Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain Among Breastfeeding Females.

March 10, 2025 updated by: Riphah International University

Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain, Functional Disability, Range of Motion and Muscle Weakness Among Breastfeeding Females

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized control trial will be conducted to assess and compare the effectiveness of neck isometrics and deep cervical flexion exercises in alleviating neck pain, reducing disability, improving range of motion, and addressing muscle weakness in breastfeeding females. A sample size of 48 lactating women will be taken. Data will be collected from private clinical setups of Bahawalpur by using (NPRS) Numeric Pain Rating Scale Questionnaire, (NDI) Neck Disability Index, Range of motion will be assessed by inclinometer and Muscle strength will be assessed by MMT. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. Group A will be given Neck Isometric Exercises and Conservative treatment for 30 min (3-4days/week) of duration for total 6 weeks.

Group B will be given Deep Cervical Flexion Exercises with conservative treatment. The interventions will be provided for 30 minutes for 3-4 Day/week for 6 weeks. All participants in both groups will be evaluated before and after the treatment programs. Outcome measures will be calculated after 6 weeks of intervention. Data will be analyzed by using SPSS 21

Study Type

Interventional

Enrollment (Actual)

48

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 56700
        • Jinnah Hospital

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

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Isometric exercises with conservative treatment
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)
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: Deep cervical flexion exercises with conservative treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Numeric Pain Rating Scale (NPRS)
Time Frame: 8 Weeks

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
Time Frame: 8 Weeks

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:
Time Frame: 8 Weeks
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:
Time Frame: 8 Weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Faiza Taufiq, PP-DPT, Riphah International University

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)

February 15, 2024

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S23C14G92015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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