Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis
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|ClinicalTrials.gov Identifier: NCT03049787|
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2017
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adhesive Capsulitis||Other: Home Exercise Protocol Other: Physical Therapy Protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: home exercise
For the home exercise protocol alone arm, subjects will be given an experimental home exercise program and study team will demonstrate the exercises in the clinic and will direct the subjects to perform the exercises 1-2 times daily until symptom resolution.
Other: Home Exercise Protocol
Home exercise therapy protocol given to patient to be completed at home.
Active Comparator: physical therapy
Patients will be prescribed routine physical therapy protocol where they will see a physical therapist twice a week and will be instructed by the physical therapist to perform physical therapy exercises at home daily until symptom resolution, as is the routine practice.
Other: Physical Therapy Protocol
Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.
- Change in Shoulder Pain and Disability Index(SPADI) [ Time Frame: 6 months compared to baseline score ]shoulder pain and disability index to evaluate shoulder pain and function
- Change in Range of Motion (ROM) [ Time Frame: 6 months compared to baseline score ]evaluate range of motion
- Change in Sane Normal and Pain Visual Analogue Score (SANE) [ Time Frame: 6 months compared to baseline score ]Subjective shoulder score to determine shoulder pain/function
- Change in Mental Health Index- 5 (MHI-5) [ Time Frame: 6 months compared to baseline score ]Mental Health Index- 5 to determine patient mental health status
- Change in Short Form- 36 (SF-36) [ Time Frame: 6 months compared to baseline score ]Short Form Survey- 36 to determine general overall health for patient
- Change in Visual Analog Scale Pain (VAS-Pain) [ Time Frame: 6 months compared to baseline score ]Visual analog scale- pain to assess shoulder pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049787
|Principal Investigator:||Xinning Li, MD||Boston Medical Center|