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IRCT20221030056342N7 IRCT 2025-12-06 Mashhad University of Medical Sciences Investigating the effect of remote rehabilitation in physiotherapy treatment of frozen shoulder patients 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 2025-09-20 anticipated 48 Recruiting https://irct.ir/trial/84955 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Frozen shoulder syndrome. Intervention 1: Individuals in the control group will receive 12 one-hour sessions of treatment as follows: 1. Low-power laser will be applied for 30 seconds to 8 painful points of the shoulder joint capsule with an energy of 1.8 Joules per point. 2. After that, in the second stage, electrical skin stimulation with a frequency of 150 and a current intensity of 25 to 35 mA (at a level of comfort determined by the patient) will be applied for 15 minutes.3. Before performing mobilization and stretching exercises, a hot pack is applied for 15 minutes to increase the flexibility of collagen. 4. The second diagonal flexion pattern in the upper limb in the involved hand along with the Hold-Relax technique will be performed as a 10-second contraction of the antagonist muscle, 5 times per session.5. At the end of each session, individuals in both groups are taught the necessary exercises to exercise at home at least once a day, observing the precautions for each stage of the exercise. Intervention 2: Individuals in the Intervention group will receive 12 one-hour sessions of treatment as follows: 1. Low-power laser will be applied for 30 seconds to 8 painful points of the shoulder joint capsule with an energy of 1.8 Joules per point. 2. After that, in the second stage, electrical skin stimulation with a frequency of 150 and a current intensity of 25 to 35 mA (at a level of comfort determined by the patient) will be applied for 15 minutes.3. Before performing mobilization and stretching exercises, a hot pack is applied for 15 minutes to increase the flexibility of collagen. 4. The second diagonal flexion pattern in the upper limb in the involved hand along with the Hold-Relax technique will be performed as a 10-second contraction of the antagonist muscle, 5 times per session.5. At the end of each session, individuals in both groups are taught the necessary exercises to exercise at home at least once a day, observing the precautions for each stage of the exercise. The intervention group receives the same exercises and care recommendations in the form of a mobile application. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is All the results of the present research will be available to other researchers in the form of printed articles.
public Afsaneh Zeinalzadeh
Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Kharazmi Building, Faculty of Paramedical and Rehabilitation Sciences, Department of Physiotherapy
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 sps.Dean@mums.ac.ir Mashhad University of Medical Sciences scientific Salman Nazary-moghadam
Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Kharazmi Building, Faculty of Paramedical and Rehabilitation Sciences, Department of Physiotherapy
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 sps.Dean@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Limitation in both active and passive range of motion shoulder pain for at least 4 weeks access to a mobile phone capable of installing the tele-rehabilitation app 18 years 70 years Both Bilateral diagnosis of frozen shoulder Frozen shoulder may be secondary to trauma (fracture or dislocation) or secondary to systemic problems (rheumatoid arthritis) cervical radiculopathy history of shoulder surgery Not able to work with the application M75.0 Adhesive capsulitis of shoulder Treatment - Other Treatment - Other Individuals in the control group will receive 12 one-hour sessions of treatment as follows: 1. Low-power laser will be applied for 30 seconds to 8 painful points of the shoulder joint capsule with an energy of 1.8 Joules per point. 2. After that, in the second stage, electrical skin stimulation with a frequency of 150 and a current intensity of 25 to 35 mA (at a level of comfort determined by the patient) will be applied for 15 minutes.3. Before performing mobilization and stretching exercises, a hot pack is applied for 15 minutes to increase the flexibility of collagen. 4. The second diagonal flexion pattern in the upper limb in the involved hand along with the Hold-Relax technique will be performed as a 10-second contraction of the antagonist muscle, 5 times per session.5. At the end of each session, individuals in both groups are taught the necessary exercises to exercise at home at least once a day, observing the precautions for each stage of the exercise. Individuals in the Intervention group will receive 12 one-hour sessions of treatment as follows: 1. Low-power laser will be applied for 30 seconds to 8 painful points of the shoulder joint capsule with an energy of 1.8 Joules per point. 2. After that, in the second stage, electrical skin stimulation with a frequency of 150 and a current intensity of 25 to 35 mA (at a level of comfort determined by the patient) will be applied for 15 minutes.3. Before performing mobilization and stretching exercises, a hot pack is applied for 15 minutes to increase the flexibility of collagen. 4. The second diagonal flexion pattern in the upper limb in the involved hand along with the Hold-Relax technique will be performed as a 10-second contraction of the antagonist muscle, 5 times per session.5. At the end of each session, individuals in both groups are taught the necessary exercises to exercise at home at least once a day, observing the precautions for each stage of the exercise. The intervention group receives the same exercises and care recommendations in the form of a mobile application. Score of Shoulder Pain and Disability Index Questionnaire. Timepoint: Immediately before and after treatment. Method of measurement: The SPADI questionnaire is used to assess pain and disability in patients with shoulder disorders. The questionnaire consists of 13 questions in two separate sections: pain (5 items) and disability (8 items). The total score ranges from 0 to 100, with higher scores indicating greater pain and disability. Score of Visual Analogue Scale. Timepoint: Immediately before and after treatment. Method of measurement: In this scale, there is a 10 cm horizontal line segment, the left end of which corresponds to the absence of pain and the other end corresponds to the most severe pain that the person experiences. The distance between the left side and the marker is calculated in centimeters and is calculated as the intensity of the pain. Range of motion. Timepoint: Immediately before and after treatment. Method of measurement: To examine the range of motion of the shoulder joint, a goniometer will be used in the supine position based on Kelley guidelines. Score of 12 Item Short Form Survey Quality of Life Questionnaire. Timepoint: Immediately before and after treatment. Method of measurement: It is a 12-question questionnaire and a shorter version of the 36SF- which is divided into two main sections: physical and mental health. A higher score indicates a better quality of life and a lower score indicates a lower quality of life. Quick Disabilities of Arm, Shoulder, and Hand Questionnaire. Timepoint: Immediately before and after treatment. Method of measurement: It is an 11-question questionnaire that assesses the degree of disability in daily activities, limitations in work and recreational activities, the degree of pain, and the psychological impact of the condition. Scores on this questionnaire range from 0 to 100. Higher scores indicate greater disability, and lower scores indicate less disability. Score of Global Rating Scale. Timepoint: Immediately before and after treatment. Method of measurement: The scale is 11 points, ranging from -5 (much worse) to 0 (no change) and +5 (much better). The patient is asked to rate the change in the shoulder following the treatment plan. Mashhad University of Medical Sciences Approved 2025-04-26 Ethics Committee of Mashhad University of Medical Sciences Mashhad, at the end of Shahid Fakuri Blvd, between Shahid Al Shahidi Square and Shahid Javan Square of Mashhad Medical Sciences, Knowledge and Health Village, Central Organization of Knowledge Mashhad Razavi Khorasan Iran (Islamic Republic of)