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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05979116
Other study ID # P.T.REC/012/004050
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date May 2024

Study information

Verified date July 2023
Source Cairo University
Contact Asmaa khalil
Phone 01004032103
Email dr.asmaakhalil@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

irty females with neck pain will participate in this study. Subjects will receive treatment session of thirty minutes in length in order to minimize tissue irritation and avoid increased tension of the scar area, which would counter the goal of the session. Treatment sessions will be provided biweekly for two weeks apart in order to allow physiological and biomechanical healing time between treatment sessions. MFR techniques will be employed to release the caesarean scar and myofascia of the DFL of each subject. The depth of the scar in this study takes us through all the layers from the skin to the uterus, following the surgical incision procedure. MFR was the primary treatment applied to the accessible structure of the patients' DFL, through Myers's MFR techniques of DFL. MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date February 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: 1. Female patients suffering from chronic neck pain since more than 3 months. 2. They underwent CS since at least 2 year before entry into study. 3. Not suffering from neck pain before CS 4. Their age will range from 20 to 35 years. 5. They will be primiparous 6. Body mass index (BMI) will range from 20-30 kg/m2. Exclusion Criteria: 1. Pregnancy. 2. BMI over 30 kg/m2. 3. Less than six months after CS. 4. History of pathologies resulting in weakening of connective tissue (diabetes, neoplasms, rheumatic illnesses). 5. Any abdominal surgeries other than caesarean sections. 6. Any head or neck trauma. 7. Skin irritation/in?ammation at the site of scar. 8. Any spinal deformity as kyphosis or scoliosis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
myofascial release
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

Locations

Country Name City State
Egypt Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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; — View Citation

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. — View Citation

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/medicina560 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain level measurement The pain level of each subject will be assessed before participation and after the end of the treatment by using NRS 2 weeks
Primary 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
Primary Pressure pain threshold Pressure pain tolerance is defined as the force at which the subject asked for pressure to stop due to pain 2 weeks
Primary 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
Primary 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
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