IRCT20240811062721N1 IRCT 2025-02-07 Shahid Beheshti University of Medical Sciences Evaluation the effects of a Massage device on muscle spasm in neck and shoulder Evaluation the effects of Massage Gun on pain and range of mation in the upper Trapezius myofascial trigger point, a randomized clinical Trial 2024-08-21 anticipated 40 Complete https://irct.ir/trial/78620 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In order to achieve bias and comparability between the two groups, a generation method is used to assign individuals to the case and control groups. The method used in this study is the generation of random numbers. In this way, a number is generated randomly for each participant in the study. After generating random numbers with the help of statistical software, a threshold value, for example 0.5, is determined to determine whether the individual is assigned to the control or the case group. For example, if the random number assigned to the individual is less than 0.5. In order to assign individuals to groups, the participants are distributed to the control groups and examined to have an identification process of the participants in each group. If the absence between the two groups is severe, the participants are re-randomized. SPSS software is used to generate random numbers. To conduct random assignment and assign participants to intervention and control groups in this study, the following steps were taken using SPSS: 1. **Creating New Variables**: A new variable named "Group" was created in the SPSS data file to determine the intervention and control groups. 2. **Generating Random Numbers**: The `RV.UNIFORM(0,1)` function was used to generate random numbers between 0 and 1 for each participant. This function can be executed in SPSS by going to the `Transform` menu and selecting `Compute Variable`. 3. **Defining the Threshold**: A threshold value of 0.5 was set. The random numbers generated for each participant were compared to this threshold. 4. **Assigning Groups**: If the random number generated for a participant was less than 0.5, they were assigned to the intervention group (e.g., value of 1); otherwise, they were assigned to the control group (e.g., value of 0). This assignment was implemented using the following SPSS command: ```plaintext IF (RV.UNIFORM(0,1) < 0.5) Group = 1. ELSE Group = 0. EXECUTE. ``` 5. **Checking Randomization Distribution**: After randomization, the distribution of participants in the intervention and control groups was checked to ensure the randomization process had resulted in a balanced representation of participants in each group, Blinding description: The assessment before and after the treatment is done by a sports medicine resident who is not involved in the treatment, and the information collection form, does not include written information on the treatment method. The analysis is done by Amarist and the information of the two groups is delivered to Amarist with a code for evaluation. N/A muscle spasm. Intervention 1: Intervention group: Three treatment sessions with a Urikar massage gun by the therapist and each session lasts for 5 minutes at a low speed (level 1 equivalent to 30-40 Hz) in the location of muscle trigger points in the upper trapezius muscle. Intervention 2: Three sessions of acupuncture treatment for 10 minutes each session using 3 to 10 25 x 25 Huanqiu needles in the location of muscle trigger points in the upper trapezius muscle. 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 no more information