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IRCT20251118068043N1 IRCT 2025-11-22 shahid beheshti university of Tehran Comparing the effects of massage and nerve stretching exercises on symptoms of pianists with carpal tunnel syndrome Comparison of The Effect of Six Weeks of Self-Massage and Nerve Gliding Exercise on Wrist Pain and Functional Disability of Piano Players with Carpal Tunnel Syndrome 2025-11-22 anticipated 30 Complete https://irct.ir/trial/87593 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 1. Randomization method and explanation: Main method: Simple Randomization, which will be performed using a random number table. - Reason for choosing this method: No need to control the intervening variables in the study and ease of implementation. - Quasi-random method: Quasi-random methods will not be used in this study. 2. Randomization unit: Individual randomization: Each participant will be randomized independently and without grouping (such as cluster or block). 3. Randomization tool: - Random Number Table: - After assigning unique numbers to the participants( In the base of Randomization method), corresponding numbers are selected from the table. - Even numbers are assigned to the intervention group and odd numbers to the control group. 4. How to create a random sequence: - Step-by-step steps: 1. A complete list of the statistical population (based on the study entry criteria) will be prepared. 2. Each person will be assigned a unique numerical code. 3. By referring to the random number table, numbers corresponding to the codes will be selected and assigned to the group. 5. Allocation Concealment: - Method: Use of sealed envelopes and use of a third party. - Process Description: - After determining the random sequence, the names of the groups (intervention/control) will be placed in opaque envelopes. - The envelopes will be kept and opened by an independent person who will not play a role in the study. - Objective: To prevent selection bias by the researcher. - 6. Stratification: - Stratified randomization will not be used in this study. - 7. Supplementary Notes: - Transparency of the lottery process: - With respect to the traditional method (taking paper from the container), it is worth noting: - The container will be shaken homogeneously. - The papers will be the same in size and shape. - The process will be recorded by an independent observer. It is also worth noting that this method was designed in accordance with CONSORT guidelines for simple randomization and allocation concealment (REF), Blinding description: 1. Overall Blinding Design: - This study will be designed as a single-blind study, meaning that: Participants will not be aware of their group allocation (intervention or control). 2. Implementation methods for blinding participants: a) For the intervention group: - In addition, the intervention will be carried out at the house of the individuals, so the intervention is designed to be similar in appearance to the daily activities of the individuals in this group and its implementation will not interfere with daily activities. - Neutral terms will be used to describe the intervention (instead of "new program", "activity program" will be used). b) For the control group: - Participants will be told that they are participating in a "daily activity pattern study" and will not do heavy exercise during this period. - They will be asked to continue their usual activities without change. - Both groups will be monitored from the same time and under the same conditions. 3. Standardization of conditions for both groups: - Research calls: The number and duration of follow-up calls will be the same for both groups. The content of the conversations is standardized in advance. - Measurement instruments: * The same instruments will be used for both groups. * The instructions for the tests and measurement instruments will be the same. 4. Control of confounding factors: - Time separation: * Assessment sessions for the two groups will be held at different times. * Interaction between members of the two groups will be prevented. - Trained personnel: * Researchers involved in the study are trained to prevent unwanted disclosure of information. 5. Evaluation of blinding success: - At the end of the study, participants will be asked: * "Which group do you think you were in?" * "How sure are you of this?" 6. Documentation and appendices: - Standardized blinding instructions will be attached as an appendix to the study protocol. It is important to note that the above section and the methods mentioned are designed in accordance with Section 11b of the CONSORT 2010 guidelines. Finally: These arrangements will ensure that: 1. Participants will not be able to tell whether they are in the intervention or control group. 2. This lack of awareness of group allocation will prevent participants from biasing their reporting of results. N/A Carpal tunnel syndrome. Intervention 1: Nerve stretching and massage exercise group. Intervention 2: Control group. Yes - There is a plan to make this available What will be shared: The data file without names and personal information, the raw sample of the informed consent form, and the clinical study report are included in the text of the final research report. When: After completing the research project, up to six months thereafter To whom: Everyone Conditions: Any manipulation of data, misuse, or plagiarism of it without citing the source is not permitted. Where to obtain: Fariborz Hovanloo, Contact Number: 29905847 University Address: Shahid Shahryari Square, Evin, Tehran, Email: F_Hovanloo @sbu.ac.ir How to obtain: After applying in person or electronically and in case of verification, a maximum of 1 week Comments:
public Fariborz Howanloo
shahid beheshti university- shahid shahriari Sq- evin
Tehran Iran (Islamic Republic of) 1983969411 86705503 21 0098 F_Hovanloo@sbu.ac.ir shahid beheshti University of Tehran scientific Fariborz howanloo
shahid beheshti university- shahid shahriari Sq- Evin
Tehran Iran (Islamic Republic of) 1983969411 86705503 21 0098 F_Hovanloo@mail.sbu.ac.ir shahid beheshti university of Tehran Iran (Islamic Republic of) Have at least 1 year of experience playing the piano Having moderate pain in the wrist (VAS score 4 to 7) Having mild to moderate symptom severity and functional status Age range 20-40 years Positive at least one of the Fallen and Tinel physical examination tests Absence of predisposing factors such as diabetes, hypothyroidism, hyperthyroidism, acute trauma, pregnancy Not participating in a physical therapy program in the previous month Absence of medical conditions that would contraindicate massage therapy 20 years 60 years Both Unwillingness to continue cooperation Having three absentee sessions in the entire protocol Failure to submit self-massage report Failure to participate in the post-test Rehabilitation Lifestyle Nerve stretching and massage exercise group Control group Wrist pain. Timepoint: Pre-test & post-test. Method of measurement: Visual Analogue Scale. Wrist strength. Timepoint: Pre-test & post-test. Method of measurement: Hand dynamometer. Wrist flexibility. Timepoint: Pre-test & post-test. Method of measurement: Goniometer. shahid beheshti university of Tehran Approved 2025-04-12 research Ethics Committee of Shahid Beheshti University Shahid Shahryari Square, Evin, Tehran Tehran Iran (Islamic Republic of)