- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06817135
Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain
February 10, 2025 updated by: Saadyya Ahmed Abdalhamed Aladawi
The purpose of this study is to determine whether scapular stabilization exercises can help breastfeeding women with non-specific neck pain by reducing their neck pain, cervical range of motion, and neck disability index.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The best infant feeding practice is breastfeeding, which has both immediate and long-term advantages for mothers, babies, the environment, the economy, and society as a whole.
Mothers who are nursing frequently experience neck pain.
Because the scapula and neck are closely related, scapular stabilization is becoming more and more popular for patients with neck pain.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saadyya A. Abdalhamed Aladawi, Asst Lect
- Phone Number: 00201116364807
- Email: dr.saadyya@gmail.com
Study Contact Backup
- Name: Dr.Afaf M. Mahmoud Botla, Asst. Prof
- Phone Number: Assistant Professor
- Email: drafafmohamed@yahoo.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt, 12613
- Recruiting
- Faculty of Physical Therapy/ Cairo University
-
Contact:
- Saadyya A. Aladawi, Asst Lect
- Phone Number: 0020116364807
- Email: dr.saadyya@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- exclusive breastfeeding mothers with immediate to 6-month-old infants.
- The bilateral cradle position is employed by patients when nursing.
- Patients had mechanical neck pain.
- Patients with a body mass index below 30 kg/m²
- Patients have moderate pain intensity, ranging from 3 to 7 on the visual analogue scale
- The patients' scores on the Neck Disability Index ranged from 10 to 40 out of 50.
Exclusion criteria:
- Patients had preterm babies or low-birth-weight babies.
- pregnant patients
- Patients had postpartum complications.
- Patients had inflammation, infection, severe degeneration, congenital deformity, and trauma.
- Patients had sensory abnormalities or a positive motor reflex.
- Patients had cancer, metabolic, or systemic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
Got a standard physical therapy program, muscle energy technique for (sternocleidomastoid, elevator scapulae, upper trapezius and pectoralis major) and advice
|
Muscle Energy Technique for the 1.sternocleidomastoid 2. levator scapulae 3. upper trapezius 4. pectoralis major Through mild isometric contractions, it uses the intrinsic energy of a muscle to lengthen it and induce relaxation through autogenic inhibition.
Other Names:
The patients sit with their backs supported with pillows.
Don't lean over the infant.
Keep the arms supported and feet on the ground.
|
|
Experimental: Experimental group
got the same conventional physical therapy program plus scapular stabilization exercises.
|
Muscle Energy Technique for the 1.sternocleidomastoid 2. levator scapulae 3. upper trapezius 4. pectoralis major Through mild isometric contractions, it uses the intrinsic energy of a muscle to lengthen it and induce relaxation through autogenic inhibition.
Other Names:
The patients sit with their backs supported with pillows.
Don't lean over the infant.
Keep the arms supported and feet on the ground.
Cools exercise using the Thera-Band, including sidelying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation, and prone extension exercises to promote lower trapezius and middle trapezius activity with minimal activation of the upper trapezius part.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional neck disability
Time Frame: at beginning of the study and after four weeks of treatment
|
The Arabic version of the Neck Disability Index Questionnaire (NDI) is used to assess the functional neck disability.
It consists of 10 items; each item scores from 0 to 5, where a score of 0 indicates no limitation and a score of 5 indicates maximum limitation.
|
at beginning of the study and after four weeks of treatment
|
|
neck pain intensity
Time Frame: at beginning of the study and after four weeks of treatment
|
The Visual Analog Scale VAS was used to assess neck pain intensity for both groups at the beginning of the study and after four weeks of treatment.
It is a 10 cm line.
0 means no paint and 10 means maximum pain and the patient chooses a point on the line which reflects the pain
|
at beginning of the study and after four weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain threshold
Time Frame: at beginning of the study and after four weeks of treatment
|
The local pressure pain threshold over the upper trapezius was measured using a pressure algometer.
It is a portable digital algometer that responds linearly to force applications between 0 and 1300 kPa, or roughly 0 and 14 kg.
With a 1-cm² circular rubber tip, the device measures the maximum force applied before the subject verbally indicates that the pain threshold has been reached.
|
at beginning of the study and after four weeks of treatment
|
|
cervical range of motion
Time Frame: at beginning of the study and after four weeks of treatment
|
The cervical range of motion (flexion, extension, lateral flexion (Rt & Lt), and rotation (Rt & Lt)) is measured with a universal goniometer.
|
at beginning of the study and after four weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prof. Dr. Amel M. Yousef, Prof., Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nitayarak H, Charntaraviroj P. Effects of scapular stabilization exercises on posture and muscle imbalances in women with upper crossed syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(6):1031-1040. doi: 10.3233/BMR-200088.
- Abd El-Azeim AS, Mahmoud AG, Mohamed MT, El-Khateeb YS. Impact of adding scapular stabilization to postural correctional exercises on symptomatic forward head posture: a randomized controlled trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):757-766. doi: 10.23736/S1973-9087.22.07361-0. Epub 2022 Jun 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
February 5, 2025
First Submitted That Met QC Criteria
February 5, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- scapular stabilization ex.
Drug and device information, study documents
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.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Qatif Central HospitalEnrolling by invitationNeck Pain | Neck Pain MusculoskeletalSaudi Arabia
Clinical Trials on Muscle Energy Technique
-
Riphah International UniversityRecruitingUpper Cross SyndromePakistan
-
Foundation University IslamabadRecruiting
-
Lahore University of Biological and Applied SciencesLahore UBASNot yet recruitingAxillary Web Syndrome | Post-mastectomy
-
Riphah International UniversityCompleted
-
Riphah International UniversityNot yet recruitingLateral EpicondylitisPakistan
-
University of North GeorgiaUnknownRelaxation; Joint | Limitation, Mobility | Relaxation; LumbosacralUnited States
-
Riphah International UniversityRecruitingPiriformis SyndromePakistan
-
Cairo UniversityRecruitingNeck Pain | Breast FeedingEgypt
-
Riphah International UniversityCompleted
-
IQRA UniversityDow University of Health Sciences; Sindh Institute of Physical Medicine and...RecruitingNeck Pain | Chronic Neck PainPakistan