Formal Physical Therapy (PT) vs. Home PT for Adhesive Capsulitis

Not Applicable

Withdrawn

• Conditions: Adhesive Capsulitis
• Interventions: Other: Physical Therapy Protocol; Other: Home Exercise Protocol

• Registration Number: NCT03049787
• Lead Sponsor: Boston Medical Center

Brief Summary

This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-01-07
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-10
• Study Start: 2022-06
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Clinical Diagnosis of Adhesive Capsulitis (limited range of motion)
2. Given glenohumeral and subacromial injection as part of standard care.
3. Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient)
4. English speaking
5. 18 years of age or greater

Exclusion Criteria

1. Prior glenohumeral or subacromial corticosteroid injection within 6 months
2. Prior ipsilateral shoulder surgery
3. Current prescription (narcotic) pain medication use
4. Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy)
5. Cervical radiculopathy
6. Full-thickness rotator cuff tear
7. Calcific Tendinopathy (past or present)
8. Advanced Stage osteoarthritis as seen on radiograph
9. Past/present ipsilateral shoulder fracture
10. Women that may be pregnant or nursing (self report)

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy	Physical Therapy 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.
home exercise	Home Exercise Protocol	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.

Primary Outcome Measures

Name	Time	Method
Change in Shoulder Pain and Disability Index(SPADI)	6 months compared to baseline score	shoulder pain and disability index to evaluate shoulder pain and function

Secondary Outcome Measures

Name	Time	Method
Change in Sane Normal and Pain Visual Analogue Score (SANE)	6 months compared to baseline score	Subjective shoulder score to determine shoulder pain/function
Change in Range of Motion (ROM)	6 months compared to baseline score	evaluate range of motion
Change in Mental Health Index- 5 (MHI-5)	6 months compared to baseline score	Mental Health Index- 5 to determine patient mental health status
Change in Visual Analog Scale Pain (VAS-Pain)	6 months compared to baseline score	Visual analog scale- pain to assess shoulder pain
Change in Short Form- 36 (SF-36)	6 months compared to baseline score	Short Form Survey- 36 to determine general overall health for patient