Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar

Cesarean Section; Complications, Wound, Hematoma Clinical Trial

Official title:

Comparative Effects of Manual Scar Mobilization Versus Myofascial Cupping Technique on Pain, Physical Characteristics, and Appearance of the Cesarean Scar

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06339983
• Other study ID #: REC/RCR & AHS/23/0566
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 5, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Ghulam Fatima, PhD*
• Phone: 03034073057
• Email: ghulam.fatima[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29.

Description:

A cesarean is a surgical procedure used to deliver a baby through an incision in the mother's abdomen and uterus. Manual scar mobilization and myofascial cupping techniques are some of the beneficial techniques to treat the scar. The research aims to understand the comparative effects of both techniques to know the potential benefits of these techniques on the outcome of pain, physical characteristics, and appearance of the cesarean scar. This study contributes valuable insights into comparing tailored interventions for improving the cesarean scar. This will be a randomized clinical trial conducted on 52 participants. Data will be collected from KulsoomShoukat Medical Complex, Faisalabad by using a non-probability convenience sampling technique. Primigravida women aged from 20 to 40 who have 6 months post cesarean completely healed but painful scars and who haven't undergone any scar therapy before will be included in the study. On the contrary, participants with any previous scar therapy or having infectious scars will be excluded from the study. A sample of 48 will be divided into 2 groups through random allocation. Group A will undergo manual scar mobilization therapy for 15 minutes on a cesarean scar twice a week. Group B will receive myofascial cupping therapy for 15 minutes twice a week. Treatment in both groups will be given for 4 weeks and pain will be assessed before 4 weeks and then after 4 weeks by a numeric pain rating scale (NPRS). Physical characteristics and appearance will be assessed by the Manchester Scar Scale for cesarean scar (MSS) in both groups pre and post-intervention. Data will be analyzed using SPSS version 29.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 5, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with Pfannenstiel Cesarean section scar
• Primigravida
• Women who didn't undergo any scar therapy
• The age of the scar should be under 6 months
• Women with a completely healed scar
• Women with painful scar

Exclusion Criteria:

• Diabetic women
• Skin irritation or infection at the scar site
• Women with Diastasis Recti Abdominis
• Obese women (BMI<35%)
• Women with Hysterectomy

Related Conditions & MeSH terms

• Cesarean Section; Complications, Wound, Hematoma
• Hematoma

Intervention

Other:
• Manual Scar Mobilization Therapy:
In this therapy, deep pressure on some point of the area of the scar will be given which will be perpendicular to the skin and will be followed by skin rolling
• Myofascial Cupping Therapy:
A disposable plastic cup (5cm) will be positioned at THE selected area of the cesarean scar. Then, negative pressure will be applied using a mechanical vacuum pump, the cup will be gently slid around the selected area rhythmically to get a massage-like effect

Locations

Country	Name	City	State
Pakistan	Kulsoom Shoukat Medical Complex	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Abbas F, Ud Din RA, Sadiq M. Prevalence and determinants of Caesarean delivery in Punjab, Pakistan. East Mediterr Health J. 2019 Jan 23;24(11):1058-1065. doi: 10.26719/2018.24.11.1058. — View Citation

Gilbert I, Gaudreault N, Gaboury I. Exploring the Effects of Standardized Soft Tissue Mobilization on the Viscoelastic Properties, Pressure Pain Thresholds, and Tactile Pressure Thresholds of the Cesarean Section Scar. J Integr Complement Med. 2022 Apr;28(4):355-362. doi: 10.1089/jicm.2021.0178. Epub 2022 Jan 13. — View Citation

Lubczynska A, Garncarczyk A, Wcislo-Dziadecka D. Effectiveness of various methods of manual scar therapy. Skin Res Technol. 2023 Mar;29(3):e13272. doi: 10.1111/srt.13272. — View Citation

Olszewska K, Ptak A, Rusak A, Debiec-Bak A, Stefanska M. Changes in the scar tissue structure after cesarean section as a result of manual therapy. Adv Clin Exp Med. 2023 Sep 4. doi: 10.17219/acem/169236. Online ahead of print. — View Citation

Pianese L, Bordoni B. The Use of Instrument-Assisted Soft-Tissue Mobilization for Manual Medicine: Aiding Hand Health in Clinical Practice. Cureus. 2022 Aug 31;14(8):e28623. doi: 10.7759/cureus.28623. eCollection 2022 Aug. — View Citation

Singh N, Pradeep Y, Jauhari S. Indications and Determinants of Cesarean Section: A Cross-Sectional Study. Int J Appl Basic Med Res. 2020 Oct-Dec;10(4):280-285. doi: 10.4103/ijabmr.IJABMR_3_20. Epub 2020 Oct 7. — View Citation

Vejnovic TR. [Cesarean delivery--Vejnovic modification]. Srp Arh Celok Lek. 2008 May;136 Suppl 2:109-15. doi: 10.2298/sarh08s2109v. Serbian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.	up to 4 weeks
Primary	Manchester Scar Scale (MSS)	In 1998 Beausang et al proposed a scale to assess scars which is the Manchester Scar Scale (MSS). It rates the different physical characteristics of scar which are contour to surrounding skin (range from flush to keloid) and texture (range normal to hard). Scores from the parameters are then all together to get the total score, with higher scores representing clinically worse scars. Manchester scar scale also gives the appearance of the scar that is color (from perfect to mismatched), relationship with the surrounding skin (shiny or mate), and distortion (none to severe). Then the score is added to get the overall opinion about the scar.	up to 4 weeks