Complex Regional Pain Syndrome Type I

A Phase 3 open-label extension study of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

Phase 3 Trial of AMBTX-01 (neridronate) for Complex Regional Pain Syndrome Type 1

This randomized, participant- and assessor-blinded, sham-controlled study will evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) added to standard rehabilitation in adults with complex regional pain syndrome type I (CRPS-I) affecting the hand or upper extremity. A total of 20 participants will be randomly assigned to two parallel groups. Both groups will receive the same standard rehabilitation program 5 days per week for 4 weeks. In addition, the experimental group will receive active taVNS, while the control group will receive sham taVNS for 30 minutes per session over the same 4-week period. The primary outcome is change in pain intensity measured using the Numerical Rating Scale. Secondary outcomes include CRPS clinical severity, hand and wrist circumference, hand function and activities of daily living, health-related quality of life, anxiety and depression symptoms, and perceived stress. Assessments will be performed at baseline, at the end of treatment at week 4, and during follow-up at weeks 8 and 12.

The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture.