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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

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:

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:
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
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

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

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

NCT ID

NCT00764764

First Posted

October 1, 2008

Last Updated

October 3, 2016

Sponsor

CAMC Health System

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

Arm Type

Active Comparator

Arm Description

Group I - Shoulder treatment only

Arm Title

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

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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