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IRCT20200720048152N1 IRCT 2023-02-01 Kerman University of Medical Sciences The effect of Cupping on lumbar pain of the elderly CT The effect of Cupping on nonspecific lumbar pain of the elderly referred to the Iranian Medicine Clinic. 2022-12-13 anticipated 70 Complete https://irct.ir/trial/67767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization is done in a simple way using a table of random numbers. The collaborator of the Project, who does not intervene in the research process, first prepares pockets according to sample size and numbers them, then based on the table of random numbers, randomly select a number and read the entire column bellow it vertically. The numbers whose right two digits are between 01 to 70 up to 35 numbers are placed in cupping therapy group and the rest are assigned to the placebo group. The type of treatment is written in each envelope and envelopes are closed and sealed. A four-digit code is written on each envelope. Two digits on the left correspond to the order of patient’s entry into the study and completes the informed consent form, are added to the first digits. an envelope is opened and the assigned group and day of visit is specified for that patient, Blinding description: In order to blind the study, The collaborator of the project, who was not involved in the treatment process or the data analysis process, puts the patients into two groups by a simple random method and using a sealed envelope. The first group is treated with dried cupping, and the second group is treated with placebo (cupping glasses are placed on the skin with a slight negative pressure and use of glue). N/A low back pain. Intervention 1: Intervention group: After random allocation of patients in to two groups of cupping therapy and placebo, in cupping therapy group, 4-10 acrylic cups with a diameter of 25-50 mm were used, the air inside them was heated by the flame of alcohol cotton and the cups were placed on paravertebral region at a distance between l1 and l5 in parallel, for 7-10 minutes. As the air inside the cup cools down and creates suction, the skin is drawn into the cup due to the created vacuum. In such a way that the skin turns from bright red to dark pink. The duration of treatment is 10 days, into every other day in even or odds day to avoid patients of two groups confronting each other. Generally, each person is subjected to 5 sessions. If analgesics are needed, matching is done in both groups. Intervention 2: Control group: In the placebo group, by a manual cupping machine with a single suction and double adhesive support, 4-10 acrylic cups with a diameter of 25-50 mm, are attached only to the suction position on both sides of the vertebral column and in parallel at a distance between l1 and l5 (without changing the color of the skin). The cups are removed after 7-10 minutes. The duration of treatment is 10 days, into every other day in even or odds day to avoid patients of two groups confronting each other. Generally, each person is subjected to 5 sessions. If analgesics are needed, matching is done in both groups. 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 privacy of patient information
public Ali Sarhadinejad
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 A.sarhadi74@yahoo.com Kerman University of Medical Sciences scientific Esmat Nouhi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 091319888576 smnouhi@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Willingness and satisfaction of the patient to participate in the study The presence of non-specific musculoskeletal pain in the lower back based on the doctors diagnosis Age>60 years (35) Mild to moderate pain intensity 4-8 on VAS Low back pain>=3 month (8) BMI <35 (34) 60 years no limit Both Back pain caused by trauma inflammatory or malignant disease Presence of coagulopathy disease or anticoagulant agent consumption Existence of radiculopathy symptoms such as radiating pain, paresis, prickling, or tingling of lower limb Serious acute or chronic organic disease such as diabetes , mental disorders Congenital malformation of the spine Treatment with physiotherapy or opiates and other procedures within the last 4 weeks Central Nervous System impairment M54.5 کمردرد Treatment - Devices Treatment - Devices Intervention group: After random allocation of patients in to two groups of cupping therapy and placebo, in cupping therapy group, 4-10 acrylic cups with a diameter of 25-50 mm were used, the air inside them was heated by the flame of alcohol cotton and the cups were placed on paravertebral region at a distance between l1 and l5 in parallel, for 7-10 minutes. As the air inside the cup cools down and creates suction, the skin is drawn into the cup due to the created vacuum. In such a way that the skin turns from bright red to dark pink. The duration of treatment is 10 days, into every other day in even or odds day to avoid patients of two groups confronting each other. Generally, each person is subjected to 5 sessions. If analgesics are needed, matching is done in both groups. Control group: In the placebo group, by a manual cupping machine with a single suction and double adhesive support, 4-10 acrylic cups with a diameter of 25-50 mm, are attached only to the suction position on both sides of the vertebral column and in parallel at a distance between l1 and l5 (without changing the color of the skin). The cups are removed after 7-10 minutes. The duration of treatment is 10 days, into every other day in even or odds day to avoid patients of two groups confronting each other. Generally, each person is subjected to 5 sessions. If analgesics are needed, matching is done in both groups. Low back pain intensity. Timepoint: registration of daily pain intensity from day 0-10. Method of measurement: Visual Analog Scale questionnaire: VAS (0-10). with out grant Approved 2022-12-12 Research Ethics Committees of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)