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

Completed · Phase 2/Phase 3

Conditions studied: Shoulder Pain

In brief

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.

Key facts

Study ID

NCT01571674

Run by

University of Colorado, Denver

People needed

140

Starts

2012-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-05-17

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 to the right)
• Age between 18-65 years old
• Shoulder Pain and Disability (SPADI) score > 20 points

You may not qualify if…

• 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

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States
• Waldron's Peak Physical Therapy — Boulder, Colorado, United States
• Wardenburg Health Center at the University of Colorado — Boulder, Colorado, United States
• Franklin Pierce University — Concord, New Hampshire, United States
• Northern Navajo Medical Center — Shiprock, New Mexico, United States
• Temple University — Philadelphia, Pennsylvania, United States
• VCUHS- Virginia Commonwealth University Health System — Richmond, Virginia, United States
• University of Puget Sound — Tacoma, Washington, United States
• Gundersen Lutheran — Onalaska, Wisconsin, United States

Full record on ClinicalTrials.gov

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