UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060718 |
|---|---|
| Receipt number | R000069466 |
| Scientific Title | Tele-Supervised Cesarean Scar Massage: Effects on Pain, Tactile Sensation, Functional Outcomes, and Tissue Healing: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/02/20 20:21:27 |
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Basic information
Public title
The effect of scar tissue massage on pain, tactile sensation, tissue healing, scar quality, and functional status after cesarean section surgery
Acronym
The effect of scar tissue after cesarean section surgery
Scientific Title
Tele-Supervised Cesarean Scar Massage: Effects on Pain, Tactile Sensation, Functional Outcomes, and Tissue Healing: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Tele-Supervised Cesarean Scar Massage
Region
| Asia(except Japan) |
Condition
Condition
Rehabilitation
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of physiotherapist-guided, tele-supervised, self-administered cesarean scar massage on scar quality, pain, tactile sensory function, functional status, and tissue healing during the early postpartum period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area, as well as patient-reported symptoms such as pain and itching. Pain was assessed using pressure pain threshold measurements and the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire. Pressure pain threshold was measured using a digital pressure algometer (J-TECH USA Commander), with pressure applied perpendicular to the scar area.
Key secondary outcomes
Tactile sensory function was assessed using Semmes Weinstein monofilaments applied perpendicular to the skin over the scar and periscar regions until bending occurred. Two-point discrimination was assessed using an esthesiometer, and the minimum distance at which two distinct points were perceived was recorded. Lower values indicate improved sensory discrimination and neural function. Functional disability related to daily activities was assessed using the Oswestry Disability Index (ODI). Infrared thermographic imaging was performed using a thermal camera under standardized environmental conditions, including controlled room temperature, humidity, and participant acclimatization before measurement.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants assigned to the intervention group received structured scar massage training delivered by a physiotherapist during an initial face-to-face session. During this session, participants were educated about scar tissue characteristics, and scar massage techniques were demonstrated directly on the cesarean scar and surrounding tissues. The scar massage protocol included superficial and deeper tissue mobilization techniques, consisting of circular, longitudinal, and transverse movements applied to the scar and periscar regions.
Interventions/Control_2
Participants in the control group did not receive scar massage training or any manual therapy intervention. They were provided only with standardized daily living activity recommendations, including advice on safe bed mobility, avoidance of excessive strain on the incision site during reaching, coughing, sneezing, or lifting, maintaining proper ergonomics during breastfeeding and infant care, avoiding heavy lifting and sudden bending movements, refraining from strenuous exercise, and engaging in light walking to support recovery, prevent constipation, and reduce the risk of thromboembolic complications.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
Inclusion criteria were women aged 18 35 years, singleton pregnancy delivered by primary cesarean section, gestational age more 34 weeks, and being at the 6th postoperative week at the time of baseline assessment.
Key exclusion criteria
Exclusion criteria included a history of previous abdominal or pelvic surgery, postoperative wound complications (infection, dehiscence, or hematoma), diagnosed neurological or rheumatological disorders, systemic diseases known to affect wound healing (e.g., diabetes mellitus), use of analgesic or anti-inflammatory medication that could influence pain perception during the study period, and inability to participate in tele-supervised follow-up sessions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent university
Division name
Department of Physiotherapy and Rehabilitation
Zip code
06790
Address
Baskent University, Health Sicence Faculty, Department of Physiotherapy and Rehabilitation
TEL
+905392699266
acarmanolya@hotmail.com
Public contact
Name of contact person
| 1st name | Manolya |
| Middle name | |
| Last name | acar |
Organization
Baskent University
Division name
Department of Physiotherapy and Rehabilitation
Zip code
06790
Address
Baskent University, Health Sicence Faculty, Department of Physiotherapy and Rehabilitation
TEL
+905392699266
Homepage URL
acarmanolya@hotmail.com
Sponsor or person
Institute
No Sponsor
Institute
Department
Personal name
Funding Source
Organization
No Funding Source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Baskent University
Address
Baskent University, Health Sicence Faculty, Department of Physiotherapy and Rehabilitation
Tel
+905392699266
acarmanolya@hotmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069466
