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Cesarean BirthNCT07897253

Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery

A study testing Direct scar massage and Indirect massage group in people with Cesarean Birth and Massage, run by Concordia University, Montreal at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cesarean section is the most common inpatient surgical procedure worldwide, with rates continuing to rise; in Canada, approximately one in three births occur by cesarean. Despite its prevalence, there are no expectations for individuals who have undergone a cesarean section to seek out rehabilitation care. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cesarean Birth, Massage, Rehabilitation
What is being tested?
Direct scar massage and Indirect massage group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
8 May 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Have had 1 or more cesarean births.
  • Have had a cesarean birth, and within the past 6 months.
  • Minimum 5-weeks postpartum (to start the study), with a fully healed incision.
  • No history of wound complications during initial healing (e.g., wound opening, fluid collection, or surgical site infection).
  • Presence of pain or unpleasant sensations associated with the cesarean scar (e.g., hypersensitivity, pulling, tightness, or lower back pain) that were not present prior to surgery. The pain could be intermittent, at rest or with activity.
  • o Numeric Pain Rating Scale (NPRS) will be used here. The potential participant will be instructed to rate their highest level of pain on a scale of 0-10 at some point in the month prior to this eligibility screening. This rating must be a minimum 3/10. If they are less than a 3/10 on the NPRS they will be excluded.
  • No previous or current scar therapy following the most current cesarean birth.

Who cannot join

  • History of cancer.
  • Presence of an active infection.
  • Regular use of analgesic medication specifically for cesarean scar-related pain.
  • Currently pregnant, actively undergoing fertility treatment, or planning pregnancy during the study intervention period.
  • History of radiation therapy to the abdominal area.
  • Known connective tissue disorders affecting tissue healing (e.g., Ehlers-Danlos syndrome).
  • Uncontrolled diabetes or other endocrine disorders.
  • Neurological conditions affecting sensation (e.g., peripheral neuropathy or central nervous system disorders).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Concordia University- RICHARD J. RENAUD SCIENCE COMPLEX (SP Building)

    Montreal, Quebec, H4B1R6

    Andreas Bergdahl, PhD, 514-848-2424 ext. 3372, andreas.bergdahl@concordia.ca

    Jacqueline Camley

    Recruiting

Other trials in Canada

About this study

Official title: Effects of Rehabilitation on Scar Tissue Characteristics and Functional Recovery Following Cesarean Birth

Cesarean section is the most common inpatient surgical procedure worldwide, with rates continuing to rise; in Canada, approximately one in three births occur by cesarean. Despite its prevalence, there are no expectations for individuals who have undergone a cesarean section to seek out rehabilitation care. Physical recovery guidance and return to activity from a cesarean birth is poorly understood and inadequately supported, with most research focusing on immediate post-operative pain management within the hospital settings. Little attention has been given to long term physical recovery.

Scar-related problems - such as tight or stuck scar tissue, sensitivity or discomfort around the scar, weakness in the abdominal muscles, and infertility or digestive complications - can severely affects the ability to complete daily activities and affect overall quality of life. Rehabilitation is a common and important part of recovery after most major orthopedic and abdominal surgeries. It can help reduce pain and complications, improve mobility, strength, and confidence in movement, and support a gradual return to physical activity. Just as importantly, rehabilitation helps individuals safely resume everyday responsibilities such as caring for their family, returning to work, and managing daily tasks.

Read more

The purpose of this study is to examine whether one form of hands-on therapy results in greater improvements in scar comfort, mobility, and performance of daily activities compared with an alternative approach, when both are delivered alongside an identical exercise program.

Participants will take part in an 8-week rehabilitation program following cesarean birth. Rehabilitation will be provided one-on-one by a qualified healthcare professional and will include a combination of in-person sessions and virtual (online) check-ins. In-person sessions will include education about recovery, hands-on therapy, and guided exercises. Virtual sessions will be used to answer questions, review progress, and ensure that exercises are being performed safely and correctly at home.

To evaluate changes in recovery over time, participants will attend three assessment sessions: at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8). During these sessions, researchers will collect information on:

  • How the scar looks and moves
  • The sensitivity or discomfort of the scar area
  • How easily participants can perform everyday movements, such as standing up from a chair
  • How participants feel about their scar, pain levels, and daily function There will be two forms off assessments. One that measures the objective changes: photographs of the scar, gentle pressure testing to measure sensitivity, simple movement tests, and ultrasound imaging, while the other form of assessment is patient reported questionnaires about how they feel they are improving. Ultrasound is a safe and painless technique that allows researchers to see how tissues under the skin are healing and moving.

The anticipated benefit of this research is to improve understanding of physical recovery after cesarean birth. The results may help inform future rehabilitation recommendations and contribute to better support for individuals recovering from cesarean surgery.

Being tested
Direct scar massage, Indirect massage group
Keywords
cesarean birth, rehabilitation, scar massage, exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct scar massageOther

    This group will complete an 8 week hybrid model (in person and online alternative) rehabilitation program. In person sessions involve 30 minutes of massage on neck, pectoral and lower back, and four exercises. The direct scar massage technique group will be introduced to a new direct scar massage technique every 2 weeks. These techniques will be self administered daily for 5 minutes. The techniques will progress from circular motions, direct specific work, bend and torque and lifting techniques.

  • Indirect massage groupOther

    This group will receive the exact same hybrid model, 30 minute massage and exercises, however their 5 minute self administered at home portion will involve static stretches of the pectorals, neck and trigger point release of the lumbar spine.

Study groups in NCT07897253
Study groupRoleWhat they receive
Indirect massageActive comparatorThe control group will complete the same hybrid model rehabilitation program with in person and online sessions, 30 minutes of massage to the neck, pectorals and lower back during in person sessions, and four exercises. However, they will not complete 5 minutes of direct scar massage on the cesarean scar.
Receives: Other: Indirect massage group
Direct scar massage groupExperimentalThe participants in the direct scar massage group will be expected to complete 5 minutes of self administered scar massage daily at home.
Receives: Other: Direct scar massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scar Pressure Pain Threshold Measured Using a Digital Pressure Algometer (Newtons)

    Scar pressure pain threshold will be assessed using a digital pressure algometer to quantify the force applied at the point when the participant first perceives pressure as painful. Measurements will be taken twice at each of five standardized points along the cesarean scar. Force will be recorded in Newtons (N). The mean pressure pain threshold across the two measurements at each site will be recorded, and then the total mean pressure threshold for all 5 sites together will be calculated for analysis. If appropriate, site-specific values and, the mean across the five measurement sites will be reported. This is a non-invasive assessment. Pressure pain threshold was selected as an objective measure of scar sensitivity because reducing scar-related sensitivity is an anticipated effect of the scar-focused rehabilitation intervention.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  2. Cesarean Scar Mobility Measured Using a Modified Adherometer (mm²)

    Scar mobility will be assessed using a modified adherometer at five standardized points along the cesarean scar. Displacement will be measured in millimeters (mm) in three directions: upward, leftward, and rightward. Surface mobility (SM) will be calculated in square millimeters (mm²) using the prespecified method (SM=((left + right) x (up)/2) for combining measurements across directions. The mean SM will then be calculated by averaging the SM values obtained at the five standardized points, yielding one overall SM value per participant. If appropriate, site-specific values at each of the five measurement sites will be reported. Higher values indicate greater scar mobility. Scar mobility was selected as an objective measure of tissue restriction because improving scar and surrounding tissue mobility is a targeted effect of the scar-focused rehabilitation intervention.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  3. SCAR-Q Questionnaire Scores for Scar Appearance, Symptoms, and Psychosocial Impact (0-100)

    Scar-related patient-reported outcomes will be assessed using the SCAR-Q questionnaire. Scores will be calculated separately for the applicable domains of scar appearance, symptoms, and psychosocial impact according to the instrument's scoring guidelines. Raw responses will be converted to Rasch-transformed scores ranging from 0 to 100, with higher scores indicating better outcomes. Changes in domain scores from baseline will be evaluated over the study period. The SCAR-Q was selected as a validated patient-reported outcome measure to capture the participant's perception of scar appearance, symptoms, and psychosocial impact, providing a complementary assessment of clinically relevant scar-related outcomes not captured by objective measures of scar mobility and sensitivity.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  4. Pelvic Girdle Pain-Related Disability Score Measured Using the Pelvic Girdle Pain Questionnaire (0-100)

    Pelvic girdle pain-related symptoms and activity limitations will be assessed using the Pelvic Girdle Pain Questionnaire. The questionnaire score will be calculated and converted to a percentage (sum of scores/75*100) according to the instrument's validated scoring instructions, with scores ranging from 0 to 100. Higher scores indicate greater symptom burden and disability, while lower scores indicate fewer symptoms and less disability. Changes in scores from baseline will be evaluated over the study period. The PGQ was selected as a validated measure of pelvic girdle pain-related symptoms and functional limitations because reducing pain-related disability and improving physical function are anticipated effects of the rehabilitation intervention.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

Secondary outcomes (8)
  1. Number of Sit-to-Stand Repetitions Completed in 30 Seconds

    Lower-body functional performance will be assessed using the 30-Second Sit-to-Stand Test. The number of correctly completed sit-to-stand repetitions within 30 seconds will be recorded. A higher number of repetitions indicates greater functional capacity. Changes in the number of repetitions from baseline will be evaluated over the study period.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  2. Patient-Specific Functional Scale Mean Activity Score (0-10)

    Activity-related functional limitations will be assessed using the Patient-Specific Functional Scale. Each participant will identify three activities that are important to them and that have become difficult following cesarean birth. Each activity will be rated on a scale from 0 (unable to perform the activity) to 10 (able to perform the activity at the pre-problem level). The mean score will be calculated by summing the three activity ratings and dividing by the number of activities rated. Higher scores indicate better self-reported functional ability. Changes in the mean score from baseline will be evaluated over the study period.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  3. Dynamic Tissue Displacement Measured Using Diagnostic Ultrasound

    Dynamic ultrasound videos will be obtained at five standardized points along the scar, with the transducer positioned vertically, while participants perform a deep inspiration. Tissue displacement relative to adjacent tissue layers will be measured to assess tissue sliding. A displacement of <1 cm or more will be classified as a negative sliding sign, indicating restricted tissue mobility potentially consistent with adhesions; a displacement of 1 cm or greater will be classified as a positive sliding sign. Continuous measurements of tissue displacement and the proportion of sites classified as having a positive sliding sign will be reported. Changes in ultrasound-derived measurements from baseline will be evaluated over the study period.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  4. Cesarean Scar Thickness Measured Using Diagnostic Ultrasound

    Diagnostic ultrasound will be used to assess cesarean scar thickness. Static ultrasound images will be obtained at three standardized points along the length of the cesarean scar, with the transducer positioned horizontally. Scar thickness will be measured in millimeters (mm) using Digital Imaging and Communications in Medicine (DICOM) imaging software. The mean scar thickness across the three standardized measurement points will be calculated, with higher values indicating greater scar thickness. Changes in ultrasound-derived measurements from baseline will be evaluated over the study period.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  5. Tissue Echogenicity Measured Using Diagnostic Ultrasound

    Diagnostic ultrasound will be used to assess cesarean scar tissue echogenicity. Static ultrasound images will be obtained at three standardized points along the length of the cesarean scar, with the transducer positioned horizontally. Echogenicity will be quantified using grayscale analysis within a standardized region of interest (ROI) encompassing the scar tissue. Mean pixel intensity will be calculated on a grayscale ranging from 0 (black) to 255 (white), with higher values indicating greater tissue echogenicity. The echogenity across the three standarized measurement points will be reported for each participant. If appropriate, the mean echogenicity across the three standardized measurement points will be calculated to provide a single value for each participant.

    Measured: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)

  6. Participant-Reported Feasibility and Acceptability of the Hybrid Postpartum Rehabilitation Program

    At the end of the intervention, participants will complete a study-specific feasibility questionnaire containing Likert-scale items and open-ended questions. The questionnaire will assess participant perceptions of the hybrid rehabilitation model, including the combination of online and in-person sessions, the number and target areas of the prescribed exercises, and the acceptability of self-administered scar release and massage. Responses to Likert-scale items will be summarized descriptively, and open-ended responses will be analyzed thematically. No single composite score will be calculated unless a scoring method has been prespecified.

    Measured: Questionnaire completed at end point testing (week 8)

  7. Study Retention rate

    Retention feasibility will be assessed by documenting the number of participants who complete the study relative to the number enrolled. The retention rate will be calculated as the number of participants who complete the study divided by the number of participants enrolled, expressed as a percentage: Retention rate (%) = (Number of participants who complete the study / Number of participants enrolled) × 100

    Measured: Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year.

  8. Study Feasibility of Recruitment

    Recruitment feasibility will be assessed by documenting the number of individuals who complete the study eligibility screening form, the number and proportion who are determined to be eligible or ineligible, and the number of eligible individuals who enroll in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the number of individuals determined to be eligible, expressed as a percentage: Recruitment rate (%) = (Number enrolled / Number eligible) × 100

    Measured: Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start8 May 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897253
Sponsor's protocol ID
30023344
Status last verified
Aug 2026
First submitted
4 Sep 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Direct scar massage and Indirect massage group in people with Cesarean Birth and Massage, run by Concordia University, Montreal at 1 site in Canada.

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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andreas Bergdahl, PhD (514-848-2424 ext. 3372, andreas.bergdahl@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scar Pressure Pain Threshold Measured Using a Digital Pressure Algometer (Newtons) (time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Oct 2026.

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