Frozen ShoulderNCT05980572
Effects of App-assisted Home Exercise Program in Patients With Frozen Shoulder
A study testing Glenohumeral joint and subacromial space triamcinolone injections, App-assisted exercise and Nonsteroidal anti-inflammatory drugs (aceclofenac) in people with Frozen Shoulder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Glenohumeral joint and subacromial space triamcinolone injections, App-assisted exercise and Nonsteroidal anti-inflammatory drugs (aceclofenac)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- Unilateral frozen shoulder.
- Suitability for treatment with intra-articular and subacromial glucocorticosteroid injection.
- 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.
- 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:
- Age younger than 20 years old.
- Bilateral involvement of the shoulder.
- Secondary frozen shoulder resulting from trauma.
- History of shoulder joint injections or upper limb surgery within the past month. Presence of rheumatoid arthritis, central nervous system disorders, or cervical radiculopathy.
- Cognitive disorders or inability to understand exercise instructions.
- Contraindications for anesthesia or corticosteroid injection.
- Lack of familiarity with using smartphones.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
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.
Read more
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.
Read the detailed description
The primary objective of this study is to test the hypothesis that a 12-week frozen shoulder exercise program delivered through the mobile app will result in greater improvement in shoulder range of motion compared to the control group. The control group will receive conventional home exercises provided on paper for patients with frozen shoulder after undergoing intra-articular corticosteroid injection.The secondary objective is to assess the differences in range of motion and functional outcomes between the two groups of patients. Additionally, the feasibility and acceptability of the Defrozen-App to these patients will be evaluated.
This study will employ a prospective, two-armed, assessor-blinded superiority randomized controlled trial design to compare two parallel groups of patients with primary frozen shoulder. The study was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for planning interventional trials. The trial results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
This study will be conducted in the northern branch of a medical system, which includes three hospitals located in northern Taiwan. The trial is registered [provide registration number or leave it blank if not available]. The recruitment of patients will take place in the clinic of the Department of Physical Medicine and Rehabilitation at Chang Gung Memorial Hospital, Taipei, Linko, and Taoyuan branches.
A Mobile Phone App for Demonstrating Home Exercises for Frozen Shoulder:
The Defrozen app is designed to provide simple home exercise programs for patients with frozen shoulders. It includes various features such as a training mode with exercise demonstrations, an exercise calendar, and pain evaluation.The main screen of the app displays exercise videos that are demonstrated by one of our researchers. It consists of seven sets of exercises specifically selected by physicians and a physiotherapist in our team. These exercises include Finger Walk for shoulder flexion and abduction, self-stretching exercises for shoulder external rotation and pectoral muscles, and crossover arm stretch for shoulder adduction. Additionally, towel exercises for shoulder extension and internal rotation are included. Each set of exercises consists of 10 repetitions, and we recommend performing four sessions per day. The total exercise time for one session is approximately 8 minutes. We encourage users to follow the exercise demonstrations provided in the app.After completing the exercise mode, the app prompts the patient to indicate whether they have completed the exercise and record their current pain intensity on a scale ranging from 0 to 10 . The app then transitions to the calendar mode, which displays the number of exercise sessions completed on that day and reminds the patient of the remaining sessions to be completed.
Procedures:
Participants will be recruited from the clinics of physical medicine and rehabilitation in a medical center located in northern Taiwan. Detailed information about the study will be provided to all eligible patients, and written informed consent will be obtained from each participant. All study visits will take place at a clinical laboratory near the clinics.
The assessor will collect baseline data from participants prior to randomization. Follow-up assessments will be conducted at two time points: 4 weeks after the interventions and 12 weeks after the interventions. Feasibility of the interventions will be evaluated only after the 4-week intervention period.
Random Allocation:
Random allocation of participants will be conducted using computer-generated random numbers in a 1:1 ratio. This process will be performed by one of the authors who is independent of the screening, patient recruitment, clinical care, and data collection. Subjects will be randomly assigned to either the Defrozen App group or the conventional group, ensuring equal allocation between the two groups.
The generated random number list will be placed into sequentially numbered, opaque, and sealed envelopes. These envelopes will be securely stored by the researcher responsible for allocation. Once a subject has been confirmed as eligible and has provided informed consent, the envelope corresponding to their sequential order will be opened to reveal their group allocation.
Blinding:
Participant allocation and follow-up arrangements will be overseen by a clinical researcher who will not be blinded to the participants' group assignments. However, to minimize bias, outcome measure assessments will be conducted by a physician from the study team who will be unaware of the participants' intervention groups.
Interventions In this study, all patients, regardless of their group allocation, will receive both glenohumeral joint and subacromial space injections. This decision is based on previous research that has suggested a synergistic effect of combination injections in increasing joint internal rotation angle. (Proper site of corticosteroid injection for the treatment of idiopathic frozen shoulder: Results from a randomized trial)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.Previous studies have suggested that blind anterior glenohumeral joint injection yields comparable pain and functional outcomes to ultrasound-guided injection. Additionally, the anterior approach has shown better pain control and improved functional activity recovery in the early stages of primary frozen shoulder compared to the posterior approach.
For the subacromial injection, ultrasound guidance will be employed to potentially achieve greater clinical improvement in shoulder pain compared to blind injection.Following the injections, patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP 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 of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day. Additionally, all patients will be prescribed two weeks of nonsteroidal anti-inflammatory drugs (aceclofenac) to manage pain and inflammation.
- Conditions
- Frozen Shoulder
- Being tested
- Glenohumeral joint and subacromial space triamcinolone injections, App-assisted exercise, Nonsteroidal anti-inflammatory drugs (aceclofenac)
- Keywords
- Frozen shoulder, App, Exercise
- Medical subject headings
- Bursitis, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenohumeral joint and subacromial space triamcinolone injectionsDrug
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-assisted exerciseDevice
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.
Nonsteroidal anti-inflammatory drugs (aceclofenac)Drug
All patients will be prescribed two weeks of nonsteroidal anti-inflammatory drugs (aceclofenac) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Glenohumeral joint and subacromial space triamcinolone injections; Drug: Nonsteroidal anti-inflammatory drugs (aceclofenac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Secondary outcomes (6)
Change of Shoulder pain by Numeric Rating Scale (NRS)
To assess shoulder pain, investigators will utilize an 11-point NRS. Patients will be informed that a score of 0 represents no pain, while a score of 10 indicates the highest level of pain.
Measured: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Change of Oxford shoulder score (OSS).
A patient-rated outcome measure of shoulder pain and function in patients with shoulder pain. OSS has twelve questions with five possible responses ranging from 0 (worst) to 4 (best).
Measured: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Change of Quick Disability of the Arm, Shoulder and Head (QuickDASH) score
The QuickDASH is a modified version of the original 30-item Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, consisting of 11 items. A minimum of 10 items must be completed by the participant. Each item has five response options.The total QuickDASH score ranges from 0 (indicating no disability) to 100 (representing the most severe disability)
Measured: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Selected part of revised Technology Acceptance Model (TAM-2)
The selected part of revised Technology Acceptance Model(TAM-2) including intention to use, perceived usefulness and perceived ease of use. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree."
Measured: 4 weeks after intervention in App intervention group
System Usability Scale (SUS)
he SUS is a standardized questionnaire that consists of ten statements related to the usability of the application. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree."
Measured: 4 weeks after intervention in App intervention group
Usability, Satisfaction and Ease of Use (USE) questionnaire
The questionnaire consists of four statements related to the system or application being evaluated. Participants will be asked to rate their agreement with each statement on a five-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree."
Measured: 4 weeks after intervention in App intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start11 Sep 2022
- Primary completion20 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Chi ,Chen, Chang Gung Memorial Hospital
- Investigators
- Chih-Chi Chen, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980572
- Sponsor's protocol ID
- Defrozen_Shoulder_App
- Status last verified
- Aug 2022
- First submitted
- 21 Nov 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
PubMed 29489251Walker-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.
PubMed 15334439Sarasua 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.
PubMed 34579697Millar 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.
PubMed 36075904Mertens 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.
PubMed 34425089Russell 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.
PubMed 24630545Robinson 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.
PubMed 28318848Challoumas 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.
PubMed 33326025Pandey 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.
PubMed 33912325Gleyze 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.
PubMed 22036993Hardage 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.
PubMed 18171490Chen 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.
PubMed 28632975Liao 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.
PubMed 32857060Pfeifer 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.
PubMed 33167300Steiner 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.
PubMed 34042894
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05980572
- Acronym / sponsor ID
- Defrozen_Shoulder_App
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, App, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to test the hypothesis that a 12-week frozen shoulder exercise program delivered through the mobile app will result in greater improvement in shoulder range of motion compared to the control group. The control group will receive conventional home exercises provided on paper for patients with frozen shoulder after undergoing intra-articular corticosteroid injection.The secondary objective is to assess the differences in range of motion and functional outcomes between the two groups of patients. Additionally, the feasibility and acceptability of the Defrozen-App to these patients will be evaluated.
This study will employ a prospective, two-armed, assessor-blinded superiority randomized controlled trial design to compare two parallel groups of patients with primary frozen shoulder. The study was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for planning interventional trials. The trial results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
This study will be conducted in the northern branch of a medical system, which includes three hospitals located in northern Taiwan. The trial is registered [provide registration number or leave it blank if not available]. The recruitment of patients will take place in the clinic of the Department of Physical Medicine and Rehabilitation at Chang Gung Memorial Hospital, Taipei, Linko, and Taoyuan branches.
A Mobile Phone App for Demonstrating Home Exercises for Frozen Shoulder:
The Defrozen app is designed to provide simple home exercise programs for patients with frozen shoulders. It includes various features such as a training mode with exercise demonstrations, an exercise calendar, and pain evaluation.The main screen of the app displays exercise videos that are demonstrated by one of our researchers. It consists of seven sets of exercises specifically selected by physicians and a physiotherapist in our team. These exercises include Finger Walk for shoulder flexion and abduction, self-stretching exercises for shoulder external rotation and pectoral muscles, and crossover arm stretch for shoulder adduction. Additionally, towel exercises for shoulder extension and internal rotation are included. Each set of exercises consists of 10 repetitions, and we recommend performing four sessions per day. The total exercise time for one session is approximately 8 minutes. We encourage users to follow the exercise demonstrations provided in the app.After completing the exercise mode, the app prompts the patient to indicate whether they have completed the exercise and record their current pain intensity on a scale ranging from 0 to 10 . The app then transitions to the calendar mode, which displays the number of exercise sessions completed on that day and reminds the patient of the remaining sessions to be completed.
Procedures:
Participants will be recruited from the clinics of physical medicine and rehabilitation in a medical center located in northern Taiwan. Detailed information about the study will be provided to all eligible patients, and written informed consent will be obtained from each participant. All study visits will take place at a clinical laboratory near the clinics.
The assessor will collect baseline data from participants prior to randomization. Follow-up assessments will be conducted at two time points: 4 weeks after the interventions and 12 weeks after the interventions. Feasibility of the interventions will be evaluated only after the 4-week intervention period.
Random Allocation:
Random allocation of participants will be conducted using computer-generated random numbers in a 1:1 ratio. This process will be performed by one of the authors who is independent of the screening, patient recruitment, clinical care, and data collection. Subjects will be randomly assigned to either the Defrozen App group or the conventional group, ensuring equal allocation between the two groups.
The generated random number list will be placed into sequentially numbered, opaque, and sealed envelopes. These envelopes will be securely stored by the researcher responsible for allocation. Once a subject has been confirmed as eligible and has provided informed consent, the envelope corresponding to their sequential order will be opened to reveal their group allocation.
Blinding:
Participant allocation and follow-up arrangements will be overseen by a clinical researcher who will not be blinded to the participants' group assignments. However, to minimize bias, outcome measure assessments will be conducted by a physician from the study team who will be unaware of the participants' intervention groups.
Interventions In this study, all patients, regardless of their group allocation, will receive both glenohumeral joint and subacromial space injections. This decision is based on previous research that has suggested a synergistic effect of combination injections in increasing joint internal rotation angle. (Proper site of corticosteroid injection for the treatment of idiopathic frozen shoulder: Results from a randomized trial)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.Previous studies have suggested that blind anterior glenohumeral joint injection yields comparable pain and functional outcomes to ultrasound-guided injection. Additionally, the anterior approach has shown better pain control and improved functional activity recovery in the early stages of primary frozen shoulder compared to the posterior approach.
For the subacromial injection, ultrasound guidance will be employed to potentially achieve greater clinical improvement in shoulder pain compared to blind injection.Following the injections, patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP 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 of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day. Additionally, all patients will be prescribed two weeks of nonsteroidal anti-inflammatory drugs (aceclofenac) to manage pain and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App intervention group | Experimental | Drug: Glenohumeral joint and subacromial space triamcinolone injections, Device: App-assisted exercise, Drug: Nonsteroidal anti-inflammatory drugs (aceclofenac)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. |
| Conventional group | Active comparator | Drug: Glenohumeral joint and subacromial space triamcinolone injections, Drug: Nonsteroidal anti-inflammatory drugs (aceclofenac)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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glenohumeral joint and subacromial space triamcinolone injectionsAll 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. | Drug | App intervention group, Conventional group |
| App-assisted exercisePatients 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. | Device | App intervention group |
| Nonsteroidal anti-inflammatory drugs (aceclofenac)All patients will be prescribed two weeks of nonsteroidal anti-inflammatory drugs (aceclofenac) . | Drug | App intervention group, Conventional group |
Primary outcome
Change shoulder active range of motion in degree
Time frame: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
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.
6 secondary outcomes
Change of Shoulder pain by Numeric Rating Scale (NRS)
Time frame: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Change of Oxford shoulder score (OSS).
Time frame: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Change of Quick Disability of the Arm, Shoulder and Head (QuickDASH) score
Time frame: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
Selected part of revised Technology Acceptance Model (TAM-2)
Time frame: 4 weeks after intervention in App intervention group
System Usability Scale (SUS)
Time frame: 4 weeks after intervention in App intervention group
Usability, Satisfaction and Ease of Use (USE) questionnaire
Time frame: 4 weeks after intervention in App intervention group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 29489251Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
- Background: PubMed 15334439Walker-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.
- Background: PubMed 34579697Sarasua 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.
- Background: PubMed 36075904Millar 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.
- Background: PubMed 34425089Mertens 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.
- Background: PubMed 24630545Russell 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.
- Background: PubMed 28318848Robinson 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.
- Background: PubMed 33326025Challoumas 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.
- Background: PubMed 33912325Pandey 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.
- Background: PubMed 22036993Gleyze 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.
- Background: PubMed 18171490Hardage 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.
- Background: PubMed 28632975Chen 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.
- Individual participant dataSharing planned: No
Related trials for Frozen Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Chi Chen principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glenohumeral joint and subacromial space triamcinolone injections, App-assisted exercise and Nonsteroidal anti-inflammatory drugs (aceclofenac) in people with Frozen Shoulder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change shoulder active range of motion in degree (time frame: prior to randomization, 4-weeks after interventions and 12-weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980572, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.