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IRCT20111025007903N13 IRCT 2023-05-11 Tehran University of Medical Sciences Effect of Ozone injection on knee osteoarthritis Effect of intra-articular Ozone injection on pain and function in patients with mild to moderate knee osteoarthritis 2020-01-15 anticipated 60 Complete https://irct.ir/trial/63087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were entered into the study using randomized block tables. We prepared 10 blocks, and six patients were considered for each block. Patient one entered block 1, patient two/block 2, patient 3/block 3… patient 10/ block 10. Then the rotation repeated again, patient 11/block 1…until patient 60/block 10, respectively. After that, the third person who he did not aware of the patients’ groups, selected 5 blocks as the control group and 5 blocks as the injection group, according to a random sequence. This method not only caused randomization to be equal in both groups but also at each stage of the study, patients were equally assigned to the groups. These small blocks kept the balance between the two groups and made the number of people in each group the same, Blinding description: Patients were blinded with a shield on the knee The investigator and the outcome assessor were blinded about the type of injection. 3 Osteoarthritis. Intervention 1: Intervention group: For knee injection, a 22-gauge syringe was used by the classic anterolateral approach in a supine position and at an angle of 90 degrees to the knee. In the intervention group, 10 ml of 20 μg of ozone solution was used intra-articular. A total of six intra-articular injections of ozone were given to each patient for six consecutive weeks (one injection per week). After the injection, an ice pack was used at the injection site to prevent hematoma. The patients were advised to rest for up to 48 hours and continue the exercise programs afterwards. Participants were received stretching and strengthening exercise during the trial.Exercise program in the form of isometric multi-joint exercises of the muscles around the knee was defined, including the quadriceps, abductors and adductors of the thigh, holding for 10 seconds, ten repetitions three times a day. In addition, stretching exercises include stretching the hamstrings, gastrocnemius and soleus muscles, holding for 20 seconds in a state of painless stretching with a feeling of discomfort caused by stretching, which was done 1 set of 5 repetitions a day. After one month, concentric exercises of the thigh muscles (quadriceps, then abductors and adductors) with one set of 10 repetitions were started, then the number of repeats was increased to 12 repetitions. In the next step, the number of sets was increased to 3 sets per day, and finally, the weight was added by controlling patients' pain and symptoms. The mentioned program was monitored and re-educated by a sports medicine specialist in each injection session. Intervention 2: Control group: In the control group, an insulin syringe was used at the injection point without any injection, only for the feeling of the needle by patients. In addition, the patients were blinded during the injection. A total of six needling with an insulin syringe were given to each patient for six consecutive weeks (one injection per week). The exercise program was similar to the intervention group. 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 There is no further information
public Zahra Alizade
Sports Medicine Research Center, No7, Opposite of Shariati Hospital, Ale-Ahmad Highway
Teanhr Iran (Islamic Republic of) 1411734143 +98 21 6119 2282 z_alizadeh@tums.ac.ir Tehran University of Medical Sciences scientific Zahra Alizadeh
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran
Tehran Iran (Islamic Republic of) 14395578 +98 21886302278 z_alizadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Mild to moderate knee osteoarthritis Body mass index less than 30 Pain exacerbation with walking Age between 45 and 75 years 45 years 75 years Both History of knee trauma or surgery, metabolic or autoimmune diseases Knee effusion Pregnancy or lactation Usage of anti-coagulant drugs M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: For knee injection, a 22-gauge syringe was used by the classic anterolateral approach in a supine position and at an angle of 90 degrees to the knee. In the intervention group, 10 ml of 20 μg of ozone solution was used intra-articular. A total of six intra-articular injections of ozone were given to each patient for six consecutive weeks (one injection per week). After the injection, an ice pack was used at the injection site to prevent hematoma. The patients were advised to rest for up to 48 hours and continue the exercise programs afterwards. Participants were received stretching and strengthening exercise during the trial.Exercise program in the form of isometric multi-joint exercises of the muscles around the knee was defined, including the quadriceps, abductors and adductors of the thigh, holding for 10 seconds, ten repetitions three times a day. In addition, stretching exercises include stretching the hamstrings, gastrocnemius and soleus muscles, holding for 20 seconds in a state of painless stretching with a feeling of discomfort caused by stretching, which was done 1 set of 5 repetitions a day. After one month, concentric exercises of the thigh muscles (quadriceps, then abductors and adductors) with one set of 10 repetitions were started, then the number of repeats was increased to 12 repetitions. In the next step, the number of sets was increased to 3 sets per day, and finally, the weight was added by controlling patients' pain and symptoms. The mentioned program was monitored and re-educated by a sports medicine specialist in each injection session. Control group: In the control group, an insulin syringe was used at the injection point without any injection, only for the feeling of the needle by patients. In addition, the patients were blinded during the injection. A total of six needling with an insulin syringe were given to each patient for six consecutive weeks (one injection per week). The exercise program was similar to the intervention group. Knee pain. Timepoint: before intervention, 6 weeks and, 6 months after injection. Method of measurement: Visual Analogue Scale. Function. Timepoint: before intervention, 6 weeks and, 6 months after injection. Method of measurement: 6minute walking test. Tehran University of Medical Sciences Approved 2019-12-28 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Dr. Gharib street, Tohid square TEHRAN Tehran Iran (Islamic Republic of)