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Study of the Effect of Neck Treatment on Shoulder Impingement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764764
Recruitment Status : Terminated (PI left institution)
First Posted : October 2, 2008
Last Update Posted : October 4, 2016
Information provided by:
CAMC Health System

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Active Shoulder Scaption range of motion [ Time Frame: 3 weeks, 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
DASH Functional Questionaire [ Time Frame: 3 weeks, 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of the Effect of Neck Treatment on Shoulder Impingement
Official Title  ICMJE Shoulder Impingement: A By-Product of Cervical Spine Dysfunction?
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Shoulder Impingement
  • Shoulder Pain
  • Rotator Cuff Tendinitis
  • Cervical Degenerative Joint Disease
Intervention  ICMJE
  • Procedure: shoulder treatment
    shoulder exercise, joint mobilization, home program, posture
  • Procedure: Shoulder AND cervical treatment
    Cervical and shoulder joint mobilization, exercise, posture, and home program
Study Arms  ICMJE
  • Active Comparator: I
    Group I - Shoulder treatment only
    Intervention: Procedure: shoulder treatment
  • Experimental: II
    Cervical and shoulder treatment
    Intervention: Procedure: Shoulder AND cervical treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00764764
Other Study ID Numbers  ICMJE 08-01-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clark Vaughan, CAMC
Study Sponsor  ICMJE CAMC Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clark K Vaughan, MHSc, PT CAMC Health System
PRS Account CAMC Health System
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP