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

Jitka Fricova

Status: Completed

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

Treatments: Procedure: Lesion-Specific Surgical Correction; Procedure: Median Nerve Decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT07263256

CRPS-MND-2014-2023

MH CZ-DRO-VFN64165 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Arm A - Lesion-Specific Surgical Correction

Active Comparator group

Description:

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

Treatment:

Procedure: Lesion-Specific Surgical Correction

Arm B - Median Nerve Decompression

Active Comparator group

Description:

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

Treatment:

Procedure: Median Nerve Decompression