IRCT | Effectiveness of pilates exercises with breathing re-education on pain, endurance, sleep and disability in working women with chronic non specific neck pain.

Protocol summary

Study aim: The aim of this study is to see effects of Pilates exercises with breathing reeducation on pain, endurance, sleep and disability in working women with chronic neck pain. This study show how non-invasive and effective treatments can improve the quality of life for working women with chronic neck pain.
Design: Two arm parallel group ,single blinded , single centered, randomized clinical trial.
Settings and conduct: Ghurki Trust Teaching Hospital Lahore, Pakistan.
Participants/Inclusion and exclusion criteria: INCLUSION CRITERIA: • Age 25-50 years old • Pain for more than 3 months • Females from white collar professions with daily 6 to 8 working hours per day • Pain intensity of less than or equal to 6 on NPRS EXCLUSION CRITERIA: • Cervical radiculopathy • Rheumatological conditions • History of trauma i.e., whiplash injuries • Neurological disorders such as stroke, Parkinson or multiple sclerosis • Tumor • Pregnancy, as it can affect pain perception and exercise tolerance • Respiratory condtions like asthma, COPD
Intervention groups: BREATHING RE-EDUCATION GROUP: The patients in the intervention group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs followed by breathing exercises for 15 minutes. The intervention was applied on alternate days for 6 weeks.
Main outcome variables: Pain, Endurance, Neck Disability, Sleep

General information

Reason for update
Acronym: PBNPS
IRCT registration information: IRCT registration number: IRCT20200226046623N2

Registration date: 2025-01-02, 1403/10/13

Registration timing: registered_while_recruiting

Last update: 2025-01-02, 1403/10/13

Update count: 0
Registration date: 2025-01-02, 1403/10/13

Registrant information: Name

sahreen Anwar

Name of organization / entity

The University of Lahore

Country

Pakistan

Phone

+92 41 8750106

Email address

sahreenanwar@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-10-31, 1403/08/10
Expected recruitment end date: 2025-04-20, 1404/01/31
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effectiveness of pilates exercises with breathing re-education on pain, endurance, sleep and disability in working women with chronic non specific neck pain.

Public title: role of Pilatese exercises with breathing reeducation in working women with chronic neck pain.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age 25-50 years old Pain for more than 3 months Females from white collar professions with daily 6 to 8 working hours per day • Pain intensity of less than or equal to 6 on NPRS

Exclusion criteria:

Cervical radiculopathy Rheumatological conditions Neurological disorders Pregnancy, as it can affect pain perception and exercise tolerance Respiratory conditions like COPD
Age: From 25 years old to 50 years old
Gender: Female

Phase

4

Groups that have been masked

Participant

Sample size

Target sample size: 52

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization was done using a computer generated block randomization scheme through "Random allocation" software. The blocks had different sizes(4,6,8) to ensure that the randomization process was unpredictable and to avoid selection bias. An automated randomization list was achieved with attrition rate included.

Blinding (investigator's opinion)

Single blinded

Blinding description

In this study only participants were blinded. This meant that participants were unaware of whether they were in breathing re-education group or pilates group.

Placebo

Not used

Assignment

Parallel

Other design features

It was a single blinded parallel randomized clinical trial.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethical Committee,Faculty of Rehabilitation Sciences, Lahore university of Biological and Applied Sc

Street address

Tulspura, Canal Bank ,North Lahore 53400

City

Lahore

Postal code

54000
Approval date: 2024-07-24, 1403/05/03
Ethics committee reference number: ERC/FORS/24/10

Health conditions studied

1

Description of health condition studied: Chronic Nack Pain
ICD-10 code: M54.2
ICD-10 code description: Cervicalgia

Primary outcomes

1

Description: Pain
Timepoint: Before intervention, and 3,6 weeks after intervention.
Method of measurement: Numeric Pain rating Scale (NPRS)

2

Description: Neck Disability
Timepoint: Before intervention, and 3,6 weeks after intervention.
Method of measurement: Neck Disability Index

Secondary outcomes

1

Description: Endurance
Timepoint: Before intervention, and 3,6 weeks after intervention.
Method of measurement: Craniocervical Flexion Test

2

Description: Sleep
Timepoint: Before intervention, and 3,6 weeks after intervention.
Method of measurement: Insomnia Severity Index (ISI)

Intervention groups

1

Description: Intervention group1:The patients in the intervention group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs followed by breathing exercises for 15 minutes, the intervention was applied on alternate days for 6 weeks.
Category: Treatment - Other

2

Description: Control group: The patients in the Pilates group received baseline treatment in the form of hot pack and neck isometric exercises 10*10 for 10 minutes. After wards patients performed mat Pilates exercises for 30 minutes including swan dive, neck rolls ,cervical spine retraction chin tucks ,nodding, shoulder shrugs . The intervention was applied on alternate days for 6 weeks.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Ghurki Trust Teaching Hospital,Lahore, Pakistan.

Full name of responsible person

Dr. Hassan Bin Akram

Street address

Band Road GT Road Link Jallo Morr Lahore

City

Lahore

Postal code

54300

Phone

+92 333 4774363

Email

mianhassan653@gmail.com

Web page address

1

Sponsor: Name of organization / entity

Lahore University of Biological and Applied Sciences

Full name of responsible person

Rahmeen Murtaza

Street address

20 Qasim Block Rizwan Garden,Lahore

City

Lahore

Postal code

54300

Phone

+92 321 4087737

Email

Rahmeenmaan2000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Lahore University of Biological And Applied Sciences
Proportion provided by this source: 100
Public or private sector: Private
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Other

Person responsible for general inquiries

Contact: Name of organization / entity

Lahore, University of Biological And Applied Sciences

Full name of responsible person

Sahreen Anwar

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Street#2 Sajid Garden Lahore

City

Lahore

Province

Punjab

Postal code

54300

Phone

+92 334 6591705

Email

Sahreenanwar@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Lahore University of Biological And Applied Sciences

Full name of responsible person

Sahreen Anwar

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Street#2 Rizwan Garden Lahore

City

Lahore

Province

Punjab

Postal code

54300

Phone

+92 334 6591705

Email

Sahreenanwar@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Lahore University of Biological and Apllied Sciences

Full name of responsible person

Sahreen Anwar

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

street#2 Sajid Garden Lahore

City

Lahore

Province

PUNJAB

Postal code

54300

Phone

+92 334 6591705

Email

sahreenanwar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: Data will only be available upon request depending on the purpose of acquisition of the data.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

Effectiveness of pilates exercises with breathing re-education on pain, endurance, sleep and disability in working women with chronic non specific neck pain.