NCT06057792

Brief Summary

The application of pulsed negative pressure to the scar tissue stimulates the cellular response, producing elastic changes in the tissue, quantifiable by ultrasound, not only in terms of thickness but also in the elastic capacity of the tissues, measured by quantified elastography.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

September 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 12, 2023

Last Update Submit

October 22, 2023

Conditions

Cesarean ScarElastography

Keywords

elastographycesareanadherencesnegative pulsed pressure

Outcome Measures

Primary Outcomes (1)

  • elastography measurement

    The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.

    Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.

Secondary Outcomes (2)

  • adheremeter measurement

    Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.

  • Foot posture index

    Time0 (T0) FIRST DAY BEFORE FIRST TREATMENT, TIME 1 (T1) FIRST DAY AFTER FIRST TREATMENT, TIME 2 (T2) AFTER 6 DAY OF TREATMENT (THE THIRD WEEK) , TIME 3(T3) 15 DAYS AFTER THE SIXTH TREATMENT, TIME 4 (T4) ONE MONTH AFTER THE SIXTH TREATMENT.

Study Arms (1)

NEGATIVE PULSED PRESSURE INTERVENTION GROUP

EXPERIMENTAL

The number of treatment sessions will consist of a total of 6 sessions, so there will be two sessions over 3 weeks. The evaluations of the participants will be carried out before and after the first session, after the last session of the treatment program received, 15 days and one month after finishing the treatment.

Device: negative pulsed pressure AeroFlow system

Interventions

negative pulsed pressure AeroFlow systemDEVICE

For the application of pulsatile negative pressure, the AeroFlow® equipment will be used, carried out by one of the researchers participating in the project.The application will be carried out addressing the structure of interest (scar), following the protocol established by INDIBA to release adhesions between the different depth planes. The work will consist of an application of pulsed negative pressure using suction cups, which will work automatically at a frequency and intensity tolerable by the patient. Treatment protocol in 2 phases Total application time 15min 1. Static cup: preparation: Prepare the tissue surrounding the scar. 5min 2. Dynamic Cup: work: Lock the tissue around the scar and the scar itself.10min Suction mode: continuous with continuous sliding of the cup The number of treatment sessions will consist of a total of 6 sessions, so there will be two sessions over 3 weeks.

NEGATIVE PULSED PRESSURE INTERVENTION GROUP

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants aged between 18 and 60 years
  • Who have undergone cesarean section surgery and therefore have a scar, lasting more than six months and less than 2 years.
  • Patients who present a post-cesarean section scar with a fibrotic appearance and possible surrounding fascial restrictions.

You may not qualify if:

  • Patients who present any neurological, inflammatory or orthopedic injury that prevents or alters balance, listening, vision or the cognitive abilities necessary to be able to answer appropriate questions or take questionnaires.
  • Patients who present keloids in the scar.
  • Patients who have contraindications to be treated with a 448kHz radiofrequency device such as:
  • to. pregnant women b. Subjects with any type of electronic implants. c. Subjects presenting with thrombophlebitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ana González

Málaga, 29018, Spain

Location

Clínica Ana González

Málaga, 29018, Spain

Location

Central Study Contacts

ANA GONZÁLEZ

CONTACT

661236109ANAGONZALEZ.FISIOTERAPEUTA@GMAIL.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, MSc

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 28, 2023

Study Start

October 30, 2023

Primary Completion

February 11, 2024

Study Completion

June 30, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

ES(2)