Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2018-04-01
2018-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Group
Patients 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.
RecoveryRx
A pulsed shortwave therapy medical device
Control Group
Patients 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.
Sham RecoveryRx
A sham pulsed shortwave therapy medical device
Interventions
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RecoveryRx
A pulsed shortwave therapy medical device
Sham RecoveryRx
A sham pulsed shortwave therapy medical device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Placental abnormalities noted
* Time of extraction of the fetus \>10 min from cutaneous incision
* Blood loss during surgery of \>800 ml
18 Years
50 Years
FEMALE
Yes
Sponsors
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BioElectronics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Moustafa Chaaban, MD
Role: PRINCIPAL_INVESTIGATOR
Haykal hospital
Locations
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Haykal hospital
Tripoli, , Lebanon
New Mazloum Hospital
Tripoli, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PRO180401
Identifier Type: -
Identifier Source: org_study_id
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