Shoulder and Neck Clinical Trial
Official title:
The Addition of Cervical Unilateral Posterior Anterior Mobilization (UPA) in the Treatment of Patients With Shoulder Impingement Syndrome: A Randomized Clinical Trial
| Verified date | December 2012 |
| Source | Walsh University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The objective of this study is to investigate whether treatment directed at the neck and
shoulder is more beneficial than treatment directed solely at the shoulder; for patients
with shoulder impingement syndrome.
(The hypothesis is that patients who receive neck mobilization will improve at a more
significant rate than those who do not receive neck mobilization)
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | March 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients, age 18 and older, with shoulder impingement syndrome, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study by the treating physical therapists. For patients to meet inclusion requirements, they require the following: 1. Report pain or dysfunction with elevated (overhead) arm activities, Demonstrate pain during active shoulder movements 2. Demonstrate a positive Neer or Hawkins Kennedy Test 3. Report an onset that is non-traumatic 4. Report an onset within the last 12 months 5. Demonstrate a painful arc of movement during forward elevation of the arm from 60° to 120° Exclusion Criteria: - Exclusion criteria will include The presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), a history of frozen shoulder, disorders of the acromioclavicular joint, degenerative arthritis of the glenohumeral joint, calcifying tendonitis, shoulder instability, posttraumatic disorders, or shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine disorders (e.g., cervical radiculopathy). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Walsh University | North Canton | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Walsh University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Patient Acceptable Symptom State (PASS) | The PASS is the symptom state in which the patients feel that their current well-being is acceptable. The question is dichotomous (yes or no) | participants will be followed for the duration of the treatment which is on average 4 weeks | No |
| Primary | Quick Disabilities of Shoulder and Hand Questionaire (QuickDASH) | The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The tool has been validated and has similar psychometric properties to the DASH | participants will be followed for the duration of the treatment which is on average 4 weeks | No |
| Secondary | Numerical Pain Rating Scale (NPRS) | The NPRS will be used to capture the patient's level of pain. Patients will be asked to indicate the intensity of current, best, and worst levels of pain over the past 24 hours, using an 11-point scale ranging from 0 "no pain" to 10 "worst pain imaginable." The average of the 3 ratings will be used to represent the patient's level of pain over the previous 24 hours. | participants will be followed for the duration of the treatment which is on average 4 weeks | No |