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Study of the Effect of Neck Treatment on Shoulder Impingement

This study has been terminated.
(PI left institution)
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00764764
First received: October 1, 2008
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Shoulder Impingement
Shoulder Pain
Rotator Cuff Tendinitis
Cervical Degenerative Joint Disease
 Procedure: shoulder treatment
Procedure: Shoulder AND cervical treatment
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shoulder Impingement: A By-Product of Cervical Spine Dysfunction?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Active Shoulder Scaption range of motion [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DASH Functional Questionaire [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Group I - Shoulder treatment only
 Procedure: shoulder treatment
shoulder exercise, joint mobilization, home program, posture
Experimental: II
Cervical and shoulder treatment
 Procedure: Shoulder AND cervical treatment
Cervical and shoulder joint mobilization, exercise, posture, and home program

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764764

Locations
United States, West Virginia
Charleston Area Medical Center Physical Therapy and Sports Medicine
Charleston, West Virginia, United States, 25311
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Clark K Vaughan, MHSc, PT CAMC Health System
  More Information

No publications provided

Responsible Party: Clark Vaughan, CAMC
ClinicalTrials.gov Identifier: NCT00764764     History of Changes
Other Study ID Numbers: 08-01-2014
Study First Received: October 1, 2008
Last Updated: July 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
shoulder pain
rotator cuff
impingement
cervical referred pain
neural tension

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Shoulder Pain
Tendinopathy
Shoulder Impingement Syndrome
Musculoskeletal Diseases
Arthritis
 Rheumatic Diseases
Arthralgia
Pain
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013