NCT00764764

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
Last Updated

October 4, 2016

Status Verified

July 1, 2009

Enrollment Period

Same day

First QC Date

October 1, 2008

Last Update Submit

October 3, 2016

Conditions

Shoulder ImpingementShoulder PainRotator Cuff TendinitisCervical Degenerative Joint Disease

Keywords

shoulder painrotator cuffimpingementcervical referred painneural tension

Outcome Measures

Primary Outcomes (1)

  • Active Shoulder Scaption range of motion

    3 weeks, 6 weeks

Secondary Outcomes (1)

  • DASH Functional Questionaire

    3 weeks, 6 weeks

Study Arms (2)

I

ACTIVE COMPARATOR

Group I - Shoulder treatment only

Procedure: shoulder treatment

II

EXPERIMENTAL

Cervical and shoulder treatment

Procedure: Shoulder AND cervical treatment

Interventions

shoulder treatmentPROCEDURE

shoulder exercise, joint mobilization, home program, posture

I
Shoulder AND cervical treatmentPROCEDURE

Cervical and shoulder joint mobilization, exercise, posture, and home program

II

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charleston Area Medical Center Physical Therapy and Sports Medicine

Charleston, West Virginia, 25311, United States

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder PainRotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRuptureTendon Injuries

Study Officials

  • Clark K Vaughan, MHSc, PT

    CAMC Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2008

Last Updated

October 4, 2016

Record last verified: 2009-07

Locations

US(1)