An interventional study of Direct scar massage and Indirect massage group in Cesarean Birth, Massage and Rehabilitation, sponsored by Concordia University, Montreal. Recruiting at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Concordia University, Montreal · Not applicable, Interventional, and Treatment
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.
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:
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.
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Presence of pain or unpleasant sensations associated with the cesarean scar (e.g., , 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Other: Indirect massage group
The participants in the direct scar massage group will be expected to complete 5 minutes of self administered scar massage daily at home.
Other: Direct scar massage
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.
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.
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8)
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.
Time frame: Questionnaire completed at end point testing (week 8)
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
Time frame: Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year.
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
Time frame: Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year.
Plan to share: No
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Concordia University, Montreal