Clinical trial NCT00764764: Study of the Effect of Neck Treatment on Shoulder Impingement
Official title: Shoulder Impingement: A By-Product of Cervical Spine Dysfunction?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Shoulder Impingement
Shoulder Pain
Rotator Cuff Tendinitis
Cervical Degenerative Joint Disease
Keywords: shoulder pain
rotator cuff
impingement
cervical referred pain
neural tension
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Active Shoulder Scaption range of motion
timeFrame: 3 weeks, 6 weeks
Secondary outcomes:
measure: DASH Functional Questionaire
timeFrame: 3 weeks, 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center Physical Therapy and Sports Medicine
state: West Virginia
Study officials:
affiliation: CAMC Health System
name: Clark K Vaughan, MHSc, PT
role: PRINCIPAL_INVESTIGATOR
References: