Does adding myofascial release (a type of soft tissue manipulation) to silicone patches improve Caesarean scar healing more than using silicone patches alone?
| ISRCTN | ISRCTN10914133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10914133 |
| Secondary identifying numbers | KB/92/FI/2018 |
- Submission date
- 09/12/2019
- Registration date
- 20/12/2019
- Last edited
- 20/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims:
Caesarean sections are increasingly used to deliver babies. In Poland about 40% of deliveries end in a C-section. Caesarean scar healing can require targeted actions to reduce tightness and pulling and separate it from surrounding tissues. Silicone patches have been shown to improve scar healing. This study aims to investigate whether manipulation of the skin and tissues around the scar, similar to massage, can improve healing still further.
Who can participate?
Women aged 18-45 after Caesarean section (within 6-12 weeks after the delivery)
What does the study involve?
Participants will be randomly allocated into one of two groups. Both groups will use silicone patches on the Caesarean scar. One group will also receive manual therapy treatment from a therapist once a week for 8 weeks and be shown how to repeat the treatment themselves at home. The scar and associated pain will be assessed before treatment, 1 month after treatment and 6 months after treatment.
What are the possible benefits and risks of participating?
Participants might benefit from learning more about their scar and how to encourage it to heal. They will all receive treatment that has been shown to improve scar healing. There are no side effects of the planned treatment.
Where is the study run from?
Opole Medical School (Poland)
When is the study starting and how long is it expected to run for?
October 2018 to April 2022
Who is funding the study?
Opole Medical School (Poland)
Who is the main contact?
Dr Lucyna Ptaszkowska, ptaszkowska.l@gmail.com
Contact information
Scientific
Opole Medical School
Katowicka 68
45-060 Opole
Opole
45-060
Poland
 ORCID ID |
0000-0002-7706-0971 |
|---|---|
| Phone | +48 695401515 |
| ptaszkowska.l@gmail.com |
Public
Opole Medical School
Katowicka 69
Opole
45-060
Poland
| ORCID ID |
0000-0002-5642-6436 |
|---|---|
| Phone | +48 506174008 |
| pasmal@wp.pl |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
| Scientific title | The effect of selected therapeutic (myofascial relaxation techniques and silicone patches) interventions on the biomechanical properties of scar tissue after Caesarean section |
| Study hypothesis | 1. Assessment of biomechanical properties of scar tissue within the scar after Caesarean section depending on the therapeutic intervention used (myofascial release techniques and silicone patches). 2. Assessment of improvements in Vancouver Scar Scale (VSS) and pain reduction (VAS). |
| Ethics approval(s) | Approved 25/10/2018, Opole Medical School Bioethics Commission (Katowicka 68, 45-060 Opole, Poland; +48 774410882; sekprorek.ds.nauk@wsm.opole.pl), ref: KB/92/FI/2018 |
| Condition | Scarring after Caesarean section |
| Intervention | Participants will be randomly assigned to one of two comparison groups. Randomization using a 1:1 randomization scheme will be carried out using computer-generated random numbers (simple randomization). The therapy programme lasts 8 weeks during which all the participants receive the silicone patches to promote scar healing. In addition, women assigned to one of the groups will undergo manual therapy treatment consisting of 8 meetings with a qualified physiotherapist (once a week). They will also repeat the manual techniques themselves at home. The manual scar therapy procedure based on myofascial relaxation techniques consists of techniques such as: 1. Overall stretching technique - 5 min 2. Technique of delicate circles - 5 min 3. Up and down stretching movements in the shape of the letter J - 5 min 4. Vertical lifting technique - 5 min 5. Skin rolling - 5 min 6. S-shaped technique - 5 min All participants will undergo assessment of the biomechanical properties of the scar area before the start of treatment, 1 month after and 6 months after the therapy programme. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Scar tissue tone assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention 2. Scar tissue stiffness assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention 3. Scar tissue elasticity assessed using the MyotonPRO digital palpation device before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention |
| Secondary outcome measures | 1. Scar severity (comprising vascularity, height/thickness, pliability, and pigmentation) assessed using the Vancouver Scar Scale before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention 2. Scar pain assessed using a visual analogue scale (VAS) before the start of the intervention, immediate after the end of the intervention and 1 month and 6 months after the end of the intervention |
| Overall study start date | 01/10/2018 |
| Overall study end date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Women after Caesarean section within 6 weeks of surgery (transverse cut using the Pfannenstiel method) 2. Full healing of the wound after the scab falls off 3. Healthy on the day of the test 4. End of the puerperium period 5. Aged 18-45 years |
| Participant exclusion criteria | 1. Caesarean section was less than 6 weeks or more than 12 weeks previously 2. Incomplete wound healing (exudate, local inflammation) 3. Malaise on the day of the test 4. Caesarean section in multiple pregnancies 5. Lack of consent of the examined person |
| Recruitment start date | 15/01/2020 |
| Recruitment end date | 30/09/2021 |
Locations
Countries of recruitment
- Poland
Study participating centre
Opole
45-060
Poland
Sponsor information
University/education
Katowicka 68
Opole
45-060
Poland
| Phone | +48 (0)774423546 |
|---|---|
| snw@wsm.opole.pl | |
| Website | http://wsm.opole.pl/1/strona-glowna.html |
"ROR" |
https://ror.org/000bjk220 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned for publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
13/12/2019: Trial's existence confirmed by Opole Medical School Bioethics Commission.
