Back to resultsSubacute Effects of Spinal Mobilization to Treat Subacromial Impingement
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
thoracic mobilization & shoulder mobilization & exercise
shoulder mobilization & exercise
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome
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
Sites / Locations
- University of Illinois at Chicago
- Physical Therapy Services
- East Tennessee State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thoracic Mobilization
exercise only
Arm Description
thoracic mobilization in addition to shoulder mobilization plus exercise
shoulder mobilization plus exercise alone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Numeric Pain Rating Scale change over time
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
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Full Information
NCT ID
NCT01753271
First Posted
December 11, 2012
Last Updated
August 19, 2015
Sponsor
High Point University
Collaborators
University of Illinois at Chicago, Walsh University
1. Study Identification
Unique Protocol Identification Number
NCT01753271
Brief Title
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
Official Title
Subacute 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point University
Collaborators
University of Illinois at Chicago, Walsh University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracic Mobilization
Arm Type
Experimental
Arm Description
thoracic mobilization in addition to shoulder mobilization plus exercise
Arm Title
exercise only
Arm Type
Active Comparator
Arm Description
shoulder mobilization plus exercise alone
Intervention Type
Other
Intervention Name(s)
thoracic mobilization & shoulder mobilization & exercise
Intervention Type
Other
Intervention Name(s)
shoulder mobilization & exercise
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index Change over time
Description
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Time Frame
2 weeks, 4 weeks, discharge
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale change over time
Description
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Time Frame
2 weeks, 4 weeks, discharge
Title
Fear Avoidance Beliefs Questionnaire change over time
Description
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Time Frame
2 weeks, 4 weeks, discharge
Other Pre-specified Outcome Measures:
Title
Shoulder range of motion change over time
Description
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Time Frame
2 weeks, 4 weeks, discharge
Title
test of resistance change over time - number of repetitions performed
Description
The test is performed by asking the patient to hold the shoulder at 90 degrees of shoulder flexion and follow a 20cm wide spiral using their affected arm. The patient is asked to complete as many spiral movements as possible until stopped secondary to pain. The maximum number of repetitions to be performed is 20.
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Time Frame
2 weeks, 4 weeks, discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis A Wright, Phd
Organizational Affiliation
High Point University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Physical Therapy Services
City
Elizabethton
State/Province
Tennessee
ZIP/Postal Code
37643
Country
United States
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28912631
Citation
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.
Results Reference
derived
Learn more about this trial
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
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