CRPS (Complex Regional Pain Syndromes)PINComNCT07473635
Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study
A study testing Perineural Incobotulinumtoxin-A 200 U in people with CRPS (Complex Regional Pain Syndromes) and CRPS (Complex Regional Pain Syndrome) Type I, run by Bo Biering-Soerensen at 1 site in Denmark.
Trial summary
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRPS (Complex Regional Pain Syndromes), CRPS (Complex Regional Pain Syndrome) Type I, CRPS Type II
- What is being tested?
- Perineural Incobotulinumtoxin-A 200 U
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jan 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are over the age of 18
- Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- Have had the condition for at least 6 months
- Rate CRPS as their primary pain condition
- Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this regimen throughout the study
- For pre-menopausal females: are using a safe and approved contraceptive
- Speak, read, and understand Danish
Who cannot join
- Are allergic to botulinum toxin A
- Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of CRPS-specific pain difficult
- Have an ongoing infection in the affected limb
- Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
- Have used a topical analgesic treatment such as lidocaine patches within 1 week prior to study start or have been treated with capsaicin patches in the affected area within 3 months prior to study start
Show all 11Show fewer
- Have psychiatric comorbidities which are considered by the investigators to impact their ability to participate
- Consume alcohol in excess of what is recommended by the Danish Health Ministry
- Are active abusers of illicit narcotics
- Are pregnant, lactating, or plan on becoming pregnant during the study period
- Have any other condition or circumstance that, in the investigators' opinion, will hinder safe and timely participation and completion of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
CRPS- and Nerve Pain Clinic, Rigshospitalet Glostrup
Glostrup, Region Sjælland, 2600
Marc K Olsen, MD, +4538633030, marc.klee.olsen@regionh.dk
About this study
Official title: Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (PINCom)
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by invasive procedures.
Perineural administration of botulinum toxin A has shown analgesic effects in other neuropathic pain conditions and may represent a less painful alternative to subcutaneous injection techniques. However, the feasibility, tolerability, and safety of perineural botulinum toxin administration in patients with CRPS have not been systematically evaluated.
Read more
The PINCom study is a single-center, open-label feasibility study designed to assess the safety, tolerability, and practical feasibility of ultrasound-guided perineural injection of incobotulinumtoxin-A in patients with unilateral chronic CRPS affecting an upper or lower limb. Participants receive a single perineural injection targeting major sensory nerves supplying the affected limb and are followed for 12 weeks.
Primary outcomes focus on feasibility metrics, including recruitment, retention, adherence, and data completeness, as well as safety outcomes, including serious adverse events and procedure-related complications. Tolerability is assessed through monitoring of CRPS flare-ups and a dedicated qualitative interview exploring participant experience. Exploratory outcomes include pain intensity, CRPS severity, and patient-reported measures collected to inform the design of a future randomized controlled trial.
Read the detailed description
The PINCom study is a single-center, open-label feasibility study designed to evaluate the practical feasibility, safety, and tolerability of ultrasound-guided perineural injection of incobotulinumtoxin-A in adults with unilateral CRPS of an upper or lower limb. Depending on the anatomical distribution of symptoms, injections are administered at the supraclavicular brachial plexus (upper limb) or at distal sciatic and/or femoral nerve targets (lower limb). All procedures are performed under ultrasound guidance in a single treatment session.
The primary objective of the study is to determine whether a larger randomized controlled trial of perineural incobotulinumtoxin-A in CRPS is feasible at the study center. Feasibility outcomes include recruitment rate, screening-to-enrollment ratio, retention, adherence to study visits and daily pain diary completion, and completeness of outcome data.
Safety is assessed through monitoring of serious adverse events and targeted screening for procedure-related complications, potential nerve injury, and signs of systemic botulinum toxin spread. Adverse events are recorded throughout the study period. Given the clinical characteristics of CRPS, flare-ups are monitored separately as a tolerability outcome rather than as a primary safety endpoint.
Tolerability and participant experience are evaluated using a combination of structured symptom monitoring and a semi-structured qualitative interview conducted during follow-up. The interview explores participants' experiences of the injection procedure, perceived burden of study participation, and acceptability of the intervention. This qualitative component is intended to inform protocol refinement and patient-centered trial design.
Exploratory clinical outcomes are collected to characterize symptom variability and inform future trial design. These include daily pain intensity ratings, CRPS Severity Score assessments, sensory symptom mapping, and patient-reported outcome measures assessing pain quality, psychological factors, physical function, and quality of life. These measures are not powered to assess efficacy but will be used to estimate variability and optimal outcome timing for a future definitive trial.
Participants are followed for 12 weeks after treatment. Findings from this feasibility study will be used to guide decisions regarding the design, outcome selection, and operational aspects of a subsequent randomized controlled trial evaluating perineural incobotulinumtoxin-A for the treatment of CRPS.
- Conditions
- CRPS (Complex Regional Pain Syndromes), CRPS (Complex Regional Pain Syndrome) Type I, CRPS Type II
- Being tested
- Perineural Incobotulinumtoxin-A 200 U
- Keywords
- botulinum toxin, CRPS, Pilot, perineural
- Medical subject headings
- Complex Regional Pain Syndromes, Causalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural Incobotulinumtoxin-A 200 UDrug
Single perineural injection of 200 U iBonT-A around the brachial plexus in the case of upper limb CRPS, or 150 U iBonT-A around the distal ischial nerve and 50 U around the saphenus nerve in the case of lower limb CRPS.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Open-label treatment with 200 U of perineural Xeomin, either around the brachial plexus or the distal ischial and saphenus nerves. Receives: Drug: Perineural Incobotulinumtoxin-A 200 U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants enrolled over time in the study
Measured: From study start through Day 84 (12 weeks)
Screening-to-enrolment ratio
Proportion of screened patients who are enrolled in the study.
Measured: From study start through Day 84
Study completion rate
Proportion of enrolled participants completing the study per protocol
Measured: Day -7 to 84
Completeness of study data
Proportion of expected study data successfully collected, including completion of scheduled study visits and daily pain diary entries.
Measured: Day -7 to 84
Secondary outcomes (3)
Serious Adverse Events (SAEs)
Occurrence of serious adverse events related to the perineural injection procedure or investigational medicinal product, assessed to evaluate procedural safety.
Measured: From treatment (Day 0) through Day 84
CRPS flare-ups
Incidence, severity, and duration of CRPS flare-ups following perineural incobotulinumtoxin-A injection. A flare-up is defined as an exacerbation, worsening, or new appearance of CRPS-related symptoms lasting at least 24 hours following a provoking event. Flare-ups are assessed as a tolerability outcome rather than a safety endpoint.
Measured: From treatment (Day 0) through Day 84
Participant-reported acceptability and experience
Participant experience and acceptability of the injection procedure and study participation, assessed using a semi-structured qualitative interview focusing on procedural burden, tolerability, and perceived acceptability.
Measured: From enrolment to day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start7 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPS (Complex Regional Pain Syndromes)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Biering-Soerensen
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH, University of Copenhagen
- Responsible party
- Sponsor-investigator, Bo Biering-Soerensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473635
- Sponsor's protocol ID
- PINCom
- Other IDs
- 2024-519832-17-00
- Acronym
- PINCom
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications from this study will be made available upon reasonable request. Data will be shared after publication of the primary results and following completion of all planned analyses. Requests will be reviewed by the study investigators and may require approval by relevant institutional and data protection authorities, as well as execution of a data use agreement. Shared data will be limited to variables necessary to achieve the stated research objectives and will not include information that could reasonably be used to re-identify participants.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (PINCom)
- ClinicalTrials.gov ID
- NCT07473635
- Acronym / sponsor ID
- PINCom / PINCom
- Conditions
- CRPS (Complex Regional Pain Syndromes), CRPS (Complex Regional Pain Syndrome) Type I, CRPS Type II
- Keywords
- botulinum toxin, CRPS, Pilot, perineural
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bo Biering-SoerensenUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH, University of Copenhagen
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by invasive procedures.
Perineural administration of botulinum toxin A has shown analgesic effects in other neuropathic pain conditions and may represent a less painful alternative to subcutaneous injection techniques. However, the feasibility, tolerability, and safety of perineural botulinum toxin administration in patients with CRPS have not been systematically evaluated.
The PINCom study is a single-center, open-label feasibility study designed to assess the safety, tolerability, and practical feasibility of ultrasound-guided perineural injection of incobotulinumtoxin-A in patients with unilateral chronic CRPS affecting an upper or lower limb. Participants receive a single perineural injection targeting major sensory nerves supplying the affected limb and are followed for 12 weeks.
Primary outcomes focus on feasibility metrics, including recruitment, retention, adherence, and data completeness, as well as safety outcomes, including serious adverse events and procedure-related complications. Tolerability is assessed through monitoring of CRPS flare-ups and a dedicated qualitative interview exploring participant experience. Exploratory outcomes include pain intensity, CRPS severity, and patient-reported measures collected to inform the design of a future randomized controlled trial.
Detailed description
The PINCom study is a single-center, open-label feasibility study designed to evaluate the practical feasibility, safety, and tolerability of ultrasound-guided perineural injection of incobotulinumtoxin-A in adults with unilateral CRPS of an upper or lower limb. Depending on the anatomical distribution of symptoms, injections are administered at the supraclavicular brachial plexus (upper limb) or at distal sciatic and/or femoral nerve targets (lower limb). All procedures are performed under ultrasound guidance in a single treatment session.
The primary objective of the study is to determine whether a larger randomized controlled trial of perineural incobotulinumtoxin-A in CRPS is feasible at the study center. Feasibility outcomes include recruitment rate, screening-to-enrollment ratio, retention, adherence to study visits and daily pain diary completion, and completeness of outcome data.
Safety is assessed through monitoring of serious adverse events and targeted screening for procedure-related complications, potential nerve injury, and signs of systemic botulinum toxin spread. Adverse events are recorded throughout the study period. Given the clinical characteristics of CRPS, flare-ups are monitored separately as a tolerability outcome rather than as a primary safety endpoint.
Tolerability and participant experience are evaluated using a combination of structured symptom monitoring and a semi-structured qualitative interview conducted during follow-up. The interview explores participants' experiences of the injection procedure, perceived burden of study participation, and acceptability of the intervention. This qualitative component is intended to inform protocol refinement and patient-centered trial design.
Exploratory clinical outcomes are collected to characterize symptom variability and inform future trial design. These include daily pain intensity ratings, CRPS Severity Score assessments, sensory symptom mapping, and patient-reported outcome measures assessing pain quality, psychological factors, physical function, and quality of life. These measures are not powered to assess efficacy but will be used to estimate variability and optimal outcome timing for a future definitive trial.
Participants are followed for 12 weeks after treatment. Findings from this feasibility study will be used to guide decisions regarding the design, outcome selection, and operational aspects of a subsequent randomized controlled trial evaluating perineural incobotulinumtoxin-A for the treatment of CRPS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Perineural Incobotulinumtoxin-A 200 UOpen-label treatment with 200 U of perineural Xeomin, either around the brachial plexus or the distal ischial and saphenus nerves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are over the age of 18
- Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- Have had the condition for at least 6 months
- Rate CRPS as their primary pain condition
- Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this regimen throughout the study
Key exclusion criteria (11 listed)
- Are allergic to botulinum toxin A
- Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of CRPS-specific pain difficult
- Have an ongoing infection in the affected limb
- Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineural Incobotulinumtoxin-A 200 USingle perineural injection of 200 U iBonT-A around the brachial plexus in the case of upper limb CRPS, or 150 U iBonT-A around the distal ischial nerve and 50 U around the saphenus nerve in the case of lower limb CRPS. | Drug | Active |
Primary outcome
Recruitment rate
Time frame: From study start through Day 84 (12 weeks)
Number of participants enrolled over time in the study
Screening-to-enrolment ratio
Time frame: From study start through Day 84
Proportion of screened patients who are enrolled in the study.
Study completion rate
Time frame: Day -7 to 84
Proportion of enrolled participants completing the study per protocol
Completeness of study data
Time frame: Day -7 to 84
Proportion of expected study data successfully collected, including completion of scheduled study visits and daily pain diary entries.
3 secondary outcomes
Serious Adverse Events (SAEs)
Time frame: From treatment (Day 0) through Day 84
CRPS flare-ups
Time frame: From treatment (Day 0) through Day 84
Participant-reported acceptability and experience
Time frame: From enrolment to day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications from this study will be made available upon reasonable request. Data will be shared after publication of the primary results and following completion of all planned analyses. Requests will be reviewed by the study investigators and may require approval by relevant institutional and data protection authorities, as well as execution of a data use agreement. Shared data will be limited to variables necessary to achieve the stated research objectives and will not include information that could reasonably be used to re-identify participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural Incobotulinumtoxin-A 200 U in people with CRPS (Complex Regional Pain Syndromes) and CRPS (Complex Regional Pain Syndrome) Type I, run by Bo Biering-Soerensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc K Olsen, MD (+45 38633030, marc.klee.olsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From study start through Day 84 (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.