Effectiveness of augmented tele-rehabilitation based on mobile application to routine physical therapy on pain, range of motion, disability and quality of life in patients with adhesive capsulitis: Randomized controlled trial

Investigating the effect of adding telerehabilitation to routine physiotherapy on pain, range of motion, disability, and quality of life outcomes in frozen shoulder patients

A clinical trial with a control group, with double-blind, randomized parallel groups, phase 3 was conducted on 24 patients. https://www.sealedenvelope.com/simple-randomiser/v1/lists was used for randomization

Both groups receive 12 physiotherapy sessions over 4 weeks, including hot pack, TENS, low-level laser therapy, joint mobilization, and PNF techniques. The intervention group will also use a mobile app providing guided home exercises, which adjusts difficulty based on patient feedback. The app includes instructional videos, timers, and daily questionnaires. Sessions last approximately 60 minutes. The research location are at the The special clinic of Ghaem Hospital and Comprehensive Rehabilitation Center in Mashhad, on Parastar Street.

Inclusion criteria: Limited active and passive shoulder range of motion, history of shoulder pain for at least 4 weeks, requirements to download and install the application Exclusion criteria: Bilateral involvement, history of trauma, surgery, or infection

The intervention group will include patients who receive the mobile app in addition to conventional physiotherapy. The comparison group will include patients who receive conventional physiotherapy only.

Score of Shoulder Pain and Disability Index questionnaire

In this study, the unit block randomization method is used. For this method, the size of each block must first be determined (for example, a block of four). Then, a list of blocks is written and numbers are assigned to them (AABB(1)- ABAB(2)- ABBA(3)- BBAA(4)- BABA(5)- BAAB(6)), then random numbers between one and six are selected (for example, 1 4 5, etc.), and finally, the treatment allocation list is determined based on the previous random numbers (… AABB-BBAA-BABA-).} The randomization sequence will be prepared with the help of the website www.sealedenvelope.com. The steps for allocating individuals to the groups are as follows: Preparation of Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE): Each position in the allocation list (e.g., the first position, which is A; the second, which is A; the third, which is B; etc.) is placed inside an opaque, sealed envelope. Only a serial number (1, 2, 3, ...) is marked on the outside of each envelope. Randomization at the Time of Each Individual's Enrollment: After verifying the eligibility and obtaining informed consent from each participant, a researcher who is directly involved with the participant (and is typically unaware of the envelope's contents) opens the envelope with the lowest available serial number. Group Allocation: The content inside the envelope (the letter A for the intervention group or B for the control group) determines which group that specific participant is assigned to.

Patients will be divided into two groups, intervention and control, by the sample allocator from the set of envelopes and according to the order indicated by the number on the back of the envelopes. The sample allocator, who will be unaware of the coding method, will be blind to the outcome assessor before treatment and then in the fourth week of treatment. The therapist will also be blind.