Pulsed Short Wave Therapy In Cesarean Section
Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
1 other identifier
interventional
250
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Apr 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedJuly 27, 2018
May 1, 2018
8 months
June 5, 2018
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Use
Quantify the use of analgesic medications during 7 days of postoperative recovery.
Data collected daily for 7 Days
Secondary Outcomes (3)
Change in Visual Analogue Pain
Data collected for 7 Days
Time to patient Patient Mobility
2 Days
Would Closure at Day 7, Wound Complications
7 Days
Study Arms (2)
Active Group
ACTIVE COMPARATORPatients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as an active RecoveryRx Pulsed Short Wave Therapy device.
Control Group
SHAM COMPARATORPatients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as a sham RecoveryRx Pulsed Short Wave Therapy device.
Interventions
A pulsed shortwave therapy medical device
A sham pulsed shortwave therapy medical device
Eligibility Criteria
You may qualify if:
- Voluntarily
- Performed using spinal anesthesia
- ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)
- PARA 0000, 1, 2, 3 \[i.e. First, Second, or Third C-Section)
- At term pregnancy (\>38 weeks)
- BMI \<35
- Age between 18 - 50 years
You may not qualify if:
- Longitudinal surgical incision
- Placental abnormalities noted
- Time of extraction of the fetus \>10 min from cutaneous incision
- Blood loss during surgery of \>800 ml
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Haykal hospital
Tripoli, Lebanon
New Mazloum Hospital
Tripoli, Lebanon
Related Publications (1)
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PMID: 32871021DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moustafa Chaaban, MD
Haykal hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2018
First Posted
July 27, 2018
Study Start
April 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 30, 2018
Last Updated
July 27, 2018
Record last verified: 2018-05