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

NCT ID: NCT07263256

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2023-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lesion-Specific Surgical Correction

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Median Nerve Decompression

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: collaborator

Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: collaborator

Jitka Fricova

OTHER

Sponsor Role: lead

Responsible Party

Jitka Fricova

Head of Pain Management Center,MD, PhD. Ass.prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Nové Město Na Moravě

Nové Město na Moravě, Czech Republic, Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 19557864 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 20493633 (View on PubMed)

Other Identifiers

MH CZ-DRO-VFN64165

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRPS-MND-2014-2023

Identifier Type: -

Identifier Source: org_study_id