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

Adhesive Capsulitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03049787
• Other study ID #: H-32842
• Status: Withdrawn
• Phase: N/A
• Start date: June 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: June 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Other:
• Home Exercise Protocol
Home exercise therapy protocol given to patient to be completed at home.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shoulder Pain and Disability Index(SPADI)	shoulder pain and disability index to evaluate shoulder pain and function	6 months compared to baseline score
Secondary	Change in Range of Motion (ROM)	evaluate range of motion	6 months compared to baseline score
Secondary	Change in Sane Normal and Pain Visual Analogue Score (SANE)	Subjective shoulder score to determine shoulder pain/function	6 months compared to baseline score
Secondary	Change in Mental Health Index- 5 (MHI-5)	Mental Health Index- 5 to determine patient mental health status	6 months compared to baseline score
Secondary	Change in Short Form- 36 (SF-36)	Short Form Survey- 36 to determine general overall health for patient	6 months compared to baseline score
Secondary	Change in Visual Analog Scale Pain (VAS-Pain)	Visual analog scale- pain to assess shoulder pain	6 months compared to baseline score