Study of the Effect of Neck Treatment on Shoulder Impingement

NCT ID: NCT00764764

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31

Brief Summary

The purpose of this pilot study is to conduct research to determine the most effective physical therapy treatment for a condition called shoulder impingement. This condition occurs when tissue in the shoulder is caught between the humerus (arm bone) and the scapula (shoulder blade). This causes pain when one tries to reach overhead or behind the back.

Two treatment methods will be used in the study. The first method uses the traditional treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The second method will use the traditional methods of shoulder treatment in addition to treatment of the cervical spine.

It is hypothesized that a group of patients between 40 and 70 years of age with signs and symptoms of shoulder impingement who receive physical therapy to the cervical spine and shoulder will report a higher level of functioning, will report less pain, and will gain more range of motion than a group of patients receiving physical therapy solely to the shoulder.

Conditions

Shoulder Impingement; Shoulder Pain; Rotator Cuff Tendinitis; Cervical Degenerative Joint Disease

Study Design

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

Study Groups

I

Group I - Shoulder treatment only

Group Type: ACTIVE_COMPARATOR

shoulder treatment

Intervention Type: PROCEDURE

shoulder exercise, joint mobilization, home program, posture

II

Cervical and shoulder treatment

Group Type: EXPERIMENTAL

Shoulder AND cervical treatment

Intervention Type: PROCEDURE

Cervical and shoulder joint mobilization, exercise, posture, and home program

Interventions

shoulder treatment

shoulder exercise, joint mobilization, home program, posture

Intervention Type: PROCEDURE

Shoulder AND cervical treatment

Cervical and shoulder joint mobilization, exercise, posture, and home program

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. the complaint of pain in either the anterior, lateral, or posterior aspect of the upper arm in an area extending from the acromion to the deltoid tubercle or to a point equally distal on the humerus.

2. production or increase in pain in any of the area(s) above with one of the following:

1. active shoulder flexion or scaption (elevation in the scapular plane)

2. impingement sign as described by Neer (1983)

3. Hawkins-Kennedy impingement test (1980)

4. resisted supraspinatus, shoulder internal or external strength testing

3. patient is between 40 and 70 years of age

Exclusion Criteria

1. Any previous history of surgery or fracture in the cervical spine, upper thoracic spine, humerus, scapula, or clavicle

2. Any previous or current history of psychiatric or psychological treatment

3. Any medical condition that predisposes patients to shoulder pain such as past or current history of diabetes mellitus, fibromyalgia, adhesive capsulitis, rheumatoid arthritis, shoulder osteoarthritis, osteoporosis, ankylosing spondylitis, vertebrobasilar artery insufficiency, pregnancy, or shoulder instability

4. Any prolonged exposure to blood thinners or steroids

5. Constant lateral humeral pain that does not alter with movement, time of day, or position for the last 60 days

6. Subjects with an active worker's compensation claim related to the cervical spine, shoulder, or upper thoracic spine, or subjects with any impending or current litigation related to the same areas

7. A score of 11 or higher in the sensory plus affective dimensions of pain with the short-form of the McGill Pain Questionnaire

8. Any injections in the shoulder, cervical spine or upper thoracic spines in the last 6 months

9. Pain in the posterior shoulder, mid- and lower cervical spine, or upper thoracic spine that the patient wants treated

10. Onset of symptoms associated with trauma or trauma to the neck/shoulder area in the last 60 days

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

CAMC

Principal Investigators

Clark K Vaughan, MHSc, PT

Role: PRINCIPAL_INVESTIGATOR

CAMC Health System

Locations

Charleston Area Medical Center Physical Therapy and Sports Medicine

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

08-01-2014

Identifier Type: -

Identifier Source: org_study_id