Status:
COMPLETED
Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation
Lead Sponsor:
University of Colorado, Denver
Conditions:
Shoulder Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ba...
Detailed Description
The point prevalence of shoulder symptoms has been reported to range from 20-33% and the incidence of shoulder complaints in the general population is increasing. Furthermore, several authors have rep...
Eligibility Criteria
Inclusion
- 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 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)
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00835302
Start Date
October 1 2006
End Date
March 1 2009
Last Update
January 30 2013
Active Locations (6)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
Wardenburg Health Center
Boulder, Colorado, United States, 80030
3
Physiotherapy Associates
Greenwood Village, Colorado, United States
4
Newton Wellesley Hospital
Newton, Massachusetts, United States