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

NCT07263256 | Completed

• 2 other identifiers: CRPS-MND-2014-2023MH CZ-DRO-VFN64165
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  Baseline, 10-12 days post-op, 3 months post-op

Study Arms (2)

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.

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.

Procedure: Median Nerve Decompression

Interventions

Lesion-Specific Surgical Correction PROCEDURE

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.

Arm A - Lesion-Specific Surgical Correction

Median Nerve Decompression PROCEDURE

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.

Arm B - Median Nerve Decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: collaborator
• Ministry of Health, Czech Republic: collaborator
• General University Hospital, Prague: collaborator
• Jitka Fricova: lead

Study Sites (1)

Hospital Nové Město Na Moravě

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

Location

Related Publications (3)

• 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.

  PMID: 19557864 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20493633 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Charcot-Marie-Tooth Disease; Reflex Sympathetic Dystrophy; Neuralgia; Nerve Compression Syndromes; Chronic Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pain Management Center,MD, PhD. Ass.prof.

Model Details: Parallel Assignment Group A: Lesion-specific correction Group B: Median nerve decompression

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)