Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females With Cesarean Section

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05979116
Collaborator
(none)
30
1
1
9
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: myofascial release
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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 .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 .
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females With Cesarean Section
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

this study group will receive abdominal myofascial release

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

Outcome Measures

Primary Outcome Measures

  1. pain level measurement [2 weeks]

    The pain level of each subject will be assessed before participation and after the end of the treatment by using NRS

  2. Scar mobility [2 weeks]

    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

  3. Pressure pain threshold [2 weeks]

    Pressure pain tolerance is defined as the force at which the subject asked for pressure to stop due to pain

  4. Neck ROM [2 weeks]

    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.

  5. Functional disability index [2 weeks]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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/inflammation at the site of scar.

  8. Any spinal deformity as kyphosis or scoliosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Amel youssef, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Asmaa Khalil Mohamed Khalil, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT05979116
Other Study ID Numbers:
  • P.T.REC/012/004050
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Asmaa Khalil Mohamed Khalil, assistant lecturer, Cairo University

Study Results

No Results Posted as of Aug 7, 2023