global Rating of Change (GROC) | The GROC asks patients to rate whether their health condition has improved or deteriorated over time to determine the efficacy of a particular treatment. Scores range from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. | 1 week, 4 weeks, 6 months | 
| Change in the Numeric Pain Rating Scale (NPRS) | An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase No Pain and on the right with the phrase Worst Imaginable Pain. Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain. | 1 week, 4 weeks, 6 months | 
| Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ) | The FABQ is a 16-item questionnaire designed to quantify fear and avoidance beliefs in patients with musculoskeletal disorders. The FABQ has two sub-scales, a 7-item scale to measure fear-avoidance beliefs about work and a 4-item scale to measure fear-avoidance beliefs about physical activity. Each item is scored from 0-6 with possible scores ranging between 0-24 and 0-42 for the physical activity and work subscales, respectively, with higher scores representing increased fear-avoidance beliefs. | 1 week, 4 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical, Clinical Prediction Rule, Exercise, Manipulation, Manual therapy, Mobilization, Physical Therapy, Prognosis, Shoulder pain, Thoracic