Clinical trial NCT06339983: Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar
Official title: Comparative Effects of Manual Scar Mobilization Versus Myofascial Cupping Technique on Pain, Physical Characteristics, and Appearance of the Cesarean Scar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Complications, Wound, Hematoma
Keywords: Cesarean Scar
Mobilization
Manual therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: up to 4 weeks
measure: Manchester Scar Scale (MSS)
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Kulsoom Shoukat Medical Complex
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Kainat Ashfaq, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Vejnovic TR. [Cesarean delivery--Vejnovic modification]. Srp Arh Celok Lek. 2008 May;136 Suppl 2:109-15. doi: 10.2298/sarh08s2109v. Serbian.
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. 2024 Apr;33(4):387-395. doi: 10.17219/acem/169236.
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.
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.
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.