Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain
Primary Purpose
Scar Tissue, Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Scar mobilization techniques
Core stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Scar Tissue focused on measuring Cicatrix, Pelvic Girdle Pain, Postpartum Period, scar, back pain
Eligibility Criteria
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.
Sites / Locations
- Rafiqa hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A: scar mobilization and core stabilization exercises group
Group B: scar mobilization techniques group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05355181
First Posted
April 21, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05355181
Brief Title
Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain
Official Title
Effects of Scar Mobilization Techniques With and Without Core Stability Exercises on Scar Tissue Mobility and Lumbopelvic Pain Following Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar Tissue, Back Pain
Keywords
Cicatrix, Pelvic Girdle Pain, Postpartum Period, scar, back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: scar mobilization and core stabilization exercises group
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: scar mobilization techniques group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Scar mobilization techniques
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core stabilization exercises
Intervention Description
Core stabilization exercises
Primary Outcome Measure Information:
Title
Manual Scar mobility testing
Description
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.
Time Frame
up to 3 weeks
Title
Vancouver Scar Scale
Description
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.
Time Frame
up to 3 weeks
Title
Numeric Pain Rating Scale
Description
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
Time Frame
up to 3 weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
up to 3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rafiqa hospital
City
Sargodha
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28167179
Citation
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Results Reference
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Citation
Daniszewska-Jarząb I. Manual scar therapy on the example of a caesarean section scar.
Results Reference
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PubMed Identifier
34555964
Citation
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.
Results Reference
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Hui T. Effective Physical Therapy Treatment of Post-Cesarean Section Low Back Pain-Case Report. J Adv Med Med Res. 2017;22:1-5.
Results Reference
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PubMed Identifier
34091607
Citation
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.
Results Reference
background
PubMed Identifier
30264849
Citation
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.
Results Reference
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PubMed Identifier
30282349
Citation
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.
Results Reference
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PubMed Identifier
29979205
Citation
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
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Citation
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.
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Results Reference
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Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain
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