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Neck Mobs and Impingement

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ClinicalTrials.gov Identifier: NCT01744002
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
Chad Cook, Walsh University

Study Description
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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)


Condition or disease Intervention/treatment Phase
Shoulder and Neck Other: Shoulder treatment and neck mobilization Other: Control Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Shoulder Treatment with Neck Mobilization
The experiment group 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; and Unlateral Posterior Anterior Mobilization to the cervical spine; applied as 3 X 30 seconds, to each comparable (stiff or painful) segment.
 Other: Shoulder treatment and neck mobilization
This group 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; and joint mobilizations to the neck.
Active Comparator: Control Group
The control group 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.
 Other: Control
This group 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.


Outcome Measures
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Primary Outcome Measures :
  1. Quick Disabilities of Shoulder and Hand Questionaire (QuickDASH) [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ]
    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


Secondary Outcome Measures :
  1. Numerical Pain Rating Scale (NPRS) [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ]
    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.


Other Outcome Measures:
  1. Patient Acceptable Symptom State (PASS) [ Time Frame: participants will be followed for the duration of the treatment which is on average 4 weeks ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744002


Locations
United States, Ohio
Walsh University
North Canton, Ohio, United States, 44720
Sponsors and Collaborators
Walsh University
Investigators
Principal Investigator: Chad Cook, PhD Walsh U
More Information
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Responsible Party: Chad Cook, Principal Investigator, Walsh University
ClinicalTrials.gov Identifier: NCT01744002     History of Changes
Other Study ID Numbers: 12812
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2012

Keywords provided by Chad Cook, Walsh University:
Shoulder, Impingement syndrome, Neck

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries