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

NCT05980572 | Completed

• 1 other identifier: Defrozen_Shoulder_App
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Frozen shoulder; App; Exercise

Outcome Measures

Primary Outcomes (1)

• Change shoulder active range of motion in degree

  The range of motion of the shoulder will be assessed using a universal goniometer, which measures the angle of movement between specific bone landmarks. The investigator will evaluate the active range of motion of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, using the goniometer to determine the degrees of movement in each direction. Active range of movement of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, will be measured by goniometer in degree.

  prior to randomization, 4-weeks after interventions and 12-weeks after intervention

Secondary Outcomes (6)

• Change of Shoulder pain by Numeric Rating Scale (NRS)

  prior to randomization, 4-weeks after interventions and 12-weeks after intervention

• Change of Oxford shoulder score (OSS).

  prior to randomization, 4-weeks after interventions and 12-weeks after intervention

• Change of Quick Disability of the Arm, Shoulder and Head (QuickDASH) score

  prior to randomization, 4-weeks after interventions and 12-weeks after intervention

• Selected part of revised Technology Acceptance Model (TAM-2)

  4 weeks after intervention in App intervention group

• System Usability Scale (SUS)

  4 weeks after intervention in App intervention group

Study Arms (2)

App intervention group

EXPERIMENTAL

Patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP intervention group will be guided through the exercises using the mobile app. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.

Drug: Glenohumeral joint and subacromial space triamcinolone injections; Device: App-assisted exercise; Drug: Nonsteroidal anti-inflammatory drugs (aceclofenac)

Conventional group

ACTIVE COMPARATOR

patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The conventional group will be provided with a printed pamphlet illustrating the exercises. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.

Drug: Glenohumeral joint and subacromial space triamcinolone injections; Drug: Nonsteroidal anti-inflammatory drugs (aceclofenac)

Interventions

Glenohumeral joint and subacromial space triamcinolone injections DRUG

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.

App intervention group; Conventional group

App-assisted exercise DEVICE

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.

App intervention group

Nonsteroidal anti-inflammatory drugs (aceclofenac) DRUG

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

App intervention group; Conventional group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility Criteria: Patients with frozen shoulder who are scheduled to receive intra-articular glucocorticosteroid injections, as determined by the physician investigator, will be consecutively enrolled in the study. To be included in the study, patients must meet the following criteria: 1. Unilateral frozen shoulder. 2. Suitability for treatment with intra-articular and subacromial glucocorticosteroid injection. 3. Patients must fulfill the diagnostic criteria for frozen shoulder, as described by Bulgen et al. These criteria include shoulder pain persisting for at least 1 month, sleep disturbance (such as night pain or inability to lie on the affected side), restriction of all active and passive shoulder movements, and a reduction of passive glenohumeral external rotation by at least 50% compared to the unaffected side. 4. Plain radiographs of the shoulder will be obtained to exclude other pathologies. Patients will be excluded from the study if they meet any of the following criteria: 1. Age younger than 20 years old. 2. Bilateral involvement of the shoulder. 3. Secondary frozen shoulder resulting from trauma. 4. History of shoulder joint injections or upper limb surgery within the past month. Presence of rheumatoid arthritis, central nervous system disorders, or cervical radiculopathy. 5. Cognitive disorders or inability to understand exercise instructions. 6. Contraindications for anesthesia or corticosteroid injection. 7. Lack of familiarity with using smartphones.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (37)

• Mezian K, Coffey R, Chang KV. Frozen Shoulder(Archived). 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/

  PMID: 29489251 BACKGROUND

• Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.

  PMID: 15334439 BACKGROUND

• Sarasua SM, Floyd S, Bridges WC, Pill SG. The epidemiology and etiology of adhesive capsulitis in the U.S. Medicare population. BMC Musculoskelet Disord. 2021 Sep 27;22(1):828. doi: 10.1186/s12891-021-04704-9.

  PMID: 34579697 BACKGROUND

• Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.

  PMID: 36075904 BACKGROUND

• Mertens MG, Meert L, Struyf F, Schwank A, Meeus M. Exercise Therapy Is Effective for Improvement in Range of Motion, Function, and Pain in Patients With Frozen Shoulder: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2022 May;103(5):998-1012.e14. doi: 10.1016/j.apmr.2021.07.806. Epub 2021 Aug 21.

  PMID: 34425089 BACKGROUND

• Russell S, Jariwala A, Conlon R, Selfe J, Richards J, Walton M. A blinded, randomized, controlled trial assessing conservative management strategies for frozen shoulder. J Shoulder Elbow Surg. 2014 Apr;23(4):500-7. doi: 10.1016/j.jse.2013.12.026.

  PMID: 24630545 BACKGROUND

• Robinson PM, Norris J, Roberts CP. Randomized controlled trial of supervised physiotherapy versus a home exercise program after hydrodilatation for the management of primary frozen shoulder. J Shoulder Elbow Surg. 2017 May;26(5):757-765. doi: 10.1016/j.jse.2017.01.012. Epub 2017 Mar 18.

  PMID: 28318848 BACKGROUND

• Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.

  PMID: 33326025 BACKGROUND

• Pandey V, Madi S. Clinical Guidelines in the Management of Frozen Shoulder: An Update! Indian J Orthop. 2021 Feb 1;55(2):299-309. doi: 10.1007/s43465-021-00351-3. eCollection 2021 Apr.

  PMID: 33912325 BACKGROUND

• Gleyze P, Clavert P, Flurin PH, Laprelle E, Katz D, Toussaint B, Benkalfate T, Charousset C, Joudet T, Georges T, Hubert L, Lafosse L, Hardy P, Solignac N, Levigne C; French Arthroscopy Society. Management of the stiff shoulder. A prospective multicenter comparative study of the six main techniques in use: 235 cases. Orthop Traumatol Surg Res. 2011 Dec;97(8 Suppl):S167-81. doi: 10.1016/j.otsr.2011.09.004. Epub 2011 Oct 28.

  PMID: 22036993 BACKGROUND

• Hardage J, Peel C, Morris D, Graham C, Brown C, Foushee HR, Braswell J. Adherence to Exercise Scale for Older Patients (AESOP): a measure for predicting exercise adherence in older adults after discharge from home health physical therapy. J Geriatr Phys Ther. 2007;30(2):69-78. doi: 10.1519/00139143-200708000-00006.

  PMID: 18171490 BACKGROUND

• Chen HC, Chuang TY, Lin PC, Lin YK, Chuang YH. Effects of Messages Delivered by Mobile Phone on Increasing Compliance With Shoulder Exercises Among Patients With a Frozen Shoulder. J Nurs Scholarsh. 2017 Jul;49(4):429-437. doi: 10.1111/jnu.12308. Epub 2017 Jun 20.

  PMID: 28632975 BACKGROUND

• Liao CH, Wu YT, Cheng CT, Ooyang CH, Kang SC, Fu CY, Hsu YP, Hsieh CH, Chen CC. An Image-Based Mobile Health App for Postdrainage Monitoring: Usability Study. J Med Internet Res. 2020 Aug 28;22(8):e17686. doi: 10.2196/17686.

  PMID: 32857060 BACKGROUND

• Pfeifer AC, Uddin R, Schroder-Pfeifer P, Holl F, Swoboda W, Schiltenwolf M. Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness. J Clin Med. 2020 Nov 5;9(11):3557. doi: 10.3390/jcm9113557.

  PMID: 33167300 BACKGROUND

• Steiner B, Richter I, Elgert L, Haux R, Wolf KH. Mobile Health Applications for Rehabilitation of Musculoskeletal Diseases of the Shoulder: A Systematic Analysis. Stud Health Technol Inform. 2021 May 24;278:195-202. doi: 10.3233/SHTI210069.

  PMID: 34042894 BACKGROUND

• Elgert L, Steiner B, Saalfeld B, Marschollek M, Wolf KH. Health-Enabling Technologies to Assist Patients With Musculoskeletal Shoulder Disorders When Exercising at Home: Scoping Review. JMIR Rehabil Assist Technol. 2021 Feb 4;8(1):e21107. doi: 10.2196/21107.

  PMID: 33538701 BACKGROUND

• Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.

  PMID: 30441330 BACKGROUND

• Stutz T, Emsenhuber G, Huber D, Domhardt M, Tiefengrabner M, Oostingh GJ, Fotschl U, Matis N, Ginzinger S. Mobile Phone-Supported Physiotherapy for Frozen Shoulder: Feasibility Assessment Based on a Usability Study. JMIR Rehabil Assist Technol. 2017 Jul 20;4(2):e6. doi: 10.2196/rehab.7085.

  PMID: 28729234 BACKGROUND

• Choi Y, Nam J, Yang D, Jung W, Lee HR, Kim SH. Effect of smartphone application-supported self-rehabilitation for frozen shoulder: a prospective randomized control study. Clin Rehabil. 2019 Apr;33(4):653-660. doi: 10.1177/0269215518818866. Epub 2018 Dec 10.

  PMID: 30526016 BACKGROUND

• Bulgen DY, Binder AI, Hazleman BL, Dutton J, Roberts S. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Ann Rheum Dis. 1984 Jun;43(3):353-60. doi: 10.1136/ard.43.3.353.

  PMID: 6742895 BACKGROUND

• Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.

  PMID: 23636125 BACKGROUND

• Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

  PMID: 19297202 BACKGROUND

• Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600.

  PMID: 8682827 BACKGROUND

• Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford shoulder score revisited. Arch Orthop Trauma Surg. 2009 Jan;129(1):119-23. doi: 10.1007/s00402-007-0549-7. Epub 2008 Jan 9.

  PMID: 18183410 BACKGROUND

• Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, Armstrong A, Brooksbank A, Carr A, Cooper C, Dias JJ, Donnelly I, Hewitt C, Lamb SE, McDaid C, Richardson G, Rodgers S, Sharp E, Spencer S, Torgerson D, Toye F; UK FROST Study Group. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020 Oct 3;396(10256):977-989. doi: 10.1016/S0140-6736(20)31965-6.

  PMID: 33010843 BACKGROUND

• Sharma SP, Baerheim A, Kvale A. Passive range of motion in patients with adhesive shoulder capsulitis, an intertester reliability study over eight weeks. BMC Musculoskelet Disord. 2015 Feb 22;16:37. doi: 10.1186/s12891-015-0495-4.

  PMID: 25888419 BACKGROUND

• Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

  PMID: 15866967 BACKGROUND

• Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. doi: 10.1186/1471-2474-7-44.

  PMID: 16709254 BACKGROUND

• Liang HW, Wang HK, Yao G, Horng YS, Hou SM. Psychometric evaluation of the Taiwan version of the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. J Formos Med Assoc. 2004 Oct;103(10):773-9.

  PMID: 15490028 BACKGROUND

• Vorrink SN, Kort HS, Troosters T, Lammers JW. A Mobile Phone App to Stimulate Daily Physical Activity in Patients with Chronic Obstructive Pulmonary Disease: Development, Feasibility, and Pilot Studies. JMIR Mhealth Uhealth. 2016 Jan 26;4(1):e11. doi: 10.2196/mhealth.4741.

  PMID: 26813682 BACKGROUND

• Cho CH, Kim du H, Bae KC, Lee D, Kim K. Proper site of corticosteroid injection for the treatment of idiopathic frozen shoulder: Results from a randomized trial. Joint Bone Spine. 2016 May;83(3):324-9. doi: 10.1016/j.jbspin.2015.06.014. Epub 2016 Feb 10.

  PMID: 26875065 BACKGROUND

• Tallia AF, Cardone DA. Diagnostic and therapeutic injection of the shoulder region. Am Fam Physician. 2003 Mar 15;67(6):1271-8.

  PMID: 12674455 BACKGROUND

• Cho CH, Min BW, Bae KC, Lee KJ, Kim DH. A prospective double-blind randomized trial on ultrasound-guided versus blind intra-articular corticosteroid injections for primary frozen shoulder. Bone Joint J. 2021 Feb;103-B(2):353-359. doi: 10.1302/0301-620X.103B2.BJJ-2020-0755.R1.

  PMID: 33517741 BACKGROUND

• Deng Z, Li Z, Li X, Chen Z, Shen C, Sun X, Shu H, Wu J, Tang K. Comparison of Outcomes of Two Different Corticosteroid Injection Approaches for Primary Frozen Shoulder: A Randomized Controlled Study. J Rehabil Med. 2023 Jan 3;55:jrm00361. doi: 10.2340/jrm.v55.2201.

  PMID: 36597664 BACKGROUND

• Wu T, Song HX, Dong Y, Li JH. Ultrasound-guided versus blind subacromial-subdeltoid bursa injection in adults with shoulder pain: A systematic review and meta-analysis. Semin Arthritis Rheum. 2015 Dec;45(3):374-8. doi: 10.1016/j.semarthrit.2015.05.011. Epub 2015 May 21.

  PMID: 26590864 BACKGROUND

• Antoine Parker C, Ellis R. Effect of Electronic Messaging on Physical Activity Participation among Older Adults. J Aging Res. 2016;2016:6171028. doi: 10.1155/2016/6171028. Epub 2016 May 17.

  PMID: 27293891 BACKGROUND

• Kim BH, Glanz K. Text messaging to motivate walking in older African Americans: a randomized controlled trial. Am J Prev Med. 2013 Jan;44(1):71-5. doi: 10.1016/j.amepre.2012.09.050.

  PMID: 23253653 BACKGROUND

MeSH Terms

Conditions

Bursitis; Alzheimer Disease; Motor Activity

Interventions

Anti-Inflammatory Agents, Non-Steroidal; aceclofenac

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Chih-Chi Chen

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor blind to the arm of the subjects
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: August 8, 2023
• Study Start: September 11, 2022
• Primary Completion: October 20, 2023
• Study Completion: December 31, 2023
• Last Updated: April 3, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)