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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100127003217N11
Enrollment
35
Registered
2019-02-03
Start date
2019-02-19
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease. Parkinson's disease

Interventions

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

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Leila Fallah

Tabriz University of Medical Sciences

dr_fallah.leila@yahoo.com+98 41 3337 3967

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026