Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar

NCT06339983 | Completed

• 1 other identifier: REC/RCR & AHS/23/0566
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Complications, Wound, Hematoma

Keywords

Cesarean Scar; Mobilization; Manual therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Manual Scar Mobilization:

EXPERIMENTAL

Group will undergo 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 which will be followed by skin rolling. The manual therapy will include different techniques such as rolling, stroking, superficial rubbing, deep rubbing, breaking up, and pinching. The therapy will continue for 15 minutes.

Other: Manual Scar Mobilization Therapy:

Myofascial Cupping Therapy

ACTIVE COMPARATOR

Group will receive myofascial cupping therapy. In this method, the patient will lie down on the bed with an exposed scar area. Application areas will be cleaned and herbal oil or cream will be applied. 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 for approximately 5-15 minutes. Then the cup will be removed gently. After this, the application areas will be cleaned.

Other: Myofascial Cupping Therapy:

Interventions

Manual Scar Mobilization Therapy: OTHER

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

Manual Scar Mobilization:

Myofascial Cupping Therapy: OTHER

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

Myofascial Cupping Therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Kulsoom Shoukat Medical Complex

Faisalābad, Punjab Province, 3800, Pakistan

Location

Related 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.

  PMID: 30701520 BACKGROUND

• 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.

  PMID: 33376704 BACKGROUND

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

  PMID: 18924480 BACKGROUND

• 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.

  PMID: 37665082 BACKGROUND

• 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.

  PMID: 35426735 BACKGROUND

• 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.

  PMID: 36973982 BACKGROUND

• 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.

  PMID: 36059328 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Hematoma

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kainat Ashfaq, MS*

  Riphah International University, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: September 20, 2024
• Study Completion: October 5, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)