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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Shoulder Pain

Treatments: Procedure: Manipulation + Exercise Group; Procedure: Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01571674

12-0040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Manipulation + Exercise Group

Experimental group

Description:

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.

Treatment:

Procedure: Manipulation + Exercise Group

Procedure: Exercise Group

Exercise Group

Active Comparator group

Description:

The exercise group will be treated with a stretching and strengthening program.

Treatment:

Procedure: Exercise Group