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Botox as a treatment for chronic nerve pain
EU CTIS ID: 2023-507259-31-00
What this study is testing
The main objective is to investigate the pain-relieving effect of perineural botox injection in patients with chronic cutaneous neuropathic pain
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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)
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.