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IRCT20210216050381N1 IRCT 2022-09-03 Shahid Beheshti University of Medical Sciences Effect of Adding Cupping Therapy to Electroacupuncture in Patients with Knee Osteoarthritis Evaluation Outcome of Adding Cupping-therapy to Electro-acupuncture in Accompany with Exercises on Knee Pain, Function and Life Quality at Osteoarthritis 2022-04-21 anticipated 56 Complete https://irct.ir/trial/54435 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the sample size and number of groups, we write on 28 papers of the control group and 28 papers of the intervention group. We fold the papers so that their writing cannot be read. Then we throw them in the lottery container. The secretary of the clinic, who is not one of the researchers of the project, picks the paper in turn without replacement and is registered in front of the numbers 1 to 56 of the control group and the randomization list is prepared in this way. The next step is to hide the random list. To do this, use opaque sealed envelopes with a random sequence. A number of Sequentially numbered, sealed, opaque envelopes with aluminium wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random numbers is recorded on a card and the cards are placed inside the envelope. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lid of the letter envelopes is glued and placed in a box, respectively. The box is given to the person in charge of reception. Each patient enters the clinic to begin their treatment, take one envelope in order. 3 Condition 1: knee osteoarthritis. Condition 2: Osteoarthritis of knee. Intervention 1: Intervention group: In addition to electroacupuncture and exercise therapy, the intervention group receives a cuping.Cupping therapy, patients are treated with a glass cup at the location of the genicular nerves around the knee. Acuzone branding is made in Korea. The cup is placed on the skin and suction is created with its rifle series. It stays on the skin for 5 minutes and then separates from the skin. It is done twice a week for four weeks. In total, eight sessions are done. Intervention 2: The control group receives electroacupuncture and an exercise therapy program. Patients are given exercises. Exercises include isometric quadriceps. While lying on back, keep both knees bent and place a pillow or towel between their knees. Gently apply pressure to the pillow. Hold for five seconds and release. patients do the exercises three sets of five repetitions daily. The intensity of the pressure is to the threshold of pain.Patients also receive electroacupuncture. To do electropuncture: The patient lies on his back on the bed. The site is completely disinfected with an alcohol pad. Electroacupuncture is performed as for 20 minutes (two per week) for a total of 8 sessions. Disposable needles, sterile, 25.25 0. 0.25 mm (disposable needle of Huang Xiu Medical Company, China) will be used in two groups. Electroacupuncture is performed bilaterally and in cases where only one patient has a sore knee, it is performed unilaterally. Acupuncture points are selected according to Chinese acupuncture points. If the patient has a clear trigger point around the knee, a needle should be inserted in this area as well. The needles should not enter the joint space. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after disabling individuals. When: Access period starts six months after the article is published To whom: Researchers working in academic and scientific institutions Conditions: Written request for access to data is possible. Where to obtain: For requesting Documents or data correspond to this address: Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran How to obtain: The applicant requests data or study details and provides the contact address. The data is then made available. Comments:
public Maryam saddat Ganjalikhani
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1505 Maryam.ganjalikhani@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam saddat Ganjalikhani
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1505 Maryam.ganjalikhani@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Men and women over 40 and under 75 years old Body mass index between 18-35 Knee pain for 6 months or more (chronic pain and acutely pain aggravation) Normal neurologic examination Radiology symptoms of osteoarthritis in the knee and at least one osteophyte (grade 2 and 3 criteria of klegran Lawrence) in the tibiofemoral joint of the knee 45 years 70 years Both Knee pain due to problems other than osteoarthritis (rheumatoid arthritis, other rheumatic diseases, etc.) Knee or pelvic replacement surgery in the joint involved or any surgical procedures in the lower extremities during the last 6 months Intra-articular injections of corticosteroids in 6 months, gel and PRP in the last year, the onset of oral opioid or corticosteroid painkillers during the last 4 weeks Physical disorder that prevents a person from doing exercises. Wounds or any lesions caused in knee during treatment sessions (for any reason) taking painkiller other than acetaminophen more than three times at any dose M17.0 M17 Bilateral primary osteoarthritis of knee Osteoarthritis of knee Treatment - Devices Treatment - Other Intervention group: In addition to electroacupuncture and exercise therapy, the intervention group receives a cuping.Cupping therapy, patients are treated with a glass cup at the location of the genicular nerves around the knee. Acuzone branding is made in Korea. The cup is placed on the skin and suction is created with its rifle series. It stays on the skin for 5 minutes and then separates from the skin. It is done twice a week for four weeks. In total, eight sessions are done. The control group receives electroacupuncture and an exercise therapy program. Patients are given exercises. Exercises include isometric quadriceps. While lying on back, keep both knees bent and place a pillow or towel between their knees. Gently apply pressure to the pillow. Hold for five seconds and release. patients do the exercises three sets of five repetitions daily. The intensity of the pressure is to the threshold of pain.Patients also receive electroacupuncture. To do electropuncture: The patient lies on his back on the bed. The site is completely disinfected with an alcohol pad. Electroacupuncture is performed as for 20 minutes (two per week) for a total of 8 sessions. Disposable needles, sterile, 25.25 0. 0.25 mm (disposable needle of Huang Xiu Medical Company, China) will be used in two groups. Electroacupuncture is performed bilaterally and in cases where only one patient has a sore knee, it is performed unilaterally. Acupuncture points are selected according to Chinese acupuncture points. If the patient has a clear trigger point around the knee, a needle should be inserted in this area as well. The needles should not enter the joint space. Knee pain. Timepoint: Before intervention and at the end of intervention after eight weeks. Method of measurement: Womac questionnaire, VAS form. Quality of life. Timepoint: Before intervention and at the end of intervention at the eight week. Method of measurement: Vas form,WOMAC questionnaire. Knee stiffness. Timepoint: Before intervention and at the end of intervention at the eight week. Method of measurement: WOMAC questionnaire, VAS form. Shahid Beheshti University of Medical Sciences Approved 2021-02-14 Ethics committee of shahid Beheshti university of medical sciences Exercise and sport medicine department, (Ayatollah) Taleghani Educational Hospital ,erabi avenue, velenjak Tehran Tehran Iran (Islamic Republic of)