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Protocol summary
Inclusion criteria: Both male and female patients; Age group 18-39 years old; Only patients reporting pain on numeric pain rating scale above 4; Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Exclusion criteria: Patients with fibromyalgia; Individuals with any other deformity like scoliosis; Participant taking anti-inflammatory drugs will be excluded.
Inclusion criteria: Both male and female patients; Age group 18-40 years old; Only patients reporting pain on numeric pain rating scale above 4; Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Exclusion criteria: Patients with fibromyalgia; Individuals with any other deformity like scoliosis; Participant taking anti-inflammatory drugs will be excluded.
Inclusion criteria: Both male and female patients; Age group 18-3940 years old; Only patients reporting pain on numeric pain rating scale above 4; Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included. Exclusion criteria: Patients with fibromyalgia; Individuals with any other deformity like scoliosis; Participant taking anti-inflammatory drugs will be excluded.
General information
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2023-03-01, 1401/12/10
2023-03-01 00:00:00
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2023-06-09, 1402/03/19
2023-06-09 00:00:00
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2023-06-09, 1402/03/19
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trial completed
trial completed
Both male and female patients
Age group 18-39 years
Only patients reporting pain on numeric pain rating scale above 4
Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Both male and female patients
Age group 18-40 years
Only patients reporting pain on numeric pain rating scale above 4
Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Both male and female patients Age group 18-3940 years Only patients reporting pain on numeric pain rating scale above 4 Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Protocol summary
Study aim
To compare the effects of Bowen therapy and tennis ball technique on pain and functional disability in patients with thoracic myofascial pain syndrome
Design
This study will be Randomized Clinical Trial, parallel-group, triple blinded
Settings and conduct
The trial would be conducted in District Headquarters Hospital Kasur. it would be triple blinded, as the patients, assessor and analyzer would be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both male and female patients; Age group 18-40 years old; Only patients reporting pain on numeric pain rating scale above 4; Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Exclusion criteria: Patients with fibromyalgia; Individuals with any other deformity like scoliosis; Participant taking anti-inflammatory drugs will be excluded.
Intervention groups
Intervention group: group A will receive Bowen therapy, the position of ease will be produced and then small moves at varying pressure will be applied. The treatment will include light, cross-fibre manoeuvres of muscle, tendon with no forceful manipulation. one session will take 15-20 minutes.
Intervention group: group B will receive tennis ball technique, position of ease either standing or lying will be achieved, then placing a tennis ball between the body and the wall or floor, Rolling the ball across these areas for a short time will relax the knot. it will take 10 -15 minutes.
Main outcome variables
Pain; Functional Disability
General information
Reason for update
trial completed
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20190717044238N7
Registration date:2023-03-19, 1401/12/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:1
Registration date
2023-03-19, 1401/12/28
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
2023-03-06, 1401/12/15
Expected recruitment end date
2023-06-06, 1402/03/16
Actual recruitment start date
2023-03-01, 1401/12/10
Actual recruitment end date
2023-06-09, 1402/03/19
Trial completion date
2023-06-09, 1402/03/19
Scientific title
Comparative effects of Bowen therapy and tennis ball technique on pain and functional disability in patients with thoracic myofascial pain syndrome
Public title
Bowen therapy and tennis ball technique in patients with thoracic myofascial pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients
Age group 18-40 years
Only patients reporting pain on numeric pain rating scale above 4
Individuals fulfilling the criteria of five major(spontaneous pain, palpable taut band, localized sharp tenderness, referred pain, decreased ROM) and at least one out of three minor signs (pain on pressure, local twitch response (LTR), decrease in pain by muscle stretching) of myofascial pain syndrome will be included.
Exclusion criteria:
Patients with fibromyalgia
Individuals with any other deformity like scoliosis.
Participant taking anti-inflammatory drugs will be excluded
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
As per the inclusion and exclusion criteria of the study, patients will be divided into two grouos randomly by Random Number Generator table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Bowen therapy or tennis ball technique, The assessor of the outcomes would be blinded and lastly, our data analyzer would be blinded too, making it a triple blind clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethical Review Committee
Street address
Riphah Quaid e Azam Campus,28-M Quaid-e-Azam industrial Estate, Kot lakhpat,Lahore
City
Lahore
Postal code
54000
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
REC/RCR & AHS/23/0111
Health conditions studied
1
Description of health condition studied
Thoracic myofascial pain syndrome
ICD-10 code
M70.9
ICD-10 code description
Unspecified soft tissue disorder related to use, overuse and pressure
Primary outcomes
1
Description
Pain
Timepoint
Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes wiil be assessed at baseline, at the end of 2nd week (6th session) and at the end of the 4th week (12th session)
Method of measurement
Numeric Pain Rating Scale (NPRS)
Secondary outcomes
1
Description
Functional Disability
Timepoint
Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes wiil be assessed at baseline, at the end of 2nd week (6th session) and at the end of the 4th week (12th session)
Method of measurement
Pain Disability Questionnaire
Intervention groups
1
Description
Intervention group: group A will receive Bowen therapy, the position of ease will be produced and then small moves at varying pressure will be applied.The treatment will include light, cross-fibre manoeuvres of muscle, tendon with no forceful manipulation. one sessionwill take 15-20 minutes
Category
Treatment - Other
2
Description
Intervention group: group B will receive tennis ball technique, position of ease either standing or lying will be achieved, then placing a tennis ball between the body and the wall or floor, Rolling the ball across these areas for a short time will relax the knot. it will take 10 -15 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
DHQ hospital Kasur
Full name of responsible person
Dr. Anum Sarwar
Street address
Muslim town Lahore
City
Lahore
Postal code
54700
Phone
+92 333 6471197
Email
anumsarawar11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ripah international university Lahore
Full name of responsible person
Dr. Fareeha Amjad
Street address
Ripah international university Maddar e Millat Road, Quaid e Azam industrial Estate Lahore, Punjab
City
lahore
Postal code
54000
Phone
+92 334 3372779
Email
fareeha.amjad@ripah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Afsheen Khalid
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Khalid Mahmood House opposite Javaid Abdullah Khan Dhera, Kasur
City
Kasur
Province
Punjab
Postal code
55050
Phone
+92 324 4558262
Email
afsheenkhalid11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr. Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah Quaid e Azam Campus 28-M Quaid-e-Azam industrial Estate, kot lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Afsheen Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Khalid Mahmood House opposite Javiad Abdullah Khan Dhera, Kasur
City
Kasur
Province
Punjab
Postal code
55050
Phone
+92 324 4558262
Email
afsheenkhalid11@gmail.com
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
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
Yes - There is 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 will be available after the completion of research at the end of 2023
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 only used for Research Purposes
From where data/document is obtainable
Data can be asked for at the following email address: afsheenkhalid11@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.