Clinical trial NCT06036043: Botulinum Toxin for Chronic Neuropathic Pain
Official title: Botulinum Toxin for Chronic Neuropathic Pain - an Interventional Open Label Study at the Interdisciplinary Pain Center, Zealand University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuralgia
Chronic Pain
Keywords: Botulinum Toxin
chronic pain
neuropathic pain
Lead sponsor: Region Zealand
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic neuropathic pain

Brief summary: Treatment of peripheral neuropathic pain with Botulinum Toxin (BoNT) has showed promising results since the first study was released in 2001. Further research, however, is needed in order to strengthen the treatment, and a number of questions are unanswered. This includes which indication is the treatment the most effective, how should the treatment be administered, what is the duration of the effect? This study is a prospective interventional open label study, designed to assess the efficacy and safety of Botolinum toxin in the treatment of chronic neuropathic pain.

Detailed description: Background:

There are eight randomized controlled trials investigating the effectiveness of BoNT for peripheral neuropathic pain. The indications in the studies include diabetic neuropathy, post-herpetic neuropathy, and peripheral nerve injury. Overall, the studies indicate a treatment effect that is significantly better than placebo. However, the studies are relatively small, their outcome measures vary, making comparison difficult, and there is considerable variation in the degree of pain reduction. The duration of the effect of BoNT treatment varies greatly and has not been systematically studied. The current evidence provides a promising background in the treatment of BoNT og neuropathic pain, but further research and documentation are needed.

At the Interdisciplinary Pain Center, Zealand University Hospital, BoNT treatment is already used for patients with neuropathic pain, who do not respond to 1. and 2. line treatments. This study will evaluate the efficacy of the treatment.

Method:

The objective of this study is to prospectively follow a one-year cohort and subsequently conduct a follow-up of 7 months (three treatments) for patients initiating BoNT treatment. The follow-up includes monitoring the treatment's effectiveness, duration, and recording adverse reactions.

Eligibility criteria: Inclusion Criteria:

* Condition of neuropathic pain verified by paraclinical examination or supported by underlying diseases (e.g., diabetes or herpes zoster).
* The condition is characterized by allodynia, hyperalgesia, and/or neuralgiform symptoms such as burning and stabbing pain.
* The affected area can be identified through objective examination with detection of disturbances in touch using cotton swabs, pin-prick, and/or vibration

Exclusion Criteria:

* Mixed etiology of pain not solely attributable to neuropathy (e.g., fibromyalgia and neuropathy or nociceptive pain and neuropathy).
* Contraindication to BoNT treatment (allergy to the toxin).
* Pregnancy.
* Diseases where BoNT treatment is contraindicated, such as motor neuron diseases and muscular dystrophy.
* Severe psychiatric disorder.

Primary outcomes:
measure: Maximal pain intensity
timeFrame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
measure: pain intensity at rest
timeFrame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®)
measure: Frequency of serious adverse events
timeFrame: Up to 7 months after initiating treatment
measure: Frequency of serious adverse reactions
timeFrame: Up to 7 months after initiating treatment
Secondary outcomes:
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
measure: Onset and duration
timeFrame: At 28 days
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: University Hospital of regions Zealand
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas Peter Enggaard, MD, PHD
role: STUDY_DIRECTOR
affiliation: University Hospital of Region Zealand
name: Ole Mathiesen, MD, PHD
role: STUDY_DIRECTOR
References:
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citation: Lippi L, de Sire A, Folli A, D'Abrosca F, Grana E, Baricich A, Carda S, Invernizzi M. Multidimensional Effectiveness of Botulinum Toxin in Neuropathic Pain: A Systematic Review of Randomized Clinical Trials. Toxins (Basel). 2022 Apr 27;14(5):308. doi: 10.3390/toxins14050308.
citation: Attal N, de Andrade DC, Adam F, Ranoux D, Teixeira MJ, Galhardoni R, Raicher I, Uceyler N, Sommer C, Bouhassira D. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2016 May;15(6):555-65. doi: 10.1016/S1474-4422(16)00017-X. Epub 2016 Mar 2.