Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Shoulder Pain
- Sponsor
- University of Colorado, Denver
- Enrollment
- 140
- Locations
- 9
- Primary Endpoint
- Change in Shoulder Pain and Disability Index (SPADI) Score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Shoulder Pain and Disability Index (SPADI) Score
Time Frame: 1 week, 4 weeks, 6 months
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.
Secondary Outcomes
- Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)(1 week, 4 weeks and 6 months)
- Global Rating of Change (GROC)(1 week, 4 weeks, 6 months)
- Change in the Numeric Pain Rating Scale (NPRS)(1 week, 4 weeks, 6 months)
- Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)(1 week, 4 weeks, 6 months)