CClinicalTrials.gg
CompletedNCT07263256CRPS-SURGUpdated Dec 12, 2025

Median Nerve Decompression for Complex Regional Pain Syndrome: A Clinical Study

An interventional study of Lesion-Specific Surgical Correction and Median Nerve Decompression in Complex Regional Pain Syndrome I (CRPS I) and Nerve Entrapment Syndrome, sponsored by Jitka Fricova. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Jitka Fricova · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Complex Regional Pain Syndrome I (CRPS I)
  • Nerve Entrapment Syndrome

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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Active comparator
    Arm A - Lesion-Specific Surgical Correction

    Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of CRPS.

    Procedure: Lesion-Specific Surgical Correction

  • Active comparator
    Arm B - Median Nerve Decompression

    Open decompression of the median nerve performed in patients without identifiable lesions but with nocturnal neuropathic pain suggestive of median nerve irritation.

    Procedure: Median Nerve Decompression

Interventions

  • ProcedureLesion-Specific Surgical Correction

    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.

  • ProcedureMedian Nerve Decompression

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 10-12 days post-op, 3 months post-op

06

Study locations

1 site
  • Hospital Nové Město Na Moravě
    Nové Město na Moravě, Czech Republic 592 31, Czechia
07

References and documents

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 19557864 ↗
  • Goebel 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07263256
Lead sponsor
Jitka Fricova
Collaborators
Charles University, Czech Republic, Ministry of Health, Czech Republic, General University Hospital, Prague
Responsible party
Jitka Fricova (Head of Pain Management Center,MD, PhD. Ass.prof., Charles University, Czech Republic) — Sponsor-investigator
First posted
Dec 4, 2025
Start date
Jan 2014
Primary completion
Dec 2023
Completion
Dec 2023
Last update
Dec 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion