Cesarean Section; Complications, Wound, HematomaNCT06339983
Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar
A study testing Manual Scar Mobilization Therapy: and Myofascial Cupping Therapy: in people with Cesarean Section; Complications, Wound, Hematoma, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Complications, Wound, Hematoma
- What is being tested?
- Manual Scar Mobilization Therapy: and Myofascial Cupping Therapy:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 5 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diabetic women
- Skin irritation or infection at the scar site
- Women with Diastasis Recti Abdominis
- Obese women (BMI<35%)
- Women with Hysterectomy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Kulsoom Shoukat Medical Complex
Faisalābad, Punjab Province, 3800
About this study
Official title: 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.
Read the 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.
- Being tested
- Manual Scar Mobilization Therapy:, Myofascial Cupping Therapy:
- Keywords
- Cesarean Scar, Mobilization, Manual therapy
- Medical subject headings
- Wounds and Injuries, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Myofascial Cupping Therapy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; Complications, Wound, HematomaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kainat Ashfaq, MS*, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339983
- Sponsor's protocol ID
- REC/RCR & AHS/23/0566
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30701520Singh 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.
PubMed 33376704Vejnovic TR. [Cesarean delivery--Vejnovic modification]. Srp Arh Celok Lek. 2008 May;136 Suppl 2:109-15. doi: 10.2298/sarh08s2109v. Serbian.
PubMed 18924480Olszewska 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.
PubMed 37665082Gilbert 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.
PubMed 35426735Lubczynska 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.
PubMed 36973982Pianese 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.
PubMed 36059328
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Scar Mobilization Versus Myofascial Cupping Technique on Pain, Physical Characteristics, and Appearance of the Cesarean Scar
- ClinicalTrials.gov ID
- NCT06339983
- Acronym / sponsor ID
- REC/RCR & AHS/23/0566
- Keywords
- Cesarean Scar, Mobilization, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Scar Mobilization: | Experimental | Other: Manual Scar Mobilization Therapy: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. |
| Myofascial Cupping Therapy | Active comparator | Other: 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Diabetic women
- Skin irritation or infection at the scar site
- Women with Diastasis Recti Abdominis
- Obese women (BMI<35%)
- Women with Hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Manual Scar Mobilization: |
| 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 | Other | Myofascial Cupping Therapy |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 30701520Abbas 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.
- Background: PubMed 33376704Singh 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.
- Background: PubMed 18924480Vejnovic TR. [Cesarean delivery--Vejnovic modification]. Srp Arh Celok Lek. 2008 May;136 Suppl 2:109-15. doi: 10.2298/sarh08s2109v. Serbian.
- Background: PubMed 37665082Olszewska 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.
- Background: PubMed 35426735Gilbert 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.
- Background: PubMed 36973982Lubczynska 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.
- Background: PubMed 36059328Pianese 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kainat Ashfaq, MS* principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Scar Mobilization Therapy: and Myofascial Cupping Therapy: in people with Cesarean Section; Complications, Wound, Hematoma, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339983, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.