Protocol summary
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Study aim
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The main objective of this study was to determine the effect of myofascial release and PNF on improvement in pain, range of motion and functional status in patient suffering with supraspinatus tendonitis
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Design
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It will be single blinded randomized clinical trial. Study population that will suffering from supraspinatus tendinitis. 30 participants will be recruited according to criteria. Lottery method will be performed for allocation for participants in two groups.
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Settings and conduct
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The data will be collected from
• MTH Hospital Faisalabad, PT OPD
• DHQ Hospital Faisalabad, PT OPD
• Allied Hospital Faisalabad, PT OPD
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Participants/Inclusion and exclusion criteria
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6 Inclusion criteria
Participants who were socially active
• Age;30-50years
• Gender males and females
• Pain on VAS 5-7
• Participants of Faisalabad
Exclusion criteria
• Patients with the history of Infections
• Previous shoulder Surgery
• Previous shoulder Fracture
• Previous implants of shoulder
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Intervention groups
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According to inclusion and exclusion criteria 30 diagnosed subjects were enrolled into 2 groups, 15 patients in each group. A questionnaire filled by the subjects. Group A will receive moist heat (15 minutes) and myofascial release 3 sessions per week for 4 weeks, group B will receive moist heat (15 minutes) and proprioceptive neuromuscular facilitation 3 sessions per week for 4 weeks.
Three readings were taken pre reading before any treatment, mid reading after 6 sessions and third reading after 12 sessions.
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Main outcome variables
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• Reducing pain
• Improving functional disability
• Increasing range of motion
General information
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Reason for update
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update date of recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230904059353N1
Registration date:
2023-11-19, 1402/08/28
Registration timing:
prospective
Last update:
2023-11-30, 1402/09/09
Update count:
1
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Registration date
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2023-11-19, 1402/08/28
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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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2023-11-20, 1402/08/29
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Expected recruitment end date
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2023-12-26, 1402/10/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative Effects of Myofascial Release (Direct Deep Stroke) and Proprioceptive Neuromuscular Facilitation (Hold Relax) IN Supraspinatus Tendinitis: A randomized clinical trial
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Public title
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physiotherapy for patients suffering with supraspinatus tendonitis
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ; 30-50 year
Gender; Both Male and Female
Pain; 5-7 on VAS
Exclusion criteria:
Patients with history of infection
Previous surgery of shoulder
Previous shoulder fracture
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Age
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From 30 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This, randomized clinical trial employed a convenient sampling technique to recruit 30 eligible subjects who met the inclusion and exclusion criteria. Each participant provided informed consent prior to their involvement in the study. Following the enrollment phase, Lottery method was used to randomly allocated the participant into two treatment groups.15 patients were present in each group. For lottery method, each patient was asked to pick one paper from two pieces of paper, with group A and group B written on them. Participants were divided into treatment groups according to the paper they choose. After completing 15 patients in one group, all other participants was assigned to the other treatment group, so that both groups have equal participants.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants will not be known in which group they will be allocated
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Placebo
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Not used
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Assignment
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Other
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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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2023-03-03, 1401/12/12
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Ethics committee reference number
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TUF/IRB/2023
Health conditions studied
1
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Description of health condition studied
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Supraspinatus tendonitis
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ICD-10 code
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soft tissu
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ICD-10 code description
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M75.31
Primary outcomes
1
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Description
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Shoulder pain
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Timepoint
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Shoulder pain will be assessed three times before start of 1 session, after 2 weeks and after 4 weeks.
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Method of measurement
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Visual analogue scale
2
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Description
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Shoulder range of motion
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Timepoint
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Shoulder pain will be assessed three times before start of 1 session, after 2 weeks and after 4 weeks.
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Method of measurement
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Goniometer
3
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Description
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Shoulder disability
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Timepoint
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Shoulder pain will be assessed three times before start of 1 session, after 2 weeks and after 4 weeks.
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Method of measurement
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Shoulder pain and disability index
Intervention groups
1
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Description
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Intervention group A will receive 3 sessions of myofascial release per week for 4 weeks.
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Category
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Treatment - Other
2
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Description
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Intervention group B will receive 3 sessions of proprioceptive neuromuscular facilitation for 4 weeks.
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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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All financial expenses will be born by myself
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available