NCT05636462

Brief Summary

The significance of this study is that it will add to the growing body of knowledge that if these techniques yield outcomes in treatment of neck pain in breast feeding mothers. This study will add the beneficial effects to treat the neck pain in breast feeding females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 5, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

November 24, 2022

Last Update Submit

June 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Neck pain

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni dimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. Validity 0.86 to 0.95

    4th day

  • Neck Disability Index

    The most used neck disability questionnaires are the Neck Pain and Disability scale (NPAD) and the Neck Disability Index (NDI) The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability,reliability between 0,50 and 0,98

    4th day

Study Arms (2)

Global postural re-education

EXPERIMENTAL

It consists of 27 patients who will receive conventional exercises and global postural re-education which will be divided in three components First in lying posture to stretch anterior muscles of neck for 15 min, second component in supine position and stretching posterior muscles for 15 min and final component is in standing position under a load of gravity for 5 min for 3 days a week .

Other: Global postural re-education program

Conventional Physical therapy

ACTIVE COMPARATOR

It consists of 27 patients who will receive conventional therapy including stretching and strengthening exercises of neck for 3 days a week.

Other: Conventional Physical Therapy

Interventions

Different postures of global re-education programs are used and stretch is applied in these postures. 3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks.

Global postural re-education

Isometrics and stretching is used as conventional treatment. 3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks.

Conventional Physical therapy

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 25-35 Years
  • Mothers who have pain score of 4 in NPRS
  • Mothers who breast feed their babies
  • Post-partum period

You may not qualify if:

  • Neck pain due to any other comorbidity e.g. Previous history of trauma or fracture, disc prolapse, facet joint stenosis
  • Previously kyhoscoliotic mothers
  • Females who have C-section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.

    PMID: 34682453BACKGROUND
  • Somarajan S, Hingarajia D. Effect of Global Postural Re-Education and Static Stretching on Pain and Disability in Women with Chronic Non-Specific Neck Pain-A Comparative Study. Indian Journal of Public Health Research & Development. 2021;12

    BACKGROUND
  • Cavalcanti IF, Antonino GB, Monte-Silva KKD, Guerino MR, Ferreira APL, das Gracas Rodrigues de Araujo M. Global Postural Re-education in non-specific neck and low back pain treatment: A pilot study. J Back Musculoskelet Rehabil. 2020;33(5):823-828. doi: 10.3233/BMR-181371.

    PMID: 31929138BACKGROUND

MeSH Terms

Conditions

Neck PainBreast Feeding

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Adeela Arif, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

January 5, 2022

Primary Completion

January 25, 2023

Study Completion

March 15, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations