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.
