NCT07037056

Brief Summary

Breastfeeding, though essential for the nourishment and development of newborns, often imposes significant musculoskeletal strain on mothers, particularly in the neck and shoulder regions. Prolonged static postures, repetitive feeding routines, and improper ergonomic positions contribute to mechanical stress, leading to chronic discomfort or pain during the postpartum period Postnatal women frequently assume awkward positions while nursing, such as forward head posture, rounded shoulders, and spinal flexion, which contribute to musculoskeletal dysfunctions . The cumulative load on the musculoskeletal and fascial systems during breastfeeding leads to muscle imbalances, myofascial tightness, and trigger point development.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

March 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is an 11-point scale used to measure pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).

    6 Month

  • Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a questionnaire used to assess how neck pain affects a person's daily life and disability. It consists of 10 items, each scored on a 0-5 scale, resulting in a total score ranging from 0 to 50. A higher score indicates greater perceived disability due to neck pain

    6 Months

  • Breastfeeding self efficacy scale

    All items are preceded by the phrase ''I can always'' and rated on a 5-point Likert scale, ranging from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy

    6 months

Study Arms (2)

Shoulder and Neck Strengthening + Postural Correction Exercises

EXPERIMENTAL
Combination Product: Shoulder and Neck Strengthening + Postural Correction Exercises

Shoulder and Neck Strengthening + soft tissue mobilization

ACTIVE COMPARATOR
Combination Product: Shoulder and Neck Strengthening + soft tissue mobilization

Interventions

Physiotherapy exercises of Shoulder and Neck Strengthening + Postural Correction Exercises for shoulder and neck pain

Shoulder and Neck Strengthening + Postural Correction Exercises

Physiotherapy exercises of Shoulder and Neck Strengthening + soft tissue mobilization Exercises for shoulder and neck pain

Shoulder and Neck Strengthening + soft tissue mobilization

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum period of up to 12 months

You may not qualify if:

  • History of trauma or cervical disc pathology
  • Neurological disorders
  • Previous musculoskeletal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore City

Lahore, Pakistan

Location

MeSH Terms

Conditions

Shoulder PainNeck Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

March 4, 2025

Primary Completion

June 1, 2025

Study Completion

September 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations