2023-507259-31-00CompletedPhase 4
The effect of perineural botox on chronic cutaneous neuropathic pain
Aarhus Universitetshospital1 site in 1 country50 target enrollmentStarted: October 16, 2023Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The number of responders in the botox group versus the placebo group. Responders are defined as patients who at the 4 weeks follow-up, describe the pain-relieving effect in the neuropathic area(s) during the last 48 hours as mild, moderate or good.
Study Overview
Brief Summary
The main objective is to investigate the pain-relieving effect of perineural botox injection in patients with chronic cutaneous neuropathic pain
Study Design
- Allocation
- Randomized
- Primary Purpose
- The effect of perineural botox on chronic cutaneous neuropathic pain
- Masking
- Double (Carer, Investigator, Subject, Analyst, Monitor)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •In one or more painful and neuro-anatomically relevant area is at least one of the following criteria present when compared to the contralateral side: (1) Hypoesthesia/anesthesia for touch (brush); Hypoesthesia/anesthesia for moderate cold (alcohol swab); (3) Hypoesthesia/anesthesia for moderate heat (thermo roller); (4) Hypoesthesia/anesthesia for pinprick (Neuropen); (5) Allodynia for touch (brush); (6) Allodynia for moderate cold (alcohol swab); (7) Allpdynia for moderate heat (Thermo roller); (8) Hyperalgesia for pinprick (Neuropen)
- •Diagnostic ultrasound guided nerve block performed at the Nerve Injury Clinic at Aarhus University Hospital within the last 28 days before inclusion, where injection of local anesthetic around the neuropathic nerve(s) resulted in a pain reduction to NRS score 3 or below at the same provocation which previously resulted in maximal pain
- •American Society of Anesthesiologists physical status classification score (ASA) I-III
- •Suitable candidate for injection of botox (sponsor-investigator's assessment)
- •Informed consent
- •Able to subjective evaluation of pain
- •Able to read and understand Danish and to read, understand and sign the informed consent form
- •Worst pain in rest/activity/at provocation NRS (Numeric rating scale) score ≥ 5 in the primary area(s) of pain for at least 6 months at the time of inclusion
- •Has tried relevant medical first line treatment for the neuropathic pain where the treatment is currently stable or terminated
- •The localization of the painful skin area is neuro-anatomically plausible in relation to the suspected nerve damage (sponsor-investigator's assessment)
Exclusion Criteria
- •Know allergy towards Botulinum A or any substances listed in "Produktresumé for ”BOTOX, pulver til injektionsvæske, opløsning 50, 100 og 200 Allergan-enheder”
- •Breast feeding or pregnancy. All women without verified menopause will be tested for pregnancy (urine HCG) on the day of inclusion. Verified menopause is defined as > 1 year since the last period without any other explanation and age >45 years
- •Abuse of alcohol or drugs (illegal and prescription drugs) assessed by sponsor-investigator
- •Participation in other clinical studies which may interfere with the present (sponsor-investigator's assessment)
- •Any ongoing patient case/complaint related to the present cutaneous neuropathic pain
- •Not able to cooperate
- •Infection in the area around the site of injection
- •Significant competing pain which could interfere with the estimation of the treatment effect (sponsor-investigator's assessment)
- •Current diagnosis of progressive neurological disease
- •Uncontrolled, severe systemic disease
- •Previous interventional pain treatment (e.g., spinal cord stimulation, cryoneurolysis, botox) without relevant effect for the same persisting, cutaneous neuropathic pain (note that Transcutaneous Electrical Nerve Stimulation, TENS, is not considered interventional)
- •Previous injection of botox for the same persisting, cutaneous neuropathic pain
- •Number of nerves where the diagnostic nerve block provides pain relief is greater than 3
Outcomes
Primary Outcomes
The number of responders in the botox group versus the placebo group. Responders are defined as patients who at the 4 weeks follow-up, describe the pain-relieving effect in the neuropathic area(s) during the last 48 hours as mild, moderate or good.
The number of responders in the botox group versus the placebo group. Responders are defined as patients who at the 4 weeks follow-up, describe the pain-relieving effect in the neuropathic area(s) during the last 48 hours as mild, moderate or good.
Secondary Outcomes
- Change in overall pain score (NRS) estimated during the last 48 hours at the time of the 4-week follow-up in botox versus placebo group
- Change in pain score (NRS) at rest/activity/provocation in the neuropathic area(s) estimated during the last 48 hours at the time of the 4-week follow-up in botox versus placebo group
- Time to onset of the pain-relieving effect of botox, where effect is defined as mild, moderate or good pain-relieving effect for at least 48 hours
- Time to onset of maximal pain-relieving effect of botox
- Change in overall maximal pain score (NRS) for botox responders
- Number of patients in the botox group with maximal pain-relieving effect later than at the 4-week follow-up
- Overall satisfaction (not satisfied/satisfied) with the treatment in the botox versus placebo group evaluated at the 4- week follow-up
- Change in sleep quality (worse, unchanged, improved) in the botox versus placebo group evaluated at the 4-week follow-up
- Change in activity level (lower, unchanged, higher) in the botox versus placebo group evaluated at the 4-week follow-up
- "Patient global impression of change" in botox versus placebo groups evaluated at the time of 4-week-follow-up
- Duration of pain relieving effect (number of days) after injection of botox estimated in botox responders.
- Number of patients in the botox group who would recommend the treatment to other patients
- Number of patients in the botox group who would want to receive botox treatment again in the future
- Adverse events estimated from the time og injection of trial medication until the end of the trial
Investigators
Thomas Fichtner Bendtsen
Scientific
Aarhus Universitetshospital
Study Sites (1)
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