Clinical trial NCT06057792: Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment
Official title: Elastography Changes in Cesarean Scar After Negative Pulsed Pressure Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Scar
Elastography
Keywords: elastography
cesarean
adherences
negative pulsed pressure
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Participants will be recruited at the "Clínica Ana González" physiotherapy clinic. Once recruited, the physiotherapist Ana González Muñoz will carry out the assessment to determine the degree of eligibility of said participants and their inclusion or not in the study. The present study is designed as an open, controlled clinical trial. Two evaluations will be carried out on each participant before and after treatment. Participants who meet the required inclusion/exclusion criteria determined below will be included.

Participants will receive a Negative Pulsed Pressure treatment program with the AeroFlow® equipment. The measuring instruments to be used will be:

- Ultrasound machine.

Description of the ultrasound evaluation

Ultrasound evaluations will be performed. The participant will remain in all measurements. All measurements will be performed with a General Electric S7 R3 The evaluation of tissue quality will be carried out by pixel quantification, using the computer software included in the ultrasound equipment itself.

* Adheremeter Adheremeter is a new device designed to measure postsurgical scar adhesion which is defined as the restriction of scar mobility with respect to the underlying tissue of the point of worst adhesion when stretched in four orthogonal directions. It is an economical and easy-to-use instrument with an ergonomic shape, consisting of 9 concentric rings with radii of 1, 2, 4, 6, 8, 10, 12, 14 and 15 mm, respectively, printed on flexible transparency film for photocopiers. (manufacturer part number PP2500 - 3MTM, St. Paul, MN, USA) to ensure maximum adaptability to different anatomical surfaces.
* Foot posture index (FPI):The foot posture index (FPI) is a reliable instrument for this purpose, assuming a diagnostic tool whose purpose is to quantify the degree of neutral, pronated or supinated position of the foot. The following FPI cut-off points are used, which define the foot type category: a) very supinated from -12 to -4, b) supinated from -3 to 0, c) neutral from 1 to 6, d) pronated from 6 to 10 and e) very pronated from 11 to 12.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: elastography measurement
timeFrame: 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:
measure: adheremeter measurement
timeFrame: 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.
measure: Foot posture index
timeFrame: 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.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Ana González
city: Málaga
country: Spain
facility: Clínica Ana González
Study officials:
References: