Neck Mobs and Impingement

Phase 2

Completed

• Conditions: Shoulder and Neck
• Interventions: Other: Shoulder treatment and neck mobilization; Other: Control

• Registration Number: NCT01744002
• Lead Sponsor: Walsh University

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.

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-12
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder Treatment with Neck Mobilization	Shoulder treatment and 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.
Control Group	Control	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.

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of Shoulder and Hand Questionaire (QuickDASH)	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

Name	Time	Method
Numerical Pain Rating Scale (NPRS)	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.

Trial Locations

Locations (1)

Walsh University; 🇺🇸 North Canton, Ohio, United States