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

The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis

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

Study Overview

• Status: Withdrawn
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Other: Home Exercise Protocol; Other: Physical Therapy Protocol

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Xinning Li, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: physical therapy; home exercise; adhesive capsulitis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: H-32842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No