Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

Subacromial Impingement Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753271
• Other study ID #: 201208-122
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: August 19, 2015
• Start date: September 2012

Study information

• Verified date: August 2015
• Source: High Point University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Other:
• thoracic mobilization & shoulder mobilization & exercise

• shoulder mobilization & exercise

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Physical Therapy Services	Elizabethton	Tennessee
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
High Point University	University of Illinois at Chicago, Walsh University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shoulder range of motion 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	No
Other	test of resistance change over time - number of repetitions performed	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	2 weeks, 4 weeks, discharge	No
Primary	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	No
Secondary	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	2 weeks, 4 weeks, discharge	No
Secondary	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	2 weeks, 4 weeks, discharge	No