Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation

Completed · Phase 2

Conditions studied: Shoulder Pain

In brief

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.

Key facts

Study ID: NCT00835302
Run by: University of Colorado, Denver
People needed: 80
Starts: 2006-10-01
Expected to finish: 2009-03-01
Last updated by the study team: 2013-01-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 at right)
Age between 18-65 years old
Shoulder Pain and Disability Index (SPADI) score greater than 20 points (full description of this measure provided in self report measures section)

You may not qualify if…

Medical red flags noted in the patient's Medical Screening Questionnaire(i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, weight loss, fever, prolonged history of steroid use, etc.)
Acute fractures in the shoulder region.
Acute severe trauma to the cervical (neck) or thoracic (upper back) regions 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 as they have only been validated in English.
Inability to comply with treatment and follow-up schedule

Where it is running

University of Colorado Denver — Aurora, Colorado, United States
Wardenburg Health Center — Boulder, Colorado, United States
Physiotherapy Associates — Greenwood Village, Colorado, United States
Newton Wellesley Hospital — Newton, Massachusetts, United States
Groves Physical Therapy — Saint Paul, Minnesota, United States
Concord Hospital — Concord, New Hampshire, United States

Full record on ClinicalTrials.gov

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