Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study
Rigshospitalet, Denmark
80 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. The main questions it aims to answer are: * Is the treatment safe and effective? * Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation? Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.
Eligibility
Inclusion Criteria12
- Are 18 years or older
- Are diagnosed with diabetes type I or II
- Score 3 or above on the Doleur Neuropathique 4 interview section
- Suffer from pain of the lower extremities which
- is considered by the participant as their dominant overall dominant pain
- is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days)
- is present in both feet, roughly symmetrically.
- has been present for at least 6 months
- Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
- Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
- Are using an approved, safe contraceptive (for premenopausal women)
- Speak, read, and understand Danish
Exclusion Criteria17
- Have a known allergy or hypersensitivity to BonT-A
- Have been treated with BonT in the last 6 months.
- Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Have a known malignant condition
- Have an ongoing infection in the area of injection
- Are expecting to change their pain medication during the study period
- Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
- Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:
- spinal stenosis
- claudication
- previous trauma or nerve injury
- cancer related pain
- Have a psychiatric condition that affects their completion of the study, as assessed by the investigator.
- Are active abusers of alcohol or illegal substances
- Are using or receiving treatment with cannabis products of any kind
- Are pregnant or planning pregnancy during the study period
- Score more than 12 on the Charlson Comorbidity Index
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Interventions
Perineural injection
Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05623111