Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder

Summary

Abstract

Introduction Frozen shoulder is a common musculoskeletal disorder with reported lifetime prevalence to be 2%\~5% in the general population. Patients with frozen shoulders present with chronic pain and limited range of motion of affected shoulder and often cause an adverse impact on their daily activities and working ability. Shoulder exercises had been proven to be effective in treatment of frozen shoulders and the effects were even better after intraarticular corticosteroid injection. Strategies to enhance home exercise for patients with frozen shoulders are essential.

Objective To compare the effects of home exercises delivered by a newly developed app named Defrozen app with that by convention home exercise for frozen shoulder patients after intra-articular corticosteroid injection.

Methods and analysis This is a randomized, controlled, assessor-blinded clinical trial. Seventy-eight individuals diagnosed with frozen shoulders will be randomly divided into two groups. The primary outcome will be shoulder passive range of motion (measured with a universal goniometer). The secondary outcomes will include , shoulder pain evaluated by 11-point numeric rating scale , Oxford shoulder score and Disabilities of the arm, shoulder and hand questionnaire. Feasibility of the app includes including Technology Acceptance Model (TAM-2), System Usability Scale (SUS) and Usability, Satisfaction and Ease of Use (USE) questionnaire . The treatment will be conducted for 6 months (Defrozen app home exercise x conventional home exercise by instructions from printed pamphlets).All participants will receive outcome measurements assessment prior to randomization , 4 weeks , 12 weeks after injections interventions. Feasibility will be evaluated 4 weeks after intervention in the Defrozen app group.

Ethics and dissemination The study protocol was approved by the Institutional Review Board. The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.

Conditions

• Frozen Shoulder

Interventions

DRUG

Glenohumeral joint and subacromial space triamcinolone injections

All patients will receive both glenohumeral joint and subacromial space injections. The injections will consist of a solution containing 1 ml of 40 mg/ml triamcinolone acetonide and 1 ml of 1% lidocaine in each site. The glenohumeral joint injection will be performed blindly using an anterior approach. The needle will be inserted medially to the head of the humerus, located approximately 1 cm lateral to the coracoid process, and directed posteriorly at a slight superior and lateral angle. Patients will be educated on how to perform the 7 sets of frozen shoulder exercise. Subjects will be advised to perform all the exercises to a point that they may feel tightness but not painful and hold to the point for 2-3 seconds.

DEVICE

App-assisted exercise

Patients will be educated on how to perform the 7 sets of frozen shoulder exercise. Subjects will be advised to perform all the exercises to a point that they may feel tightness but not painful and hold to the point for 2-3 seconds. Then the APP group will suggest performing the exercise from APP education The APP intervention group will be guided through the exercises using the mobile app, while the conventional group will be provided with a printed pamphlet illustrating the exercises.. Each set exercise will have 10 repetitions and investigators recommend 4 sessions per day.

DRUG

Nonsteroidal anti-inflammatory drugs (aceclofenac)

All patients will be prescribed two weeks of nonsteroidal anti-inflammatory drugs (aceclofenac) .

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Chih-Chi Chen · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-11

Primary Completion

2023-10-20

Completion

2023-12-31

Countries

• Taiwan

Study Locations