NCT03604068

Pulsed Short Wave Therapy In Cesarean Section

Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: BioElectronics Corporation · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

Detailed description

Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	RecoveryRx	A pulsed shortwave therapy medical device
DEVICE	Sham RecoveryRx	A sham pulsed shortwave therapy medical device

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-30
• First posted: 2018-07-27
• Last updated: 2018-07-27

Locations

2 sites across 1 country: Lebanon

Regulatory

• FDA-regulated device study