NCT01744002

Brief Summary

The objective of this study is to investigate whether treatment directed at the neck and shoulder is more beneficial than treatment directed solely at the shoulder; for patients with shoulder impingement syndrome. (The hypothesis is that patients who receive neck mobilization will improve at a more significant rate than those who do not receive neck mobilization)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 10, 2013

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

December 2, 2012

Last Update Submit

July 9, 2013

Conditions

Keywords

Shoulder, Impingement syndrome, Neck

Outcome Measures

Primary Outcomes (1)

  • Quick Disabilities of Shoulder and Hand Questionaire (QuickDASH)

    The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The tool has been validated and has similar psychometric properties to the DASH

    participants will be followed for the duration of the treatment which is on average 4 weeks

Secondary Outcomes (1)

  • Numerical Pain Rating Scale (NPRS)

    participants will be followed for the duration of the treatment which is on average 4 weeks

Other Outcomes (1)

  • Patient Acceptable Symptom State (PASS)

    participants will be followed for the duration of the treatment which is on average 4 weeks

Study Arms (2)

Shoulder Treatment with Neck Mobilization

EXPERIMENTAL

The experiment group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises; and Unlateral Posterior Anterior Mobilization to the cervical spine; applied as 3 X 30 seconds, to each comparable (stiff or painful) segment.

Other: Shoulder treatment and neck mobilization

Control Group

ACTIVE COMPARATOR

The control group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises.

Other: Control

Interventions

This group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises; and joint mobilizations to the neck.

Shoulder Treatment with Neck Mobilization
ControlOTHER

This group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Report pain or dysfunction with elevated (overhead) arm activities, Demonstrate pain during active shoulder movements
  • Demonstrate a positive Neer or Hawkins Kennedy Test
  • Report an onset that is non-traumatic
  • Report an onset within the last 12 months
  • Demonstrate a painful arc of movement during forward elevation of the arm from 60° to 120°

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walsh University

North Canton, Ohio, 44720, United States

Location

Study Officials

  • Chad Cook, PhD

    Walsh U

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 6, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

July 10, 2013

Record last verified: 2012-12

Locations