Protocol summary
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Study aim
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To compare the effects of Bowen therapy and tennis ball technique on pain and functional disability in patients with thoracic myofascial pain syndrome
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Design
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This study will be Randomized Clinical Trial, parallel-group, triple blinded
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Settings and conduct
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The trial would be conducted in District Headquarters Hospital Kasur. it would be triple blinded, as the patients, assessor and analyzer would be blinded.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain; Functional Disability
General information
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Reason for update
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trial completed
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Acronym
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RCT
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IRCT registration information
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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
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Registration date
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2023-03-19, 1401/12/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-06, 1401/12/15
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Expected recruitment end date
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2023-06-06, 1402/03/16
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Actual recruitment start date
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2023-03-01, 1401/12/10
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Actual recruitment end date
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2023-06-09, 1402/03/19
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Trial completion date
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2023-06-09, 1402/03/19
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Scientific title
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Comparative effects of Bowen therapy and tennis ball technique on pain and functional disability in patients with thoracic myofascial pain syndrome
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Public title
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Bowen therapy and tennis ball technique in patients with thoracic myofascial pain syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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As per the inclusion and exclusion criteria of the study, patients will be divided into two grouos randomly by Random Number Generator table.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-02, 1401/10/12
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Ethics committee reference number
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REC/RCR & AHS/23/0111
Health conditions studied
1
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Description of health condition studied
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Thoracic myofascial pain syndrome
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ICD-10 code
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M70.9
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ICD-10 code description
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Unspecified soft tissue disorder related to use, overuse and pressure
Primary outcomes
1
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Description
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Pain
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Timepoint
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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)
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
Secondary outcomes
1
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Description
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Functional Disability
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Timepoint
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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)
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Method of measurement
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Pain Disability Questionnaire
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Riphah International University Lahore
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Consent form in its original format with no information about any participant study protocol- how the intervention was given to both groups
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When the data will become available and for how long
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Data will be available after the completion of research at the end of 2023
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To whom data/document is available
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People working in an academic and clinical setting can have access to the above mentioned information/documents
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Under which criteria data/document could be used
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Data can be only used for Research Purposes
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From where data/document is obtainable
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Data can be asked for at the following email address: afsheenkhalid11@gmail.com
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What processes are involved for a request to access data/document
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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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Comments
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