Protocol summary

Study aim
To compare the effects of myofascial release and Bowen therapy on pain, range of motion, disability and posture (craniovertebral angle, rounded shoulder angle) in patients with text neck syndrome:
Design
Randomized clinical trial, single blinded study, two parallel groups with 32 patients from University Of Lahore Teaching Hospital Lahore
Settings and conduct
The trial will be conducted at University Of Lahore Teaching Hospital Lahore. The participant will be blinded by concealment of the technique that will be used on the participant.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: Both male and female patients, 18-35 years of age, Using smartphones>2 hours a day patient having neck pain which is increased by sustained posture and feeling of stiffness on turning the head and neck after long usages, NPRS > 3, NDI ≥10, Craniovertebral angle<50°, Rounded shoulder angle>52°, Neck pain lasting more than 3 months EXCLUSION CRITERIA: Patients with any spinal infection or inflammatory disorder, Neck surgery or trauma or Malignancy, Torticollis, Scoliosis, Pregnancy, Diagnosed cases of disc prolapse, Stenosis, or Herniation, Spondylolisthesis, Osteoporosis, Those with current use of any medication or physical therapy treatment
Intervention groups
Group A: Myofascial release will be given to group A along with conventional therapy Group B: Bowen therapy will be given to group B along with conventional therapy
Main outcome variables
Pain intensity, Neck disability, Cervical ROM, Postural assessment

General information

Reason for update
Acronym
ceomrabtipwtns
IRCT registration information
IRCT registration number: IRCT20190717044238N10
Registration date: 2023-11-15, 1402/08/24
Registration timing: registered_while_recruiting

Last update: 2023-11-15, 1402/08/24
Update count: 0
Registration date
2023-11-15, 1402/08/24
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-02-28, 1402/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative effects of myofascial release and bowen therapy in patients with text neck syndrome
Public title
comparative effects of myofascial release and bowen therapy in patients with text neck syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients 18-35 years of age Using smartphones greater than 2 hours a day patient having neck pain which is increased by sustained posture and feeling of stiffness on turning the head and neck after long usage Numerical pain rating scale greater than 3 Neck disability index greater and equal to 10 Craniovertebral angle less than 50° Rounded shoulder angle greater and equal to 52° Neck pain lasting more than 3 months
Exclusion criteria:
Patients with any spinal infection or inflammatory disorder Neck surgery or trauma or Malignancy Torticollis Scoliosis Pregnancy Diagnosed cases of disc prolapse, Stenosis or Herniation Spondylolisthesis Osteoporosis Those with current use of any medication or physical therapy treatment
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by use of sealed envelops which involves assigning participants to different groups by randomly selecting an envelope that contains their group assignment. This will ensure reduce biasness in allocation of interventions. Simple randomization method is used to allocate participants to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the trial the participant is blinded by not knowing or being unaware which intervention they are receiving , but the researcher know. This trial will be single blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
REC/RCR&AHS/23/0140

Health conditions studied

1

Description of health condition studied
Text Neck Syndrome
ICD-10 code
M54.2
ICD-10 code description
cervicalgia, unspecified

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, 6 week
Method of measurement
Numerical pain rating scale

2

Description
Disability
Timepoint
Before intervention, 6 week
Method of measurement
Neck disability index

3

Description
Range of motion
Timepoint
Before intervention, 6 week
Method of measurement
Inclinometer

4

Description
Posture
Timepoint
Before intervention, 6 week
Method of measurement
Photographic method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Myofascial release will be given to group A along with the conventional treatment.This group patients will be treated with 10 mins of moist heat followed by Deep transverse friction massage therapist used ulnar border of both palms to release the fascia of cervical region (each treatment session for 20 to 30 min) Intervention was given for 6 weeks on alternate days(
Category
Rehabilitation

2

Description
Intervention group B: Bowen therapy will be given to group B along with the conventional treatment. These patients will receive 10 mins of moist heat and followed by Bowen Therapy top of the targeted muscle was touched by the therapist's (levator scapulae, sternocleidomastoid, upper trapezius, the scalene and suboccipital) Initially, the fingers will located onto the starting point with minimum pressure, and then the skin was engaged laterally or medially. Following this, downward pressure was applied to sink the tissue and held for 3–4 s to challenge the target tissue. Finally, the fingers were moved across the target tissue while maintaining pressure to disturb the underlying tissues The Bowen will perform as a pair with a 2–5 min pause between a set of moves(23). Each set was composed of 2–6 Bowen therapy (each session comprised of 20 to 30 mins) Intervention was given for 6 weeks on alternate days
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University Of Lahore Teaching Hospital
Full name of responsible person
Hadia Ibrar
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
lahore
Postal code
54590
Phone
+92 322 5631821
Email
hadiaibrar1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr. Fareeha Amjad
Street address
Riphah International University Lahore Gulberg green campus
City
Lahore
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University 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
Riphah International University Lahore
Full name of responsible person
Hadia Ibrar
Position
MS student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
46-Iqbal avenue phase 3 lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 322 5631821
Email
hadiaibrar1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fareeha Amjad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg green Campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International university Lahore
Full name of responsible person
Hadia Ibrar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg green campus
City
lahore
Province
Punjab
Postal code
54000
Phone
+92 322 5631821
Email
hadiaibrar1@gmail.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
confidentiality of participants
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Consent form in its original format with no information about any participant study protocol -how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research
To whom data/document is available
People working in an academic and clinical setting can have access to the above mentioned information/documents
Under which criteria data/document could be used
Data can be used for Research Purpose
From where data/document is obtainable
Data can be asked for at the following email address: hadiaibrar1@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data
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