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IRCT20130409012953N4 IRCT 2023-08-21 Deputy of Research of Iran University of Medical Sciences Effect of dry needling in treatment of scar The effectiveness of dry needling on scar tissue: a randomized controlled trial 2023-09-23 anticipated 80 Complete https://irct.ir/trial/66082 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible patients with hypertrophic scar tissue will be randomized to an intervention group (dry needling in addition to routine physical therapy) and a control group (sham dry needling in addition to routine physical therapy) with a ratio of 1:1. Randomized allocation will be performed by using permuted block randomization method, which consists of four-letter blocks made of letters A and B. Then, the random treatment list that will be obtained at the end of the random allocation task will be placed in letters A and B inside the sealed and numbered envelopes (A letter indicates true dry needling and letter B indicates sham dry needling). Six four-letter blocks of letters A and B will be created in which the letter A or B is not repeated more than twice in each block. These blocks include AABB, ABAB, BBAA, BAAB, ABBA, BABA. Considering that each block represents 4 participants and in the current study, 80 participants are needed, 20 blocks of four are required. Referring to a table of 20 random numbers between 1 to 6 (the number of blocks created above), the selection process will be performed using Google Random Number Generator. The random assignment process will be performed by someone outside the research team before the study begins. After the initial evaluation of the patient by the examiner, the numbered envelopes will be presented to him/her according to the ordinal number of each person admitted to the study. Finally, after each patient enters the treatment sessions, the therapist will adjust the treatment interventions based on the letters in the envelope. Patients are asked not to provide their grouping information to the assessor to prevent data contamination, Blinding description: Individuals in the control group will be in the same position as those in the intervention group, with needles placed superficially in an area slightly further away from the scar tissue. Additionally, the data analyst will be unaware of the grouping of the participants, and each participant will be identified by a unique numerical code. 3 Scar tissue. Intervention 1: Intervention group: Dry needling therapy in the true dry needling group along with routine physiotherapy is performed by inserting a 2 cm Dung bang brand needle at an angle of about 15 degrees to the skin surface into the scar tissue and rotating it to separate the tissue adhesions. This is done along the path of the scar. The number of treatment sessions for patients is 6 sessions, which will be performed 3 sessions per week for two weeks. The assessment of participants will be done once before starting the treatment, immediately after the end of the treatment, and two weeks after the last treatment session. Routine physiotherapy treatment for patients with scars in both groups includes using kinesiology taping along with infrared (for 20 minutes) at a distance of 30 cm from the scar tissue. Intervention 2: Control group: In the sham dry needling treatment group along with routine physiotherapy, the patient's condition is completely similar to the real dry needling treatment group, except that instead of a real needle, a sham needle is used. The needle is inserted superficially at a point further away from the scar tissue and is removed after 20 minutes. Routine physiotherapy in this group is similar to the main intervention group. Yes - There is a plan to make this available What will be shared: The raw data of research and its analysis will be available to the researcher if they request it. When: After six months from the date of publication. To whom: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of dry needling. Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of dry needling. Where to obtain: Applicants can contact Dr. Mohammad Reza Pourahmadi by email. Email address: pourahmadipt@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Mohammadreza Pourahmadi
Madadkaran (Nezam) St., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences scientific Mohammadreza Pourahmadi
Madadkaran (Nezam) St., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) United States of America Longitudinal scar tissue older than six weeks No contraindication for joint active and passive movements near the scar tissue Age between 20-60 years 20 years 60 years Both Trypanophobia Skin problems (such as infection, wounds, atopic dermatitis) L90.5 Scar conditions and fibrosis of skin Rehabilitation Placebo Intervention group: Dry needling therapy in the true dry needling group along with routine physiotherapy is performed by inserting a 2 cm Dung bang brand needle at an angle of about 15 degrees to the skin surface into the scar tissue and rotating it to separate the tissue adhesions. This is done along the path of the scar. The number of treatment sessions for patients is 6 sessions, which will be performed 3 sessions per week for two weeks. The assessment of participants will be done once before starting the treatment, immediately after the end of the treatment, and two weeks after the last treatment session. Routine physiotherapy treatment for patients with scars in both groups includes using kinesiology taping along with infrared (for 20 minutes) at a distance of 30 cm from the scar tissue. Control group: In the sham dry needling treatment group along with routine physiotherapy, the patient's condition is completely similar to the real dry needling treatment group, except that instead of a real needle, a sham needle is used. The needle is inserted superficially at a point further away from the scar tissue and is removed after 20 minutes. Routine physiotherapy in this group is similar to the main intervention group. The flexibility of the scar tissue. Timepoint: At the start of the study (prior to the intervention), immediately following the final treatment session, and two weeks after the completion of the treatment sessions. Method of measurement: Tissue compliance meter. Active and passive joint range of motion. Timepoint: At the start of the study (prior to the intervention), immediately following the final therapy session, and two weeks after the completion of the treatment sessions. Method of measurement: Universal goniometer. Pain. Timepoint: At the start of the study (prior to the intervention), immediately following the final therapy session, and two weeks after the completion of the treatment sessions. Method of measurement: Numeric pain rating scale. Functional disability. Timepoint: At the start of the study (prior to the intervention), immediately following the final therapy session, and two weeks after the completion of the treatment sessions. Method of measurement: SF-36 questionnaire. Deputy of Research of Iran University of Medical Sciences Approved 2022-08-27 Ethics committee of Iran University of Medical Sciences Madadkaran (Nezam) St., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran. Tehran Tehran Iran (Islamic Republic of)