NCT06817135

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

June 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 5, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

scapular stabilization exerciseBreast feeding women

Outcome Measures

Primary Outcomes (2)

  • functional neck disability

    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

    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 Outcomes (2)

  • pressure pain threshold

    at beginning of the study and after four weeks of treatment

  • cervical range of motion

    at beginning of the study and after four weeks of treatment

Study Arms (2)

control group

ACTIVE COMPARATOR

Got a standard physical therapy program, muscle energy technique for (sternocleidomastoid, elevator scapulae, upper trapezius and pectoralis major) and advice

Other: Muscle Energy TechniqueOther: Advice about the right the breastfeeding ergonomic.

Experimental group

EXPERIMENTAL

got the same conventional physical therapy program plus scapular stabilization exercises.

Other: scapular stabilization exercisesOther: Muscle Energy TechniqueOther: Advice about the right the breastfeeding ergonomic.

Interventions

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.

Experimental group

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.

Also known as: Autogenic Inhibition, Post Isometric Relaxation
Experimental groupcontrol group

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 groupcontrol group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreastfeeding mothers
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy/ Cairo University

Giza, Dokki, 12613, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35673945BACKGROUND
  • 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.

    PMID: 34151819BACKGROUND

Related Links

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Dr. Amel M. Yousef, Prof.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saadyya A. Abdalhamed Aladawi, Asst Lect

CONTACT

Dr.Afaf M. Mahmoud Botla, Asst. Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The control group got the standard physical therapy program, muscle energy technique for the sternocleidomastoid, elevator scapulae, upper trapezius, and pectoralis major, and advice, while the experimental group got the same conventional physical therapy program in addition to scapular stabilization exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ِِِAssistant Lecturer in the of Women's Health Department

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

June 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations