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IRCT20100211003329N13 IRCT 2025-10-27 Kashan University of Medical Sciences The effect of ear acupressure on endocrine therapy-associated musculoskeletal pain in breast cancer survivors The effect of ear acupressure on endocrine therapy-associated musculoskeletal pain in breast cancer survivors 2025-11-01 anticipated 52 Complete https://irct.ir/trial/86835 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible samples will be listed in order of screening and then randomly assigned to each of the two intervention and sham groups in blocks of 8 and 6. Using the Sealed Envelope Ltd. 2017 software available at www.sealedenvelope.com, 4 blocks of 6 and 4 blocks of 8 were defined, for a total of 8 blocks, and the allocation to groups will be done based on the order specified by the software, Blinding description: The subject/participant is unaware of the nature of the seeds prescribed to her, and the person collecting the data is also unaware of the subject's group. N/A breast cancer. Intervention 1: Intervention group: , the researcher will attach ZHONG YANG brand of Vakaria seeds made in China to the points used to relieve stress and pain (including Shenmen, Sympathetic, Subcortex, Antidepressant, Muscle Relaxation) on both earlobes, and the patient will be instructed to press each point using the thumb and forefinger to the extent that it causes mild discomfort.Pressure will be applied to the points for four weeks, five days a week, three times a day (morning, afternoon, and evening), and each time will last for a total of three minutes . In the sham group, adhesives will be applied to the desired points but without seed, and no pressure will be applied to them.It should be noted that during the 4-week intervention, stickers containing Vaccaria seeds in the intervention group and stickers without seeds in the sham group will be attached by the researcher to both ears simultaneously every week, after cleaning the skin with alcohol cotton.The stickers will be worn on the ears for five days a week, and the patient will be asked to remove the stickers at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the stickers come off during the five-day period so that the researcher can reattach the stickers at an agreed-upon location (clinic, office, sample home, etc.).The subjects will be instructed to refrain from exercising, engaging in strenuous physical activity, and using nutritional supplements (except calcium and vitamin D) and other complementary therapies during the study period. If they take painkillers, they will be asked to record the type, dose, and number of times they take them daily.Also, if they experience any complications such as redness, inflammation, and itching in the earlobe area, they should record and report them. During the intervention, the individual will also be given a weekly diary sheet in which they will record the duration of each pressure point, the occurrence of allergic reactions, the use of painkillers, and the start of new medication.The contents of the daily note sheet are organized using visual symbols in a way that can be understood and completed by all subjects, both literate and illiterate, with simple training.During the intervention period, all participants will be visited at the agreed location each week and new labels will be applied to them, and a daily note sheet will be given to them and another sheet will be given to them for the following week. If in the intervention group the average daily duration of pressure on the testicles during each week of the intervention is less than 6 minutes, that person will be excluded from the study.The labeling will continue for 4 weeks and the samples will be followed up for 4 weeks after the end of the intervention. The Persian version of the Short Pain Questionnaire (sensory and reactive dimensions) will be completed at the beginning of the study, weekly until the end of the intervention, and 4 weeks after the end of the intervention for both groups through an interview with the individual by a collaborator who is not aware of the status of the samples' allocation to the groups.At the time of sampling, the telephone number and home address of the subjects were recorded, and during the intervention period, weekly coordination was made over the telephone regarding the time and place of the visit and, if necessary, transportation arrangements, as well as for the purpose of conducting follow-up 4 weeks after the end of the intervention. Intervention 2: Control group: In the sham group, the patches will be applied to the desired areas but without seed, and no pressure will be applied to them. It should be noted that during the 4-week intervention, the patches without seed in the sham group will be applied simultaneously to both ears every week by the researcher, after cleaning the skin with alcohol cotton.The stickers will be placed on the ears five days a week and the patient will be asked to remove the stickers at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the stickers come off during the five-day period so that the researcher can reattach the stickers at an agreed location (clinic, office, sample home, etc.). No - There is not a plan to make this available Justification or reason for not sharing IPD is Not done yet.
public Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Qutb Rawandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5510 3119 tagharrobi_z@yahoo.com Kashan University of Medical Sciences scientific Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
kashan Iran (Islamic Republic of) 8715985191 +98 31 5510 3119 tagharrobi_z@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of stage 1 to 3 hormone-dependent breast cancer (histology report), without recurrence and metastasis to distant sites Taking tamoxifen or aromatase inhibitor drugs for at least 3 months The type of medication must be stable for at least 2 months before the start of the study. Development or worsening of musculoskeletal pain following initiation of endocrine therapy Experiencing musculoskeletal pain for at least 2 months and at least 15 days per month Having pain with an intensity of at least 3 on a scale of 0 to 10 (sensory dimension of the Persian version of the Short Pain Questionnaire) in the week before the start of the study Iranian nationality, resident of Kashan and its suburbs Postmenopausal (age 60 years or older, history of oophorectomy, history of hysterectomy, or amenorrhea for at least 12 months) At least 4 weeks have passed since the completion of surgical, chemotherapy, and radiotherapy treatments. Organ health in the earlobe area 18 years 70 years Female Any type of surgery, musculoskeletal disease, orthopedic or neurological problems during the study Performing any type of intense physical activity or starting a sports activity during the study Use of corticosteroids or opioids during the study Allergy to glue Hospitalization due to physical or mental problems during the study Performing physiotherapy during the study Taking nutritional supplements during the study (except calcium and vitamin D) Changes in endocrine treatment plan during the study Combined use of other complementary therapies Withdrawal from further cooperation during the study Failure to meet the criteria regarding the average daily pressure applied to the heads during each week of intervention (less than 6 minutes per day) Experiencing serious stress, lack of access, death engaging in professional sports activities having fibromyalgia, arthritis and inflammatory arthritis requiring medication, active cancer, rheumatoid arthritis, peripheral nerve problems in the limbs, cognitive impairment, and lymphedema based on patient records and self-report. use of narcotics and corticosteroids using acupuncture in the past 6 months amputation, fracture, or bone surgery within the past 6 months C50-C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: , the researcher will attach ZHONG YANG brand of Vakaria seeds made in China to the points used to relieve stress and pain (including Shenmen, Sympathetic, Subcortex, Antidepressant, Muscle Relaxation) on both earlobes, and the patient will be instructed to press each point using the thumb and forefinger to the extent that it causes mild discomfort.Pressure will be applied to the points for four weeks, five days a week, three times a day (morning, afternoon, and evening), and each time will last for a total of three minutes . In the sham group, adhesives will be applied to the desired points but without seed, and no pressure will be applied to them.It should be noted that during the 4-week intervention, stickers containing Vaccaria seeds in the intervention group and stickers without seeds in the sham group will be attached by the researcher to both ears simultaneously every week, after cleaning the skin with alcohol cotton.The stickers will be worn on the ears for five days a week, and the patient will be asked to remove the stickers at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the stickers come off during the five-day period so that the researcher can reattach the stickers at an agreed-upon location (clinic, office, sample home, etc.).The subjects will be instructed to refrain from exercising, engaging in strenuous physical activity, and using nutritional supplements (except calcium and vitamin D) and other complementary therapies during the study period. If they take painkillers, they will be asked to record the type, dose, and number of times they take them daily.Also, if they experience any complications such as redness, inflammation, and itching in the earlobe area, they should record and report them. During the intervention, the individual will also be given a weekly diary sheet in which they will record the duration of each pressure point, the occurrence of allergic reactions, the use of painkillers, and the start of new medication.The contents of the daily note sheet are organized using visual symbols in a way that can be understood and completed by all subjects, both literate and illiterate, with simple training.During the intervention period, all participants will be visited at the agreed location each week and new labels will be applied to them, and a daily note sheet will be given to them and another sheet will be given to them for the following week. If in the intervention group the average daily duration of pressure on the testicles during each week of the intervention is less than 6 minutes, that person will be excluded from the study.The labeling will continue for 4 weeks and the samples will be followed up for 4 weeks after the end of the intervention. The Persian version of the Short Pain Questionnaire (sensory and reactive dimensions) will be completed at the beginning of the study, weekly until the end of the intervention, and 4 weeks after the end of the intervention for both groups through an interview with the individual by a collaborator who is not aware of the status of the samples' allocation to the groups.At the time of sampling, the telephone number and home address of the subjects were recorded, and during the intervention period, weekly coordination was made over the telephone regarding the time and place of the visit and, if necessary, transportation arrangements, as well as for the purpose of conducting follow-up 4 weeks after the end of the intervention. Control group: In the sham group, the patches will be applied to the desired areas but without seed, and no pressure will be applied to them. It should be noted that during the 4-week intervention, the patches without seed in the sham group will be applied simultaneously to both ears every week by the researcher, after cleaning the skin with alcohol cotton.The stickers will be placed on the ears five days a week and the patient will be asked to remove the stickers at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the stickers come off during the five-day period so that the researcher can reattach the stickers at an agreed location (clinic, office, sample home, etc.). Musculoskeletal pain score. Timepoint: At the beginning of the study, after the end of the intervention, and 4 weeks after the end of the intervention. Method of measurement: Persian version of the Brief Pain Questionnaire. Pain interference score. Timepoint: weekely. Method of measurement: Report of patient. Kashan University of Medical Sciences Approved 2025-10-15 Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medic Kashan University of Medical Sciences, Pezeshk Blvd, Qutb Rawandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)