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Study of the Effect of Neck Treatment on Shoulder Impingement

Primary Purpose

Shoulder Impingement, Shoulder Pain, Rotator Cuff Tendinitis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
shoulder treatment
Shoulder AND cervical treatment
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement focused on measuring shoulder pain, rotator cuff, impingement, cervical referred pain, neural tension

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charleston Area Medical Center Physical Therapy and Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

I

II

Arm Description

Group I - Shoulder treatment only

Cervical and shoulder treatment

Outcomes

Primary Outcome Measures

Active Shoulder Scaption range of motion

Secondary Outcome Measures

DASH Functional Questionaire

Full Information

First Posted
October 1, 2008
Last Updated
October 3, 2016
Sponsor
CAMC Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00764764
Brief Title
Study of the Effect of Neck Treatment on Shoulder Impingement
Official Title
Shoulder Impingement: A By-Product of Cervical Spine Dysfunction?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CAMC Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement, Shoulder Pain, Rotator Cuff Tendinitis, Cervical Degenerative Joint Disease
Keywords
shoulder pain, rotator cuff, impingement, cervical referred pain, neural tension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Group I - Shoulder treatment only
Arm Title
II
Arm Type
Experimental
Arm Description
Cervical and shoulder treatment
Intervention Type
Procedure
Intervention Name(s)
shoulder treatment
Intervention Description
shoulder exercise, joint mobilization, home program, posture
Intervention Type
Procedure
Intervention Name(s)
Shoulder AND cervical treatment
Intervention Description
Cervical and shoulder joint mobilization, exercise, posture, and home program
Primary Outcome Measure Information:
Title
Active Shoulder Scaption range of motion
Time Frame
3 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
DASH Functional Questionaire
Time Frame
3 weeks, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. production or increase in pain in any of the area(s) above with one of the following: active shoulder flexion or scaption (elevation in the scapular plane) impingement sign as described by Neer (1983) Hawkins-Kennedy impingement test (1980) resisted supraspinatus, shoulder internal or external strength testing patient is between 40 and 70 years of age Exclusion Criteria: Any previous history of surgery or fracture in the cervical spine, upper thoracic spine, humerus, scapula, or clavicle Any previous or current history of psychiatric or psychological treatment 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 Any prolonged exposure to blood thinners or steroids Constant lateral humeral pain that does not alter with movement, time of day, or position for the last 60 days 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 A score of 11 or higher in the sensory plus affective dimensions of pain with the short-form of the McGill Pain Questionnaire Any injections in the shoulder, cervical spine or upper thoracic spines in the last 6 months Pain in the posterior shoulder, mid- and lower cervical spine, or upper thoracic spine that the patient wants treated Onset of symptoms associated with trauma or trauma to the neck/shoulder area in the last 60 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark K Vaughan, MHSc, PT
Organizational Affiliation
CAMC Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charleston Area Medical Center Physical Therapy and Sports Medicine
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25311
Country
United States

12. IPD Sharing Statement

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Study of the Effect of Neck Treatment on Shoulder Impingement

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