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Completed

NCT Number: NCT01744002

Neck Mobs and Impingement

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)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Walsh University

North Canton, Ohio, 44720, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Report pain or dysfunction with elevated (overhead) arm activities, Demonstrate pain during active shoulder movements
  • Demonstrate a positive Neer or Hawkins Kennedy Test
  • Report an onset that is non-traumatic
  • Report an onset within the last 12 months
  • 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).

Treatment and study plan

Shoulder treatment and neck mobilization

Other

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.

Control

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Walsh University

Other

Registry information

Official study title

The Addition of Cervical Unilateral Posterior Anterior Mobilization (UPA) in the Treatment of Patients With Shoulder Impingement Syndrome: A Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.