Neck Mobs and Impingement

NCT ID: NCT01744002

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Shoulder and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shoulder treatment and neck mobilization

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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°

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walsh University

OTHER

Sponsor Role: lead

Responsible Party

Chad Cook

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chad Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

Walsh U

Locations

Walsh University

North Canton, Ohio, United States

Countries

United States

Other Identifiers

12812

Identifier Type: -

Identifier Source: org_study_id