Clinical trial NCT01744002: Neck Mobs and Impingement
Official title: The Addition of Cervical Unilateral Posterior Anterior Mobilization (UPA) in the Treatment of Patients With Shoulder Impingement Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder and Neck
Keywords: Shoulder, Impingement syndrome, Neck
Lead sponsor: Walsh University
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: All treatment will be provided by licensed physical therapist within the United States. The clinicians affiliated with this study have experience in data collection and have participated in a recent trial that was sponsored by Walsh University.

At baseline, after consent for the study, patients will be randomized into two groups: 1) shoulder treatment and active mobilization to the neck and 2) shoulder treatment and placebo mobilization to the neck. Baseline data will be collected including all self-report measures.

Both groups will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises. The active neck group will receive UPA's to the cervical spine; applied as 3 X 30 seconds, to each comparable (stiff or painful) segment. The physical therapist will place their hands on the neck of the patient for the placebo group but will not perform the oscillations that are characteristic of mobilization.

All patients will receive a home program designed to increase range of motion and strength. None of the home program focused exercises will be targeted to the neck. The shoulder exercises will be tailored to each specific patient and will not be standardized.

Patients will be treated for the duration of their care using the same foci (1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises). The length of the treatment will be determined by the progress of the patient and by the attending therapist.

Eligibility criteria: 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).

Primary outcomes:
measure: Quick Disabilities of Shoulder and Hand Questionaire (QuickDASH)
timeFrame: participants will be followed for the duration of the treatment which is on average 4 weeks
Secondary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: participants will be followed for the duration of the treatment which is on average 4 weeks
Other outcomes:
measure: Patient Acceptable Symptom State (PASS)
timeFrame: participants will be followed for the duration of the treatment which is on average 4 weeks
Locations:
city: North Canton
country: United States
facility: Walsh University
state: Ohio
Study officials:
affiliation: Walsh U
name: Chad Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: