- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355181
Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain
Effects of Scar Mobilization Techniques With and Without Core Stability Exercises on Scar Tissue Mobility and Lumbopelvic Pain Following Cesarean Section
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Sargodha, Punjab, Pakistan, 54700
- Rafiqa hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: scar mobilization and core stabilization exercises group
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.
|
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 exercises
|
|
Active Comparator: Group B: scar mobilization techniques group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 3 weeks
|
|
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.
|
up to 3 weeks
|
|
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
|
up to 3 weeks
|
|
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.
|
up to 3 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Saleh 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.
- Daniszewska-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.
- Hui 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.
- Sakamoto 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.
- Teymuri 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.
- Wasserman 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.
- Yalfani 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/22/0504 Anam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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