Complex Regional Pain Syndrome I (CRPS I)CRPS-SURGNCT07263256
Median Nerve Decompression for Complex Regional Pain Syndrome: A Clinical Study
A study testing Lesion-Specific Surgical Correction and Median Nerve Decompression in people with Complex Regional Pain Syndrome I (CRPS I) and Nerve Entrapment Syndrome, run by Jitka Fricova at 1 site in Czechia.
Trial summary
This clinical study evaluates the effectiveness of surgical treatment in patients with upper-limb complex regional pain syndrome (CRPS) diagnosed according to the Budapest criteria. Seventy-four patients were assessed between 2014 and 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome I (CRPS I), Nerve Entrapment Syndrome
- What is being tested?
- Lesion-Specific Surgical Correction and Median Nerve Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2014to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosed Complex Regional Pain Syndrome (CRPS) according to Budapest criteria
- Age ≥ 18 years
- Persistent symptoms despite previous conservative treatment
- Ability to understand the study information and provide informed consent
- Ability to adhere to postoperative follow-up
Who cannot join
- Active local or systemic infection
- Severe uncontrolled psychiatric illness
- Coagulopathy or anticoagulation therapy contraindicating surgery
- Pregnancy
- Previous extensive surgical interventions on the same site interfering with planned procedure
- Inability to comply with follow-up
- Any other condition that, in the opinion of the investigator, makes participation unsafe
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Hospital Nové Město Na Moravě
Nové Město na Moravě, Czech Republic, 592 31
About this study
Official title: Surgical Treatment of Complex Regional Pain Syndrome by Median Nerve Decompression and Lesion-Specific Correction: A Clinical Study
This clinical study evaluates the effectiveness of surgical treatment in patients with upper-limb complex regional pain syndrome (CRPS) diagnosed according to the Budapest criteria. Seventy-four patients were assessed between 2014 and 2023. Patients with identifiable structural pathology underwent lesion-specific surgical correction, while those without detectable lesions but with neuropathic nocturnal pain underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) preoperatively, at 10-12 days, and at three months. The study aims to determine the speed and magnitude of pain improvement after targeted surgical intervention.
Read the detailed description
Complex regional pain syndrome (CRPS) is a multifactorial neuropathic pain disorder that can occur after trauma or surgery and is often resistant to conservative treatment. Increasing evidence suggests that in a subset of patients, peripheral mechanical factors contribute significantly to symptom generation. This prospective clinical study evaluated the outcomes of targeted surgical treatment in patients with CRPS of the upper limb who met the Budapest diagnostic criteria.
From 2014 to 2023, seventy-four patients were examined. Thirty-eight patients presented with identifiable structural pathology, such as hardware impingement, neuroma, tendon adhesion, or scar tethering, and underwent lesion-specific surgical correction. Thirty-six patients had no detectable structural lesion but reported nocturnal neuropathic pain suggestive of median nerve irritation; these patients underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) before surgery, at suture removal (10-12 days), and at three months postoperatively.
Patients with identifiable mechanical pathology demonstrated substantial improvement, with an average 7.2-point VAS reduction after six months. Patients who underwent median nerve decompression showed rapid and marked pain reduction, improving by 7.1 points within 10-12 days and 8.6 points within three months. Acute CRPS cases improved more than chronic ones, indicating an early therapeutic window before central sensitization becomes dominant. Only one chronic case failed to improve. The results suggest that timely surgical assessment and correction of peripheral nerve or soft-tissue factors may lead to rapid and significant clinical recovery in selected CRPS patients.
- Being tested
- Lesion-Specific Surgical Correction, Median Nerve Decompression
- Keywords
- Complex Regional Pain Syndrome, CRPS Type I, Neuropathic Pain, Median Nerve Decompression, Peripheral Nerve Surgery, Upper Limb Pain, Nerve Entrapment, Chronic Pain, Hand Surgery
- Medical subject headings
- Complex Regional Pain Syndromes, Charcot-Marie-Tooth Disease, Reflex Sympathetic Dystrophy, Neuralgia, Nerve Compression Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesion-Specific Surgical CorrectionProcedure or surgery
Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb.
Median Nerve DecompressionProcedure or surgery
Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Lesion-Specific Surgical Correction | Active comparator | Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of CRPS. Receives: Procedure: Lesion-Specific Surgical Correction |
| Arm B - Median Nerve Decompression | Active comparator | Open decompression of the median nerve performed in patients without identifiable lesions but with nocturnal neuropathic pain suggestive of median nerve irritation. Receives: Procedure: Median Nerve Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain (VAS Score)
Change in pain intensity measured using the visual analogue scale (0-10) to evaluate the clinical effect of surgical intervention.
Measured: Baseline, 10-12 days post-op, 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startJan 2014
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome I (CRPS I)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Group A: Lesion-specific correction Group B: Median nerve decompression
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jitka Fricova
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Ministry of Health, Czech Republic, General University Hospital, Prague
- Responsible party
- Sponsor-investigator, Jitka Fricova, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263256
- Sponsor's protocol ID
- CRPS-MND-2014-2023
- Other IDs
- MH CZ-DRO-VFN64165
- Acronym
- CRPS-SURG
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oaklander AL, Fields HL. Is reflex sympathetic dystrophy/complex regional pain syndrome type I a small-fiber neuropathy? Ann Neurol. 2009 Jun;65(6):629-38. doi: 10.1002/ana.21692.
PubMed 19557864Goebel A, Barker CH, Turner-Stokes L, et al. Complex regional pain syndrome in adults: UK guidelines for diagnosis, referral and management. Rheumatology (Oxford). 2018;57(8):1405-1436. PMID: 29648652
Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.
PubMed 20493633
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Complex Regional Pain Syndrome by Median Nerve Decompression and Lesion-Specific Correction: A Clinical Study
- ClinicalTrials.gov ID
- NCT07263256
- Acronym / sponsor ID
- CRPS-SURG / CRPS-MND-2014-2023
- Keywords
- Complex Regional Pain Syndrome, CRPS Type I, Neuropathic Pain, Median Nerve Decompression, Peripheral Nerve Surgery, Upper Limb Pain, Nerve Entrapment, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Jitka FricovaUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Ministry of Health, Czech Republic, General University Hospital, Prague
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 4 Dec 2025 (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.
This clinical study evaluates the effectiveness of surgical treatment in patients with upper-limb complex regional pain syndrome (CRPS) diagnosed according to the Budapest criteria. Seventy-four patients were assessed between 2014 and 2023. Patients with identifiable structural pathology underwent lesion-specific surgical correction, while those without detectable lesions but with neuropathic nocturnal pain underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) preoperatively, at 10-12 days, and at three months. The study aims to determine the speed and magnitude of pain improvement after targeted surgical intervention.
Detailed description
Complex regional pain syndrome (CRPS) is a multifactorial neuropathic pain disorder that can occur after trauma or surgery and is often resistant to conservative treatment. Increasing evidence suggests that in a subset of patients, peripheral mechanical factors contribute significantly to symptom generation. This prospective clinical study evaluated the outcomes of targeted surgical treatment in patients with CRPS of the upper limb who met the Budapest diagnostic criteria.
From 2014 to 2023, seventy-four patients were examined. Thirty-eight patients presented with identifiable structural pathology, such as hardware impingement, neuroma, tendon adhesion, or scar tethering, and underwent lesion-specific surgical correction. Thirty-six patients had no detectable structural lesion but reported nocturnal neuropathic pain suggestive of median nerve irritation; these patients underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) before surgery, at suture removal (10-12 days), and at three months postoperatively.
Patients with identifiable mechanical pathology demonstrated substantial improvement, with an average 7.2-point VAS reduction after six months. Patients who underwent median nerve decompression showed rapid and marked pain reduction, improving by 7.1 points within 10-12 days and 8.6 points within three months. Acute CRPS cases improved more than chronic ones, indicating an early therapeutic window before central sensitization becomes dominant. Only one chronic case failed to improve. The results suggest that timely surgical assessment and correction of peripheral nerve or soft-tissue factors may lead to rapid and significant clinical recovery in selected CRPS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Group A: Lesion-specific correction Group B: Median nerve decompression
| Arm | Type | Receives |
|---|---|---|
| Arm A - Lesion-Specific Surgical Correction | Active comparator | Procedure: Lesion-Specific Surgical CorrectionSurgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of CRPS. |
| Arm B - Median Nerve Decompression | Active comparator | Procedure: Median Nerve DecompressionOpen decompression of the median nerve performed in patients without identifiable lesions but with nocturnal neuropathic pain suggestive of median nerve irritation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed Complex Regional Pain Syndrome (CRPS) according to Budapest criteria
- Age ≥ 18 years
- Persistent symptoms despite previous conservative treatment
- Ability to understand the study information and provide informed consent
- Ability to adhere to postoperative follow-up
Key exclusion criteria (7 listed)
- Active local or systemic infection
- Severe uncontrolled psychiatric illness
- Coagulopathy or anticoagulation therapy contraindicating surgery
- Pregnancy
- Previous extensive surgical interventions on the same site interfering with planned procedure
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 |
|---|---|---|
| Lesion-Specific Surgical CorrectionSurgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb. | Procedure or surgery | Arm A - Lesion-Specific Surgical Correction |
| Median Nerve DecompressionSurgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb. | Procedure or surgery | Arm B - Median Nerve Decompression |
Primary outcome
Change in Pain (VAS Score)
Time frame: Baseline, 10-12 days post-op, 3 months post-op
Change in pain intensity measured using the visual analogue scale (0-10) to evaluate the clinical effect of surgical intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 19557864Oaklander AL, Fields HL. Is reflex sympathetic dystrophy/complex regional pain syndrome type I a small-fiber neuropathy? Ann Neurol. 2009 Jun;65(6):629-38. doi: 10.1002/ana.21692.
- BackgroundGoebel A, Barker CH, Turner-Stokes L, et al. Complex regional pain syndrome in adults: UK guidelines for diagnosis, referral and management. Rheumatology (Oxford). 2018;57(8):1405-1436. PMID: 29648652
- Background: PubMed 20493633Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lesion-Specific Surgical Correction and Median Nerve Decompression in people with Complex Regional Pain Syndrome I (CRPS I) and Nerve Entrapment Syndrome, run by Jitka Fricova at 1 site in Czechia.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Dec 2025. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (VAS Score) (time frame: Baseline, 10-12 days post-op, 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07263256, which also lists 3 linked publications.
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 12 Dec 2025.