NCT05916807

Brief Summary

A randomized clinical trial study will be conducted through a non-probability convenience sampling technique. Study will be conducted at Jinnah Hospital, Lahore. Sample size will be collected through open epi tool. The total sample size of 52 is calculated. Two treatment groups will be taken for conducting the research. Group A with twenty-six (26) patients will be treated with stabilization exercises and Group B with twenty-six (26) patients whom will be treated with posture training. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For nonparametric data Wilcoxon signed rank test will be used. This is a non-parametric test that compares paired groups. Generalized physiotherapy rehabilitation protocol will be implemented in Group A for scapular stabilization by demonstrating scapular retraction (Shoulder Blade Squeezes), External Rotation, Shoulder Diagonals, Horizontal Rows, Shoulder Extension, Angel Wings, Active: Push with a plus, Physio ball Scapular Exercises, Platform Walks. In Group B, postural training different nursing positions will be guided as crossover hold, laid-back position, on the pillow position, cradle, football hold, side-lying position. The intervention will be provided in twelve sessions over a 4-week intervention period (three sessions per week) each session of 30 to 50 minutes accompanied by an individual daily at-home exercise program. The participants were advised not to use other forms of treatment during the trial (pharmacologic or non-pharmacologic treatment). NPRS will be used to measure the pain intensity and functional limitation will be assessed using the UEFI, goniometer to check the range limitation. Total study duration will be ten months after the approval of synopsis. Data will be analysed by using SPSS 26.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

December 5, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

June 14, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Breast feedingPainRange of motionScapular dyskinesis

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating scale

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

    4th week

  • UPPER EXTREMITY FUNCTIONAL INDEX

    The Upper Extremity Functional Index is a patient reported outcome measure used to assess the functional impairment in individuals with musculoskeletal upper limb dysfunction.

    4th week

  • RANGE OF MOTION

    A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.

    4th Week

Study Arms (2)

Stabilization Exercises

EXPERIMENTAL

Twenty-six (26) patients will be treated with stabilization exercises in breast feeding females suffering from scapular dyskinesia.

Other: Stabilization Exercises

Posture Training

EXPERIMENTAL

Twenty-six (26) patients will be treated with posture training of breast-feeding females suffering from scapular dyskinesia.

Other: Posture Training

Interventions

It consists of 26 patients who will receive stabilization exercises which will be divided in three components in lying posture, sitting, standing, rolling and kneeling positions to treat posterior, inferior muscles of scapula for 35-45 min for 3 days a week for 4 weeks.

Stabilization Exercises

It consists of 26 patients who will receive postural training and breast-feeding patterns for the mother and child for 35-45 min in 3 days a week for 4 weeks.

Posture Training

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Scapular Dyskinesis Test
  • Age 25-40 Years
  • Breast feeding females from last 6 months
  • Primigravida females

You may not qualify if:

  • Cesarean section females
  • Neck or shoulder pain due to any other comorbidity e.g. Previous history of trauma or fracture
  • Any spinal deformity like scoliosis or kyphosis
  • Disc prolapse facet joint stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Panagiotopoulos AC, Crowther IM. Scapular Dyskinesia, the forgotten culprit of shoulder pain and how to rehabilitate. SICOT J. 2019;5:29. doi: 10.1051/sicotj/2019029. Epub 2019 Aug 20.

    PMID: 31430250BACKGROUND
  • de Carvalho SC, Castro ADAE, Rodrigues JC, Cerqueira WS, Santos DDCB, Rosemberg LA. Snapping scapula syndrome: pictorial essay. Radiol Bras. 2019 Jul-Aug;52(4):262-267. doi: 10.1590/0100-3984.2017.0226.

    PMID: 31435089BACKGROUND
  • Ezeukwu OA, Ojukwu CP, Okemuo AJ, Anih CF, Ikele IT, Chukwu SC. Biomechanical analysis of the three recommended breastfeeding positions. Work. 2020;66(1):183-191. doi: 10.3233/WOR-203162.

    PMID: 32417825BACKGROUND

MeSH Terms

Conditions

Breast FeedingPain

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adeela Arif, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

December 5, 2022

Primary Completion

July 25, 2023

Study Completion

August 15, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations