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

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, we will determine
if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise
alone.

Inclusion Criteria:

1. 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)

2. Age between 18-65 years old

3. Shoulder Pain and Disability (SPADI) score > 20 points

Exclusion Criteria:

1. 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.)

2. Acute fractures in the shoulder region.

3. Acute severe trauma in the cervical or thoracic region in the last 6 weeks.

4. Contraindications to manipulative therapy (for example osteoporosis of the
cervicothoracic spine).

5. 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.

6. Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms

7. 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

8. Prior surgery to the neck or thoracic spine involving fusion or open reduction
internal fixation.

9. Insufficient English language skills to complete all questionnaires

10. Inability to comply with treatment and follow-up schedule