Protocol summary

Study aim
To determine the effects of Daoyin training on pain, postural angles and quality of life in Upper- crossed syndrome Patients.
Design
It was a concealed, randomized, single blinded, sham controlled clinical trial with a parallel group design of 60 patients.
Settings and conduct
Study was conducted at Layyah city hospital of govt college university Faisalabad Layyah campus. The study population was consisted of patients with upper cross syndrome. The study was single blinded. The participants didn't know while they were receiving experimental or conventional treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged between 18-45 years, both genders, satisfied the diagnostic criteria raised by Asian Fitness Society for UCS Exclusion Criteria: Patients with neurological disorders (Thoracic outlet syndrome), musculoskeletal disorder (Rotator cuff injury), Inflammatory disease (e.g. Rheumatoid arthritis), history of Spine, shoulder fractures /dislocation
Intervention groups
Participants will be randomly allocated into two groups (Group A: DT group, Group B: CT group). The participants randomly allocated in Group A will be received the Thoracic and cervical Daoyin training. Participants will execute this training after 15 minutes of TENS and heat pack. This approach requires five sessions per week for eight weeks. Group B participants will have received treatment includes of TENS, hot pack for 15 min and other body strength exercises and stretches includes shoulder roll, scapular squeeze, wall angel, overhead arm stretch, Cat cow, Knee to chest, superman, trapezius and levator scapulae stretch.
Main outcome variables
Pain (Visual Analogue Scale), Postural Angles (Forward Shoulder Angle and Forward Head Angle), Quality of life ( Short Form Survey-12)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230731058990N2
Registration date: 2024-01-08, 1402/10/18
Registration timing: retrospective

Last update: 2024-01-08, 1402/10/18
Update count: 0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Kashaf Faraz
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 304 6541357
Email address
kashaf.fraz@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-14, 1402/06/23
Expected recruitment end date
2023-09-29, 1402/07/07
Actual recruitment start date
2023-09-28, 1402/07/06
Actual recruitment end date
2023-10-07, 1402/07/15
Trial completion date
2023-12-01, 1402/09/10
Scientific title
Effects of daoyin training on pain, postural angles and quality of life in upper cross syndrome patients
Public title
Daoyin training effects on pain, postural angles and quality of life in upper cross syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both gender Age is 25-45 years Their condition satisfied the diagnostic criteria raised by Asian Fitness Society for UCS
Exclusion criteria:
Patients with neurological disorders (Thoracic outlet syndrome) Patient with history of Spine, shoulder fractures /dislocation Inflammatory disease (e.g. Rheumatoid arthritis) Patients with musculoskeletal disorder (Rotator cuff injury)
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
  • Investigator
Sample size
Target sample size: 72
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
participants were randomized using gold fish bowl method into two groups, control and experimental. Treatment allocation were done by using concealed envelope method. In this, sealed opaque envelops with treatment regimen written were provided to the participants. Once a patient had consented to enter a trial room, an envelope was opened, and the patient was then offered the allocated treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blinded. The participants did not know while they were receiving experimental or routine physical therapy treatment. and yes, intervention is similar enough for blinding participants.
Placebo
Not used
Assignment
Parallel
Other design features
Visual Analogue Scale, Neck Disability, Posture, Upper Cross Syndrome

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee (REC)
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Postal code
54000
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
REC-UOL-527-08-2023

Health conditions studied

1

Description of health condition studied
Upper Cross Syndrome
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture

Primary outcomes

1

Description
Pain
Timepoint
Baseline, 4th and 8th week of treatment
Method of measurement
Visual Analogue Scale

2

Description
Postural Angles
Timepoint
Baseline, 4th and 8th week of treatment
Method of measurement
Forward Shoulder Angle and Forward Head Angle

3

Description
Quality of Life
Timepoint
Baseline, 4th and 8th week of treatment
Method of measurement
SF-12

Secondary outcomes

1

Description
Physical and mental health
Timepoint
Baseline, 4th and 8th week of treatment
Method of measurement
Short-Form 12

Intervention groups

1

Description
Group A received routine physical therapy which includes 15 minutes of electrical muscle stimulation with heat therapy. Hot packs will be used to deliver superficial heating. Each treatment session will be lasted 30-45 minutes. The participants randomly allocated in Group A will be received the Thoracic and cervical Daoyin training. Participants will execute this training after 15 minutes of TENS and heat pack. This approach requires five sessions per week for eight weeks. The cervical and thoracic "Daoyin" training in this study will be consisted of the five movements: (1) Dantian Gong (2) Turtle shrinking its neck (3) Roc spreading its wings (4) White goose stretching its neck (5) Tiger lying. The interval of each movement will be 30-60 s, and the duration will be 35- 40 min
Category
Rehabilitation

2

Description
Group B participants will be instructed to maintain daily activities and not partake in any further sports. Group B participants will have received treatment includes of TENS, hot pack for 15 min and other body strength exercises and stretches includes shoulder roll, scapular squeeze, wall angel, overhead arm stretch, Cat cow, Knee to chest, superman, trapezius and levator scapulae stretch.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Physical Therapy, DHQ Hospital Layyah
Full name of responsible person
Dr Khurram mahmood
Street address
DHQ hospital layyah
City
Layyah
Postal code
31200
Phone
+92 304 4407035
Email
mehmokhuram8@gmail.com
Web page address
https://dhqlayyah.punjab.gov.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Ashfaq Ahmad
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
+92 344 4535304
Email
ashfaaqpt@gmail.com
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UOL, Lahore
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Sania Naz
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1 - KM, Defence Rd, near Bhubattian, howk, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 304 4407035
Email
sania.naz642@gmail.com
Web page address
https://uol.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Kashaf Faraz
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 304 6541357
Email
kashaffraz@gmail.com
Web page address
https://uol.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Iqra Islam
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 313 4260161
Email
iqrawislam@gmail.com
Web page address
https://uol.edu.pk/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentiality
When the data will become available and for how long
data will be available from April 2024 to June 2024 after the 6 months of publication. The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's International Clinical Trials Registry Platform; this occur before the first participant is enrolled.
To whom data/document is available
Dr. Sania Naz (corresponding author) professor at UOL, lahore.
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
To the corresponding author of the study, Dr Sania Naz and can contact on +923044407035 saaniaanaz@gmail.com can visit these search engines, you can find my study easily here https://www.researchgate.net/ https://scholar.google.com/
What processes are involved for a request to access data/document
open-access and There is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by Director in Charge and in case of eligibility, it would be shared in two weeks
Comments
I want randomized clinical trial registration.
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