Scar TissueNCT05355181
Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain
A study testing Scar mobilization techniques and Core stabilization exercises in people with Scar Tissue and Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Scar Tissue, Back Pain
- What is being tested?
- Scar mobilization techniques and Core stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2022to 30 Nov 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 -40 years.
- Lower segment transverse incision technique used.
- Minimum 6 weeks postnatal.
- Completely healed Scar.
- Limited scar mobilization in any direction or lifting.
- No complications after the surgery.
Who cannot join
- Women with an abdominal hernia.
- Multiple births.
- Skin irritation or infection at the scar site.
- Diastasis Recti Abdominis
- History of abdominal surgery other than cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Scar Mobilization Techniques With and Without Core Stability Exercises on Scar Tissue Mobility and Lumbopelvic Pain Following Cesarean Section
The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Duration of study will 6 months, convenient sampling technique used, subject following eligibility criteria from Rafiqa Medical Centre, Sargodha and Fatima Hospital, Sargodha, will randomly be allocated in two groups via lottery method, baseline assessment will be done, Group A participants will be given baseline treatment along with scar mobilization and core stabilization exercises, Group B participants will be given baseline treatment along with scar mobilization for 3 weeks. On the 5th and 9th day, the post-intervention assessment will be done via, Manual Scar mobility testing, Vancouver Scar Scale, Numeric Pain Rating Scale, and Oswestry Disability Index. 3 sessions per week will be given.
Read the detailed description
The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Duration of study will 6 months, convenient sampling technique used, subject following eligibility criteria from Rafiqa Medical Centre, Sargodha and Fatima Hospital, Sargodha, will randomly be allocated in two groups via lottery method, baseline assessment will be done, Group A participants will be given baseline treatment along with scar mobilization and core stabilization exercises, Group B participants will be given baseline treatment along with scar mobilization for 3 weeks. On the 5th and 9th day, the post-intervention assessment will be done via, Manual Scar mobility testing, Vancouver Scar Scale, Numeric Pain Rating Scale, and Oswestry Disability Index. 3 sessions per week will be given.
Scar mobilization techniques include the gentle stroking and lifting of the scar as well as moving the scar tissue in different directions. It also includes rolling, C- grip, S-grip, and ram horn mobilization of the scar tissue. These techniques are helpful to the physiotherapists to effectively remove the negative effects of poor wound healing, restore the aesthetics of visible tissues and hence improve the functioning of the fascial network, and thus also other parts of the body.
Core stabilization exercises administered to the patients after cesarean section include the posture corrective exercises, abdominal draw-in, squatting, pelvis tilting, knee to chest, flexibility, and stretching exercises and bridges.
Breathing exercises, isometric, and general mobility exercises were incorporated as baseline exercises in both groups.
- Conditions
- Scar Tissue, Back Pain
- Being tested
- Scar mobilization techniques, Core stabilization exercises
- Keywords
- Cicatrix, Pelvic Girdle Pain, Postpartum Period, scar, back pain
- Medical subject headings
- Cicatrix, Back Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar mobilization techniquesOther
Scar mobilization techniques include the gentle stroking and lifting of the scar as well as moving the scar tissue in different directions. It also includes rolling, C- grip, S-grip, and ram horn mobilization of the scar tissue.
Core stabilization exercises administered after cesarean section include the posture corrective exercises, abdominal draw-in, squatting, pelvis tilting, knee to chest, flexibility and stretching exercises, and bridges.
Core stabilization exercisesOther
Core stabilization exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A: scar mobilization and core stabilization exercises group | Experimental | Group A will perform exercises for 3 weeks. Participants will perform core stabilization exercises as well as scar mobility exercises. All exercises will be performed in 3 sessions per week for a period of 3 weeks. Receives: Other: Scar mobilization techniques; Other: Core stabilization exercises |
| Group B: scar mobilization techniques group | Active comparator | Group B will perform scar mobilization exercises for 3 weeks along with baseline treatment.
All exercises will be performed in 3 sessions per week for a period of 3 weeks. Receives: Other: Scar mobilization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Scar mobility testing
The physiotherapist evaluates the appearance and mobility of a healed scar. Mobility is checked by placing the hand or fingertips on or around it. By moving the scar in different directions, the skin's displacement in relation to the fascia is checked. Apart from the free movement of the scar in all directions in the frontal plane, lifting should also be possible.
Measured: up to 3 weeks
Vancouver Scar Scale
The VSS evaluates only 4 physical scar features-pigmentation, vascularity, pliability, and height-and the rater assigns an ordinal value for each feature Each feature has word descriptions for all possible options to help the rater assign a proper value. The values translate into numeric scores, which are then summed into an overall score ranging from 0 to 13 points.
Measured: up to 3 weeks
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 3 weeks
Oswestry Disability Index
The Oswestry Disability Index is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start20 Apr 2022
- Primary completion30 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Scar TissueStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghulam Fatima, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355181
- Sponsor's protocol ID
- REC/Lhr/22/0504 Anam
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
PubMed 28167179Daniszewska-Jarząb I. Manual scar therapy on the example of a caesarean section scar.
Ghavipanje V, Rahimi NM, Akhlaghi F. Six Weeks Effects of Dynamic Neuromuscular Stabilization (DNS) Training in Obese Postpartum Women With Low Back Pain: A Randomized Controlled Trial. Biol Res Nurs. 2022 Jan;24(1):106-114. doi: 10.1177/10998004211044828. Epub 2021 Sep 23.
PubMed 34555964Hui T. Effective Physical Therapy Treatment of Post-Cesarean Section Low Back Pain-Case Report. J Adv Med Med Res. 2017;22:1-5.
Nayyab I, Ghous M, Shakil Ur Rehman S, Yaqoob I. The effects of an exercise programme for core muscle strengthening in patients with low back pain after Caesarian-section: A single blind randomized controlled trial. J Pak Med Assoc. 2021 May;71(5):1319-1325. doi: 10.47391/JPMA.596.
PubMed 34091607Sakamoto A, Nakagawa H, Nakagawa H, Gamada K. Effects of exercises with a pelvic realignment device on low-back and pelvic girdle pain after childbirth: A randomized control study. J Rehabil Med. 2018 Nov 7;50(10):914-919. doi: 10.2340/16501977-2487.
PubMed 30264849Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
PubMed 30282349Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
PubMed 29979205Wasserman JB, Abraham K, Massery M, Chu J, Farrow A, Marcoux BC. Soft tissue mobilization techniques are effective in treating chronic pain following cesarean section: a multicenter randomized clinical trial. Journal of Women's Health Physical Therapy. 2018;42(3):111-9.
Wasserman JB, Copeland M, Upp M, Abraham K. Effect of soft tissue mobilization techniques on adhesion-related pain and function in the abdomen: A systematic review. J Bodyw Mov Ther. 2019 Apr;23(2):262-269. doi: 10.1016/j.jbmt.2018.06.004. Epub 2018 Jun 28.
PubMed 31103106Yalfani A, Bigdeli N, Gandomi F. Effect of isometric-isotonic exercises of core stability in women with postpartum diastasis recti and its secondary disorders (randomized controlled clinical trial). J Health Care. 2020;22:123-37.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scar Mobilization Techniques With and Without Core Stability Exercises on Scar Tissue Mobility and Lumbopelvic Pain Following Cesarean Section
- ClinicalTrials.gov ID
- NCT05355181
- Acronym / sponsor ID
- REC/Lhr/22/0504 Anam
- Conditions
- Scar Tissue, Back Pain
- Keywords
- Cicatrix, Pelvic Girdle Pain, Postpartum Period, scar, back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 May 2022 (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.
The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Duration of study will 6 months, convenient sampling technique used, subject following eligibility criteria from Rafiqa Medical Centre, Sargodha and Fatima Hospital, Sargodha, will randomly be allocated in two groups via lottery method, baseline assessment will be done, Group A participants will be given baseline treatment along with scar mobilization and core stabilization exercises, Group B participants will be given baseline treatment along with scar mobilization for 3 weeks. On the 5th and 9th day, the post-intervention assessment will be done via, Manual Scar mobility testing, Vancouver Scar Scale, Numeric Pain Rating Scale, and Oswestry Disability Index. 3 sessions per week will be given.
Detailed description
The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Duration of study will 6 months, convenient sampling technique used, subject following eligibility criteria from Rafiqa Medical Centre, Sargodha and Fatima Hospital, Sargodha, will randomly be allocated in two groups via lottery method, baseline assessment will be done, Group A participants will be given baseline treatment along with scar mobilization and core stabilization exercises, Group B participants will be given baseline treatment along with scar mobilization for 3 weeks. On the 5th and 9th day, the post-intervention assessment will be done via, Manual Scar mobility testing, Vancouver Scar Scale, Numeric Pain Rating Scale, and Oswestry Disability Index. 3 sessions per week will be given.
Scar mobilization techniques include the gentle stroking and lifting of the scar as well as moving the scar tissue in different directions. It also includes rolling, C- grip, S-grip, and ram horn mobilization of the scar tissue. These techniques are helpful to the physiotherapists to effectively remove the negative effects of poor wound healing, restore the aesthetics of visible tissues and hence improve the functioning of the fascial network, and thus also other parts of the body.
Core stabilization exercises administered to the patients after cesarean section include the posture corrective exercises, abdominal draw-in, squatting, pelvis tilting, knee to chest, flexibility, and stretching exercises and bridges.
Breathing exercises, isometric, and general mobility exercises were incorporated as baseline exercises in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: scar mobilization and core stabilization exercises group | Experimental | Other: Scar mobilization techniques, Other: Core stabilization exercisesGroup A will perform exercises for 3 weeks. Participants will perform core stabilization exercises as well as scar mobility exercises. All exercises will be performed in 3 sessions per week for a period of 3 weeks. |
| Group B: scar mobilization techniques group | Active comparator | Other: Scar mobilization techniquesGroup B will perform scar mobilization exercises for 3 weeks along with baseline treatment. All exercises will be performed in 3 sessions per week for a period of 3 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20 -40 years.
- Lower segment transverse incision technique used.
- Minimum 6 weeks postnatal.
- Completely healed Scar.
- Limited scar mobilization in any direction or lifting.
Key exclusion criteria (5 listed)
- Women with an abdominal hernia.
- Multiple births.
- Skin irritation or infection at the scar site.
- Diastasis Recti Abdominis
- History of abdominal surgery other than cesarean section.
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 |
|---|---|---|
| Scar mobilization techniquesScar mobilization techniques include the gentle stroking and lifting of the scar as well as moving the scar tissue in different directions. It also includes rolling, C- grip, S-grip, and ram horn mobilization of the scar tissue. Core stabilization exercises administered after cesarean section include the posture corrective exercises, abdominal draw-in, squatting, pelvis tilting, knee to chest, flexibility and stretching exercises, and bridges. | Other | Group A: scar mobilization and core stabilization exercises group, Group B: scar mobilization techniques group |
| Core stabilization exercisesCore stabilization exercises | Other | Group A: scar mobilization and core stabilization exercises group |
Primary outcome
Manual Scar mobility testing
Time frame: up to 3 weeks
The physiotherapist evaluates the appearance and mobility of a healed scar. Mobility is checked by placing the hand or fingertips on or around it. By moving the scar in different directions, the skin's displacement in relation to the fascia is checked. Apart from the free movement of the scar in all directions in the frontal plane, lifting should also be possible.
Vancouver Scar Scale
Time frame: up to 3 weeks
The VSS evaluates only 4 physical scar features-pigmentation, vascularity, pliability, and height-and the rater assigns an ordinal value for each feature Each feature has word descriptions for all possible options to help the rater assign a proper value. The values translate into numeric scores, which are then summed into an overall score ranging from 0 to 13 points.
Numeric Pain Rating Scale
Time frame: up to 3 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
Oswestry Disability Index
Time frame: up to 3 weeks
The Oswestry Disability Index is considered the 'gold standard' of low back functional outcome tools. It has 10 different sections. For each section the total possible score is 5. If all 10 sections are completed the score is calculated and interpreted in percentage measures.
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 3 Apr 2023.
- Background: PubMed 28167179Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
- BackgroundDaniszewska-Jarząb I. Manual scar therapy on the example of a caesarean section scar.
- Background: PubMed 34555964Ghavipanje V, Rahimi NM, Akhlaghi F. Six Weeks Effects of Dynamic Neuromuscular Stabilization (DNS) Training in Obese Postpartum Women With Low Back Pain: A Randomized Controlled Trial. Biol Res Nurs. 2022 Jan;24(1):106-114. doi: 10.1177/10998004211044828. Epub 2021 Sep 23.
- BackgroundHui T. Effective Physical Therapy Treatment of Post-Cesarean Section Low Back Pain-Case Report. J Adv Med Med Res. 2017;22:1-5.
- Background: PubMed 34091607Nayyab I, Ghous M, Shakil Ur Rehman S, Yaqoob I. The effects of an exercise programme for core muscle strengthening in patients with low back pain after Caesarian-section: A single blind randomized controlled trial. J Pak Med Assoc. 2021 May;71(5):1319-1325. doi: 10.47391/JPMA.596.
- Background: PubMed 30264849Sakamoto A, Nakagawa H, Nakagawa H, Gamada K. Effects of exercises with a pelvic realignment device on low-back and pelvic girdle pain after childbirth: A randomized control study. J Rehabil Med. 2018 Nov 7;50(10):914-919. doi: 10.2340/16501977-2487.
- Background: PubMed 30282349Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
- Background: PubMed 29979205Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
- BackgroundWasserman JB, Abraham K, Massery M, Chu J, Farrow A, Marcoux BC. Soft tissue mobilization techniques are effective in treating chronic pain following cesarean section: a multicenter randomized clinical trial. Journal of Women's Health Physical Therapy. 2018;42(3):111-9.
- Background: PubMed 31103106Wasserman JB, Copeland M, Upp M, Abraham K. Effect of soft tissue mobilization techniques on adhesion-related pain and function in the abdomen: A systematic review. J Bodyw Mov Ther. 2019 Apr;23(2):262-269. doi: 10.1016/j.jbmt.2018.06.004. Epub 2018 Jun 28.
- BackgroundYalfani A, Bigdeli N, Gandomi F. Effect of isometric-isotonic exercises of core stability in women with postpartum diastasis recti and its secondary disorders (randomized controlled clinical trial). J Health Care. 2020;22:123-37.
- Individual participant dataSharing planned: No
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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.
Ghulam Fatima, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scar mobilization techniques and Core stabilization exercises in people with Scar Tissue and Back Pain, 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 3 Apr 2023. 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?
Manual Scar mobility testing (time frame: up to 3 weeks). 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?
On the ClinicalTrials.gov record for NCT05355181, which also lists 11 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 3 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.