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IRCT20100127003217N11 IRCT 2019-02-03 Tabriz University of Medical Sciences The Effect of Local Injection of Botulinum Toxin in Parkinson's Patients Therapeutic effectiveness of local Botulinum toxin injection on hand tremor severity and upper limb function in patients with Parkinson disease_ a randomized clinical trial 2019-02-19 anticipated 35 Complete https://irct.ir/trial/36113 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A box containing 35 concealed envelopes is selected. In the 25 envelopes paper for group A and inside the other 10 envelopes, paper for group B is placed. This box is located in front of the patients and an envelope is chosen by each patient. Thus, the patient is completely unaware of group typing and randomly assigned to group A (case) or group B (control). The patient's name is recorded in the list of 25 patients in the case group or 10 patients in the control group. 4 Parkinson's Disease. Intervention 1: Intervention group: injection of diluted Botulinum toxin in the affected hand muscles in addition to Parkinson's routine oral medicine.According to studies conducted so far, 7 muscles from 14 common muscles have been injected in more than 80% of patients, including Flexor Carpi Radialis (FCR), Flexor Carpi Ulnaris (FCU), Pronator Tres, Pronator Quadratous, Extensor Caripi Radialis Longus (ECRL) and Extensor Carpi Ulnaris (ECU) and Supinator. The injectable dose is selected for each muscle depending on the moderate and standard deviation of previous successful efforts (15 ± 5 units of botulinum toxin). According to available resources and general consensus and prevention of severe weakness, to each specified muscles of the forearm flexor, 20 units of Botulinum toxin are injected and to each prescribed muscles of the forearm extensor should be injected 10 to 15 units of Botulinum toxin. Intervention 2: Control group: 10 people in the control group received only Parkinson’s routine oral medication. 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 Not implemented yet
public Dr. Leila Fallah
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 dr_fallah.leila@yahoo.com Tabriz University of Medical Sciences scientific Dr. Fariba Eslamiyan
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with idiopathic or familial Parkinson's disease (Parkinson's disease or PD); age between 30 to 85 years, one year after definitive diagnosis; patients with PD who have hand tremor (single-sided or bilateral). Patients with PD who are in stages I-III of Hoehn & Yahr staging . Patients with PD who are being treated with routine anti-Parkinson drugs, especially levodopa. Patients with PD who are willing to participate in the study and are satisfied with botulinum toxin injections. 30 years 85 years Both Patients with PD who have had cognitive impairment or psychosis Patients with PD who have had a history of botulinum Toxin injection or any other injection over the past four months Patients with PD who have had a history of surgery (DBS: deep brain stimulation) Patients with secondary Parkinsonism, such as Pharmaceutical Parkinsonism Patients with hand tremor which is resulting from a medical condition, such as antipsychotic drugs Pregnancy and breastfeeding G20 Parkinson's disease Treatment - Drugs Treatment - Drugs Intervention group: injection of diluted Botulinum toxin in the affected hand muscles in addition to Parkinson's routine oral medicine.According to studies conducted so far, 7 muscles from 14 common muscles have been injected in more than 80% of patients, including Flexor Carpi Radialis (FCR), Flexor Carpi Ulnaris (FCU), Pronator Tres, Pronator Quadratous, Extensor Caripi Radialis Longus (ECRL) and Extensor Carpi Ulnaris (ECU) and Supinator. The injectable dose is selected for each muscle depending on the moderate and standard deviation of previous successful efforts (15 ± 5 units of botulinum toxin). According to available resources and general consensus and prevention of severe weakness, to each specified muscles of the forearm flexor, 20 units of Botulinum toxin are injected and to each prescribed muscles of the forearm extensor should be injected 10 to 15 units of Botulinum toxin. Control group: 10 people in the control group received only Parkinson’s routine oral medication Clinical severity of hand tremor. Timepoint: At the beginning of the study and before the intervention, 1.5 months, 4 months after injection. Method of measurement: 2 questionnaires including FTM (Fahn_Tolosa_Marin Temor Rating Scale) and UPDRS (Unified Parkinsone Disease Rating Scale). Functional severity of hand tremor. Timepoint: At the beginning of the study and before the intervention, 1.5 months, 4 months after injection. Method of measurement: ADL questionnaire from Bain and Findley questionnaire, manual dynamometer, 10 euro coin test. Tabriz University of Medical Sciences Approved 2018-11-14 Regional Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for Research, Tabriz University of Medical Sciences, Golghasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)