NCT05355181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

April 21, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

CicatrixPelvic Girdle PainPostpartum Periodscarback pain

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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.

    up to 3 weeks

Study Arms (2)

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.

Other: Scar mobilization techniquesOther: 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.

Other: Scar mobilization techniques

Interventions

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.

Group A: scar mobilization and core stabilization exercises groupGroup B: scar mobilization techniques group

Core stabilization exercises

Group A: scar mobilization and core stabilization exercises group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafiqa hospital

Sargodha, Punjab Province, 54700, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 28167179BACKGROUND
  • Daniszewska-Jarząb I. Manual scar therapy on the example of a caesarean section scar.

    BACKGROUND
  • 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.

    PMID: 34555964BACKGROUND
  • Hui T. Effective Physical Therapy Treatment of Post-Cesarean Section Low Back Pain-Case Report. J Adv Med Med Res. 2017;22:1-5.

    BACKGROUND
  • 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.

    PMID: 34091607BACKGROUND
  • 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.

    PMID: 30264849BACKGROUND
  • 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.

    PMID: 30282349BACKGROUND
  • 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.

    PMID: 29979205BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31103106BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

CicatrixBack PainPelvic Girdle Pain

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMusculoskeletal PainPelvic Pain

Study Officials

  • Ghulam Fatima, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 2, 2022

Study Start

April 20, 2022

Primary Completion

October 30, 2022

Study Completion

November 30, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations