Surgical Treatment of Complex Regional Pain Syndrome by Median Nerve Decompression and Lesion-Specific Correction: A Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Change in Pain (VAS Score)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jitka Fricova
Head of Pain Management Center,MD, PhD. Ass.prof.
Charles University, Czech Republic
