An interventional study of Home Exercise Protocol and Physical Therapy Protocol in Adhesive Capsulitis, sponsored by Boston Medical Center. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment
This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.
Patients with adhesive capsulitis receive a glenohumeral and subacromial injection routinely for treatment. In addition, the patients are routinely prescribed physical therapy with a home exercise component. The purpose of this study is to evaluate whether home exercise alone is an alternative option to physical therapy. Patients will be approached about the study after they have agreed to receive a glenohumeral and subacromial injection per standard of care for their clinical treatment. The hypothesis being tested is whether home exercise is alone is as beneficial for pain relief, restoration of range of motion, and improvement in shoulder disability from adhesive capsulitis as physical therapy. Additionally sex differences, diabetes mellitus, endocrine, and mental health histories will be noted.
417 studies on the registry are indexed under Bursitis; 112 are open to participants now.
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Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
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Exclusion Criteria:
Past/present physical therapy treatment will be documented, but will not be considered an exclusion factor. The reasoning behind this is that the physical therapy likely was not properly targeting the adhesive capsulitis for the patient to arrive in an orthopaedic clinic and is likely at a similar starting point to most other patients regardless of previous physical therapy. All patients currently enrolled in physical therapy will be assigned to either our physical therapy or home exercise program.
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
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
Home exercise therapy protocol given to patient to be completed at home.
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)
shoulder pain and disability index to evaluate shoulder pain and function
Time frame: 6 months compared to baseline score
Change in Range of Motion (ROM)
evaluate range of motion
Time frame: 6 months compared to baseline score
Change in Sane Normal and Pain Visual Analogue Score (SANE)
Subjective shoulder score to determine shoulder pain/function
Time frame: 6 months compared to baseline score
Change in Mental Health Index- 5 (MHI-5)
Mental Health Index- 5 to determine patient mental health status
Time frame: 6 months compared to baseline score
Change in Short Form- 36 (SF-36)
Short Form Survey- 36 to determine general overall health for patient
Time frame: 6 months compared to baseline score
Change in Visual Analog Scale Pain (VAS-Pain)
Visual analog scale- pain to assess shoulder pain
Time frame: 6 months compared to baseline score
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2022.
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This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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