Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar

November 19, 2024 updated by: Riphah International University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 3800
        • Kulsoom Shoukat Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Scar Mobilization:
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:
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
Active Comparator: Myofascial Cupping Therapy
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:
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: up to 4 weeks
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)
Time Frame: up to 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kainat Ashfaq, MS*, Riphah International University, Lahore, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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