NCT05979116

Brief Summary

To investigate the effect of abdominal myofascial release on pain, ROM and functional abilities of neck in females with CS scar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

July 29, 2023

Last Update Submit

December 16, 2024

Conditions

Keywords

cesarean sectionmyofascial release

Outcome Measures

Primary Outcomes (5)

  • pain level measurement

    The pain level of each subject will be assessed before participation and after the end of the treatment by using numerical rating scale. this scale have numbers from 0 to 10 with 0 means no pain at all and 10 means sever intolerable pain

    2 weeks

  • Scar mobility

    Subjects will lay supine on a plinth with arms at their sides and legs straight. Marks were made on the CS scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar, The examiner will use the marks to measure tissue extensibility in millimeters (mm) in each of four directions: superior/left/inferior/right by using adheremeter

    2 weeks

  • pressure pain threshold measurement

    Pressure pain threshold ( PPT) is defined as the force at which the subject asked for pressure to stop due to pain. The pressure algometer is an instrument used to assess PPT for musculoskeletal pain. It was used to measure PPT of neck muscles before and after the treatment program for each female. This device includes a 1 cm2 probe with a system to convert the force applied through a 1 cm2 pressure application surface to Newtons (N/cm2) or kilograms of force (kg/cm2), that appear on the display

    2 weeks

  • Neck ROM

    Neck ROM will be measured in a standardized sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight. Subject's ankles, knees and hips were positioned at right angle and arms were folded across the chest to minimize thoracic movement, with tongue depressor can be held between teeth for reference.

    2 weeks

  • Functional disability index

    The NDI is adapted from Oswestry Low Back Pain Disability Questionnaire. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability).

    2 weeks

Study Arms (1)

study group

EXPERIMENTAL

this study group will receive abdominal myofascial release

Other: myofascial release

Interventions

MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure. MFR techniques utilized with the cases include different variations of application: 1. Muscle was stroked in a long

study group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients suffering from chronic neck pain since more than 3 months.
  • They underwent CS since at least 2 year before entry into study.
  • Not suffering from neck pain before CS
  • Their age will range from 20 to 35 years.
  • They will be primiparous
  • Body mass index (BMI) will range from 20-30 kg/m2.

You may not qualify if:

  • Pregnancy.
  • BMI over 30 kg/m2.
  • Less than six months after CS.
  • History of pathologies resulting in weakening of connective tissue (diabetes, neoplasms, rheumatic illnesses).
  • Any abdominal surgeries other than caesarean sections.
  • Any head or neck trauma.
  • Skin irritation/inflammation at the site of scar.
  • Any spinal deformity as kyphosis or scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

Related Publications (3)

  • 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
  • Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.

    PMID: 18307483BACKGROUND
  • Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.

    PMID: 32471194BACKGROUND

Related Links

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Amel youssef

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a single group study as a study that consists of only a single group of subjects included in the study design, in which all subjects received a single intervention and the outcomes are assessed over time .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

August 1, 2023

Primary Completion

February 20, 2024

Study Completion

May 30, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations