Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by High Point University
Sponsor:
Collaborators:
East Tennessee State University
University of Illinois at Chicago
Physical Therapy Services
Information provided by (Responsible Party):
High Point University
ClinicalTrials.gov Identifier:
NCT01753271
First received: December 11, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Subacromial Impingement Syndrome
Other: thoracic mobilization & shoulder mobilization & exercise
Other: shoulder mobilization & exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by High Point University:

Primary Outcome Measures:
  • Shoulder Pain and Disability Index Change over time [ Time Frame: 2 weeks, 4 weeks, discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks, 4 weeks, discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks


Other Outcome Measures:
  • Shoulder range of motion change over time [ Time Frame: 2 weeks, 4 weeks, discharge ] [ Designated as safety issue: No ]
    Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks

  • test of resistance change over time - number of repetitions performed [ Time Frame: 2 weeks, 4 weeks, discharge ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
Other: thoracic mobilization & shoulder mobilization & exercise Other: shoulder mobilization & exercise
Active Comparator: exercise only
shoulder mobilization plus exercise alone
Other: shoulder mobilization & exercise

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753271

Contacts
Contact: Alexis Wright, Phd, DPT 3368419270 awright@highpoint.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Alicia Emerson Kavchak, PT       aemers2@uic.edu   
Principal Investigator: Alicia Emerson Kavchak, PT         
United States, Tennessee
Physical Therapy Services Recruiting
Elizabethton, Tennessee, United States, 37643
Contact: Craig Wassinger, PhD         
East Tennessee State University Not yet recruiting
Johnson City, Tennessee, United States, 37604
Contact: Craig Wassinger, PhD    423-439-8295    WASSINGER@mail.etsu.edu   
Principal Investigator: Craig Wassinger, PhD         
Sponsors and Collaborators
High Point University
East Tennessee State University
University of Illinois at Chicago
Physical Therapy Services
Investigators
Principal Investigator: Alexis A Wright, Phd High Point University
  More Information

No publications provided

Responsible Party: High Point University
ClinicalTrials.gov Identifier: NCT01753271     History of Changes
Other Study ID Numbers: 201208-122
Study First Received: December 11, 2012
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014