NCT01753271

Brief Summary

Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement. Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

2.7 years

First QC Date

December 11, 2012

Last Update Submit

August 19, 2015

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index Change over time

    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

    2 weeks, 4 weeks, discharge

Secondary Outcomes (2)

  • Numeric Pain Rating Scale change over time

    2 weeks, 4 weeks, discharge

  • Fear Avoidance Beliefs Questionnaire change over time

    2 weeks, 4 weeks, discharge

Other Outcomes (2)

  • Shoulder range of motion change over time

    2 weeks, 4 weeks, discharge

  • test of resistance change over time - number of repetitions performed

    2 weeks, 4 weeks, discharge

Study Arms (2)

Thoracic Mobilization

EXPERIMENTAL

thoracic mobilization in addition to shoulder mobilization plus exercise

Other: thoracic mobilization & shoulder mobilization & exerciseOther: shoulder mobilization & exercise

exercise only

ACTIVE COMPARATOR

shoulder mobilization plus exercise alone

Other: shoulder mobilization & exercise

Interventions

thoracic mobilization & shoulder mobilization & exerciseOTHER
Thoracic Mobilization
shoulder mobilization & exerciseOTHER
Thoracic Mobilizationexercise only

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side

You may not qualify if:

  • Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Physical Therapy Services

Elizabethton, Tennessee, 37643, United States

Location

East Tennessee State University

Johnson City, Tennessee, 37604, United States

Location

Related Publications (1)

  • Wright AA, Donaldson M, Wassinger CA, Emerson-Kavchak AJ. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study. J Man Manip Ther. 2017 Sep;25(4):190-200. doi: 10.1080/10669817.2016.1251377. Epub 2016 Nov 7.

    PMID: 28912631DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexis A Wright, Phd

    High Point University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 20, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

US(3)