Exploring the Effects of Soft Tissue Manual Therapy on Caesarean Section Scar

NCT04320355 | Completed

• 1 other identifier: 2020-3351
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

Introduction: Caesarean section is one of the most common inpatient surgical procedures. Complications of obstetric wounds are estimated to account for 2.8-26.6% of cases. Between 11 and 15% of women would develop pain and discomfort following a Caesarean section. Manual therapies may be an interesting non-pharmacological approach to treating the signs and symptoms of scarring complications following a Caesarean section. However, the current literature with an in vivo perspective remains modest results for the effects of tissue physiology and their effects on pain. Method: Using an exploratory "proof of concept" type descriptive design with before and after measurements, the immediate and 7-day effects following the application of soft tissue manual therapy on the Caesarean section scar will be evaluated. The objectives are to describe and explore differences from the effects of soft tissue manual therapy on the viscoelastic properties, pressure sensitivity and touch sensitivity of the Caesarean section scar. Thirty-eight women aged between 18 and 40 years with a Caesarean section scar who attend first-line or specialized obstetrics and perinatal clinics will be recruited. Anticipated results This project will document the viscoelastic characteristics, pressure sensitivity and touch sensitivity of the C-section scar and surrounding unhealed tissue to improve our understanding of the plausibility of the effects of manual therapy, an approach used to treat the signs and symptoms associated with C-section scarring.

Conditions

Cesarean Section Complications

Keywords

Caesarean; Manual therapy; Thresholds; Viscoelastic properties; scar

Outcome Measures

Primary Outcomes (3)

• Viscoelastic properties: Stiffness

  The MyotonPro allows the evaluation of five parameters. Stiffness (N/m) is manifested by the resistance to deformation induced by the applied force of the external mechanical arm.The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties.

  The change in stiffness is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Stiffness will be assessed at the beginning of each visit and following the intervention.

• The viscoelastic properties: Elasticity

  The MyotonPro allows the evaluation of five parameters. The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties. The ability of the tissue to return to its initial shape characterises elasticity (D). This can be identified by the logarithmic decrement, i.e. the logarithmic measurement of the dissipation of mechanical energy induced by the external arm of the MyotonPro.

  The change in Elasticity is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Elasticity will be assessed at the beginning of each visit and following the intervention.

• The viscoelasticity properties: Tone

  The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties. The MyotonPro allows the evaluation of five parameters. The oscillation frequency (Hz) characterizes the resting tone, i.e. the intrinsic cell tension.

  The change in tone is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Tone will be assessed at the beginning of each visit and following the intervention.

Secondary Outcomes (3)

• Pressure sensitivity

  The change in pressure is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Pressure will be assessed at the beginning of each visit and following the intervention.

• Touch sensitivity

  The change in touch sensitivity is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Touch sensitivity will be assessed at the beginning of each visit and following the intervention.

• Appearance of the caesarean section

  The change in appearance is evaluated before the intervention. To evaluate this change, two visits each 7 days are required. Appearance will be assessed at the beginning of each visit.

Study Arms (1)

Soft tissue manual therapy

EXPERIMENTAL

The researcher student will place the gloves with the force sensor on the thumb of her right and left hand. She will evaluate the Caesarean section scar and identify the most rigid scar areas when compression is applied. On these identified areas, the researcher student will apply the manual therapy procedure described in the independent variable (compression + shear) section. This procedure will be applied to all identified rigid areas of the Caesarean section scar.This procedure will last 10 minutes (approximately 2 minutes per rigid area). After this time, the researcher-student will remove the force sensor and leave the room.

Other: Soft tissue manual therapy

Interventions

Soft tissue manual therapy OTHER

The intervention is a type of massage.

Soft tissue manual therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman with a caesarean section scar of 6 months or more but less than two years old
• with one or more caesarean sections
• between the ages of 18 and 40
• with a Pfannenstiel or transverse caesarean section.

You may not qualify if:

• one of the following pathologies: diabetes or under treatment for cancer
• on anti-inflammatory medication at the time of data collection or they have taken this type of medication in the month prior to data collection
• applied a product or cream to their scar on the day of data collection
• contraindications to their skin inductions
• had a treatment (e.g., a treatment to prevent the development of cancer)
• undergoing treatment (e.g. laser, massage or other local intervention) for their scar in the three months prior to the data collection.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Interdisciplinary Network Complementary & Alternative Medicine Research: collaborator
• Société Européenne de Recherche en Ostéopathie Pédiatrique et Périnatale (SEROPP): collaborator

Study Sites (4)

Clinique d'ostéopathie et de massothérapeie FDL

Candiac, Quebec, J5R 4R5, Canada

Location

ENOSI centre d'ostéopathie

Montreal, Quebec, H3N 1W7, Canada

Location

Clinide d'ostéopathie Parent-Aise

Repentigny, Quebec, J5Y 3R2, Canada

Location

AXiO Medecine Clinic

Vaudreuil-Dorion, Quebec, J7V 9R2, Canada

Location

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MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathaly NG Gaudreault, Ph. D, Pt

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: An exploratory descriptive design with before and after measurements.

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 25, 2020
• Study Start: January 9, 2020
• Primary Completion: June 16, 2020
• Study Completion: November 20, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)