NCT06877728

Brief Summary

Neck pain is a common complaint among breastfeeding females, potentially attributed to sustained postures and muscle imbalance. Breastfeeding females experiencing neck pain, aged between 18-40 years, will be recruited through local healthcare facilities and community outreach. The physical demands of breastfeeding, such as prolonged postures and repetitive movements, can contribute to the development of musculoskeletal issues in the cervical region. Despite the prevalence of neck discomfort among breastfeeding females, there is a paucity of research exploring effective exercise interventions tailored to this specific population. Mothers' awareness of proper nursing positions during breastfeeding may have positive impact on the connection between mother and baby. Most typical positions for nursing a baby are cross cradle hold, cradle hold, side lying and football hold. Most common adapted breastfeeding position is cross cradle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Neck painrange of motionMuscle weaknessBreastfeeding

Outcome Measures

Primary Outcomes (4)

  • 1. Numeric Pain Rating Scale (NPRS)

    A Numeric Pain Rating Scale (NPRS) is a commonly used self-report measure to assess pain intensity. It typically involves asking individuals to rate their pain on a numerical scale. Below is a suggested format for a Numeric Pain Rating Scale questionnaire along with instructions and scoring guidelines. Scoring: Ask participants to circle the number on the scale that corresponds to their current pain intensity. The score is a single numeric value ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. The higher the score, the greater the perceived pain intensity. The NPRS is a widely used subjective pain measure that has good test-retest reliability (r=. 79-. 96)

    8 Weeks

  • NECK DISABILITY INDEX QUESTIONNARE

    The Neck Disability Index (NDI) is a widely used self-report questionnaire designed to assess disability related to neck pain. The questionnaire consists of 10 items that measure various aspects of daily activities affected by neck pain. Each item is scored on a 0 to 5 scale, and the total score is expressed as a percentage, with 0 indicating "no disability" and 5 indicating "complete disability. Format: 10 items evaluating concerns relating to neck pain. The participant selects the number that best describes their level of disability for each activity. The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain, intra class correlations can change between 0,50 and 0,98 (

    8 Weeks

  • INCLINOMETER NECK ROM:

    An inclinometer is a device used to measure the range of motion (ROM) of joints, including the neck, an inclinometer is often applied to measure flexion, extension, lateral flexion, and rotation of the cervical spine. The digital inclinometer demonstrated excellent reliability (ICC=0.75-0.86), except for the right lateral flexion (ICC=0.74) and left rotation (ICC=0.72)

    8 Weeks

  • MANUAL MUSCLE TESTING FOR MUSCLE WEAKNESS:

    Manual Muscle Testing (MMT) is a clinical and functional assessment technique used by healthcare professionals, such as physical therapists and physicians, to evaluate muscle strength and identify potential muscle weakness. It involves the application of resistance against a person's voluntary muscle contraction, and the resulting force is graded on a scale. 5/5: Normal strength (complete range of motion against gravity with full resistance) 4/5: Good strength (complete range of motion against gravity with moderate resistance) 3/5: Fair strength (complete range of motion against gravity with no resistance) 2/5: Poor strength (partial range of motion against gravity) 1/5: Trace movement (a flicker or trace of movement, but no joint motion) 0/5: No movement (complete paralysis)(

    8 Weeks

Study Arms (2)

Isometric exercises with conservative treatment

ACTIVE COMPARATOR

Will receive Neck isometrics exercises with conservative treatment. Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left.

Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)

Deep cervical flexion exercises with conservative treatment

OTHER

Will Deep cervical flexion exercises without conservative treatment. Deep cervical flexion exercises: 3 times weekly for 6 consecutive weeks (18 session) Duration: 10 to 15 repetitions with 3 sets, 30 sec rest given between each set. Exercise should target on deep cervical muscle rather than superficial muscle. Exercise should be conducted in supine position.

Other: Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions)

Interventions

Neck isometric exercises: 3 times weekly for 6 consecutive weeks (18 sessions) Duration: 10 to 15 repetitions with 3 sets, and 6 sec hold in flexion, extension and side flexion on both right and left.

Deep cervical flexion exercises with conservative treatmentIsometric exercises with conservative treatment

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreastfeeding females are included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 25 to 40 years
  • Mode of delivery (vaginal/c-section)
  • Severe neck weakness (above grade III)
  • Primigravida

You may not qualify if:

  • Previous history of upper extremity musculoskeletal symptoms
  • Radicular neck pain
  • History of inflammatory disease (myelopathy)
  • History of cervical fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 56700, Pakistan

Location

MeSH Terms

Conditions

Neck PainMuscle WeaknessBreast Feeding

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNervous System DiseasesPathologic ProcessesFeeding BehaviorBehavior

Study Officials

  • Faiza Taufiq, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants received scar mobilization combined with kinesio tapping
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

February 15, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations