Protocol summary
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Study aim
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This study aims to compare the effects of blood flow restriction training and routine physical therapy on clinical and functional outcomes in patients with lateral epicondylitis.
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Design
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Parallel groups randomized clinical trial with blinded outcome assessment
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Settings and conduct
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This clinical trial is conducted at Wasim General & Orthopaedic Hospital Gojra. The patients in control group have received routine physical therapy treatment including application of TENS, moist heat pad and stretching exercises (06 reps with10 secs hold) and strengthening exercises (10 reps with 10 secs of resistance application). The patients in experimental group have received blood flow restriction resistance training in addition to routine physical therapy treatment. In this training, limb occlusion pressure (LOP) is measured of affected upper limb. BP cuff is applied at deltoid level to restrict the blood flow at 30% LOP and then patient is asked to perform resistance exercises in 04 sets with 30 reps in 1st set and 15 reps in other 03 sets. Each participant(of both group)has 03 session per week for 06 weeks. Only data assessor is blinded.
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Participants/Inclusion and exclusion criteria
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Patients of both genders having diagnosed unilateral tennis elbow in 20-50 years of age are included in the study.
Patients who received steroid injections for tennis elbow in last 06 months, patients having cardiovascular diseases, bleeding disorders, peripheral diseases, hypertension, hypotension, tumor, trauma, systematic or skin diseases are excluded from the study.
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Intervention groups
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There are two intervention groups. The control group is receiving routine physical therapy treatment alone and experimental group is receiving blood flow restriction training along with routine physical therapy treatment.
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Main outcome variables
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The study outcome variables are pain, range of motion, functional disability and quality of life.
General information
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Reason for update
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To update contact information
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Acronym
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BRF Training
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IRCT registration information
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IRCT registration number:
IRCT20220904055878N1
Registration date:
2022-11-30, 1401/09/09
Registration timing:
retrospective
Last update:
2024-03-04, 1402/12/14
Update count:
1
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Registration date
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2022-11-30, 1401/09/09
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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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2022-06-01, 1401/03/11
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Expected recruitment end date
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2022-07-31, 1401/05/09
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Actual recruitment start date
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2022-07-18, 1401/04/27
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Actual recruitment end date
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2022-08-20, 1401/05/29
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Trial completion date
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2022-10-20, 1401/07/28
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Scientific title
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Effects of blood flow restriction training and routine physical therapy on clinical outcomes in patients with lateral epicondylitis
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Public title
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Blood Flow Restriction Training Treatment in Tennis Elbow
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients diagnosed with unilateral tennis elbow
20-50 years of age among both genders
Exclusion criteria:
Patients who received steroid injections for tennis elbow in last 06 months
Cardiovascular diseases
Bleeding disorders and peripheral vascular diseases
History of hypertension or hypotension
Tumor
Trauma
Systematic diseases
Skin diseases
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Age
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From 20 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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2
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
72
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Concealed envelops were used for the randomization of the participants into intervention and control groups
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessor and data analyzer are blinded by labelling the experimental and control groups with unidentifying symbols
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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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2022-07-18, 1401/04/27
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Ethics committee reference number
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REC-UOL-/174-07/2022
Health conditions studied
1
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Description of health condition studied
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The Lateral Epicondylitis (Tennis Elbow)
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ICD-10 code
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M77.1
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ICD-10 code description
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Tennis Elbow, Lateral Epicondylitis, Blood Flow Restriction Training Treatment
Primary outcomes
1
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Description
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Pain
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Timepoint
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At the baseline, at the end of 3rd week, at the end of 6th week
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Method of measurement
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Visual Analogue Pain Scale
2
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Description
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Ranges of Motion (including wrist flexion, wrist extension, supination, pronation and elbow flexion)
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Timepoint
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At baseline, at the end of 3rd week and at the end of 6th week
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Method of measurement
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Goniometer
3
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Description
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Functional Disability
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Timepoint
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At the baseline, at the end of 3rd week and at the end of 6th week
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Method of measurement
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Patient Rated Tennis Elbow Evaluation Questionnaire
4
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Description
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Quality of Life
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Timepoint
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At the baseline, at the end of 3rd week and at the end of 6th week
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Method of measurement
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36- Item Short Form Survey (SF-36)
Intervention groups
1
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Description
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Control group: Routine Physical Therapy Treatment
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Category
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Rehabilitation
2
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Description
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Intervention group: Blood Flow Restriction Training along with Routine Physical Therapy Treatment
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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The University of Lahore
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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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Yes
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Title of funding source
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The University of 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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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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Undecided - It is not yet known if there will be 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