Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

ID: NCT01753271
Status: Completed
Phase: N/A
Start Date: September 01, 2012
First Submitted: December 11, 2012
Last Updated: August 19, 2015
Results: N/A
Organization: High Point University
Sponsors & Collaborators: High Point University, University of Illinois at Chicago, Walsh University
Location: United States
Conditions: Subacromial Impingement Syndrome
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Subacromial Impingement Syndrome

Other: thoracic mobilization & shoulder mobilization & exercise
Other Names
Other: shoulder mobilization & exercise
Other Names
N/A

Tracking Information

First Submitted DateDecember 11, 2012
Last Update Posted DateAugust 19, 2015
Start DateSeptember 01, 2012
Completion DateN/A
Primary Completion DateJune 01, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Shoulder Pain and Disability Index Change over time [Time Frame: 2 weeks, 4 weeks, discharge]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Numeric Pain Rating Scale change over time [Time Frame: 2 weeks, 4 weeks, discharge]

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

  • Fear Avoidance Beliefs Questionnaire change over time [Time Frame: 2 weeks, 4 weeks, discharge]

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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSubacute Effects of Spinal Mobilization to Treat Subacromial Impingement
Official TitleSubacute Effects of Cervicothoracic Spinal Manipulation in Addition to Shoulder Manual Therapy Plus Exercise Intervention in Individuals With Subacromial Impingement Syndrome: a Randomized, Controlled Clinical Trial Pilot Study
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
20
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Subacromial Impingement Syndrome
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: thoracic mobilization & shoulder mobilization & exercise

Other Names
Other: shoulder mobilization & exercise

Other Names
Study Groups/Cohorts
Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise

exercise only
shoulder mobilization plus exercise alone

Study Arms
Active Comparator exercise only
shoulder mobilization plus exercise alone
Other : shoulder mobilization & exercise

Experimental Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
Other : thoracic mobilization & shoulder mobilization & exercise

Experimental Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
Other : shoulder mobilization & exercise

Arm Intervention/Treatment
Active Comparator exercise only
shoulder mobilization plus exercise alone
Other : shoulder mobilization & exercise
Experimental Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
Other : thoracic mobilization & shoulder mobilization & exercise
Experimental Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
Other : shoulder mobilization & exercise

Recruitment Information

Recruitment Status:Completed
Enrollment20
Completion DateN/A
Eligibility Criteria: Inclusion Criteria:
- 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

Exclusion Criteria:
- Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded
GenderAll
Age18 Years to 50 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01753271
Other Study ID Numbers
201208-122
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
High Point University
Collaborators
University of Illinois at Chicago
Walsh University
Investigators
Principal Investigator
Alexis A Wright, Phd
High Point University