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Title : A study of efficacy and safety of Botulinum toxin type A for the treatment of Chronic Post-Surgical Neuropathic Pain. A single-arm, before-and-after, open-label Clinical Trial

Title : A study of efficacy and safety of Botulinum toxin type A for the treatment of Chronic Post-Surgical Neuropathic Pain. A single-arm, before-and-after, open-label Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141023019640N5
Enrollment
15
Registered
2024-09-05
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Treatment of chronic neuropathic pain after surgery. Other chronic postprocedural pain

Interventions

Intervention group: Injection of botulinum toxin type A (Masport) (BoNT/A) in an amount of 500 U in 5 or 10 ml of saline (5 or 10 IU/0.1 ml) will be administered subcutaneously based on the extent of

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: male or female over 19 years old Suffering from neuropathic pain based on the DN4 questionnaire (Douler Neuropathique 4) dermatological pattern of pain after surgery characteristics of neuropathic pain including numbness, tingling, tingling, electric shock, burning, hyperalgesia, allodynia (pain with a stimulus that It usually does not cause pain (falling asleep and itching)

Exclusion criteria

Exclusion criteria: contraindications for BoNT (eg, myasthenia gravis or other neuromuscular junction diseases) hypersensitivity to the BoNT coagulation disorders other painful conditions History of previous BoNT treatment Concomitant use of pain medication is allowed, provided that the dose has been stable for at least 1 month before enrollment and will remain stable during the study. opioid usage

Design outcomes

Primary

MeasureTime frame
Primary outcome measures will include changes in pain intensity. Timepoint: pain intensity in the last 24 hours using NRS (0=no pain, 100=unbearable pain) at 2, 4, 8 and 12 weeks after injection. Method of measurement: numeric rating scale (NRS).

Secondary

MeasureTime frame
Secondary outcome measures will include changes in quality of life. Timepoint: quality of life at 2, 4, 8, and 12 weeks after injection using the SF36 questionnaire. Method of measurement: SF-36 questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Majedi Ardakani

Tehran University of Medical Sciences

hmajedi@tums.ac.ir+98 21 6119 2490

Outcome results

None listed

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