Study of the Effect of Neck Treatment on Shoulder Impingement

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

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Pain; Rotator Cuff Tendinitis; Shoulder Impingement; Cervical Degenerative Joint Disease
• Intervention / Treatment: Procedure: shoulder treatment; Procedure: Shoulder AND cervical treatment

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25311
      • Charleston Area Medical Center Physical Therapy and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Active Shoulder Scaption range of motion	3 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
DASH Functional Questionaire	3 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Clark K Vaughan, MHSc, PT, CAMC Health System

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: shoulder pain; rotator cuff; impingement; cervical referred pain; neural tension
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Osteoarthritis; Rotator Cuff Injuries; Tendinopathy; Shoulder Impingement Syndrome; Joint Diseases; Shoulder Pain
• Other Study ID Numbers: 08-01-2014