Median Nerve Decompression for Complex Regional Pain Syndrome: A Clinical Study (CRPS-SURG)

December 4, 2025 updated by: Jitka Fricova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Nové Město na Moravě, Czech Republic, Czechia, 592 31
        • Hospital Nové Město na Moravě

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 10-12 days post-op, 3 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jitka Fricova

Collaborators

Charles University, Czech Republic
General University Hospital, Prague
Ministry of Health, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRPS-MND-2014-2023
  • MH CZ-DRO-VFN64165 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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