Study of the Effect of Neck Treatment on Shoulder Impingement

Shoulder Pain Clinical Trial

Official title:

Shoulder Impingement: A By-Product of Cervical Spine Dysfunction?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764764
• Other study ID #: 08-01-2014
• Status: Terminated
• Phase: Phase 1
• First received: October 1, 2008
• Last updated: October 3, 2016
• Start date: May 2008

Study information

• Verified date: July 2009
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis
• Rotator Cuff Tendinitis
• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain
• Tendinopathy

Intervention

Procedure:
• shoulder treatment
shoulder exercise, joint mobilization, home program, posture
• Shoulder AND cervical treatment
Cervical and shoulder joint mobilization, exercise, posture, and home program

Locations

Country	Name	City	State
United States	Charleston Area Medical Center Physical Therapy and Sports Medicine	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active Shoulder Scaption range of motion		3 weeks, 6 weeks	No
Secondary	DASH Functional Questionaire		3 weeks, 6 weeks	No