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

NCT ID: NCT03049787

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-07-30

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.

Conditions

Adhesive Capsulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Home Exercise Protocol

Intervention Type: OTHER

Home exercise therapy protocol given to patient to be completed at home.

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy Protocol

Intervention Type: OTHER

Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.

Interventions

Home Exercise Protocol

Home exercise therapy protocol given to patient to be completed at home.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinning Li, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Other Identifiers

H-32842

Identifier Type: -

Identifier Source: org_study_id