Pulsed Short Wave Therapy In Cesarean Section

NCT ID: NCT03604068

Last Updated: 2018-07-27

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

RecoveryRx

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Sham RecoveryRx

Intervention Type DEVICE

A sham pulsed shortwave therapy medical device

Interventions

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RecoveryRx

A pulsed shortwave therapy medical device

Intervention Type DEVICE

Sham RecoveryRx

A sham pulsed shortwave therapy medical device

Intervention Type DEVICE

Other Intervention Names

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pulsed shortwave therapy Sham pulsed shortwave therapy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Longitudinal surgical incision
* Placental abnormalities noted
* Time of extraction of the fetus \>10 min from cutaneous incision
* Blood loss during surgery of \>800 ml
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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BioElectronics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moustafa Chaaban, MD

Role: PRINCIPAL_INVESTIGATOR

Haykal hospital

Locations

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Haykal hospital

Tripoli, , Lebanon

Site Status RECRUITING

New Mazloum Hospital

Tripoli, , Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Mahmoud Maassarani, Ph.D

Role: CONTACT

Omar Tabbouche, Pharma D

Role: CONTACT

Facility Contacts

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Omar Tabbouche, Pharm D

Role: primary

+9613433032

Mahmoud Maassarani, Ph.D

Role: primary

96179156547

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.

Reference Type DERIVED
PMID: 32871021 (View on PubMed)

Other Identifiers

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PRO180401

Identifier Type: -

Identifier Source: org_study_id

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