Protocol summary
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Study aim
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The aim is to study and compare the effects of shockwave therapy versus ultrasonic therapy and deep friction massage in patients with tennis elbow.
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Design
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Double Blind Parallel Arm Study. Randomized Clinical Trial.
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Settings and conduct
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This double blind (patient and outcome assessor will be blinded) parallel assignment study will be conducted in approximately one year at 2 settings;
1- Physiotherapy Department Syed Medical Complex, Sialkot Pakistan.
2- Physiotherapy Department Sialkot College of Physical Therapy, Amin Welfare & Teaching Hospital, Sialkot Pakistan.
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Participants/Inclusion and exclusion criteria
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Both male and female patients of 30-60 years of age with pain in twisting and turning movements of forearm. Patients with any history of trauma, surgery or presence of metal implant in elbow complex region, neurological deficits, radiculopathies and sensory impairments will be excluded.
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Intervention groups
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Group-A will be receiving shockwave therapy, Group-B will be administered Ultrasonic Therapy along with deep friction massage.
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Main outcome variables
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Patient Rated Tennis Elbow Evaluation Questionnaire and NPRS
General information
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Reason for update
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Trial completed.
we included special test, which we used while enrolling the patients and finding their eligibility to be included in the trial. The randomization is not changed but the control group was also another intervention that's why we want to update it as randomized clinical trial instead of randomized control trial.
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Acronym
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SWT
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IRCT registration information
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IRCT registration number:
IRCT20201031049207N4
Registration date:
2020-12-25, 1399/10/05
Registration timing:
registered_while_recruiting
Last update:
2023-07-31, 1402/05/09
Update count:
2
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Registration date
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2020-12-25, 1399/10/05
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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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2020-12-15, 1399/09/25
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Expected recruitment end date
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2021-05-14, 1400/02/24
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Actual recruitment start date
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2020-12-15, 1399/09/25
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Actual recruitment end date
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2021-12-20, 1400/09/29
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Trial completion date
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2022-02-23, 1400/12/04
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Scientific title
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Effects of Extra Corporeal Shock Wave Therapy versus Ultrasonic Therapy and deep friction message in the management of Lateral Epicondylitis.
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Public title
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Shockwave Therapy 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:
Both Males and Females.
Age between 30-60 years.
pain in twisting and turning movements of forearm.
Difficulty in holding weight in the affected side and walk.
Range of wrist extension complete but painful
Strength of extensor muscles Grade-IV
Positive Mill's test.
Positive Cozen's test
Exclusion criteria:
History of trauma in the region of Elbow complex.
Presence of any metal implant.
Any Neurological Deficits on the treatment sides
Symptoms of Cervical Radiculopathies.
Any sensory deficits.
strength of extensors less than Grade-IV
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Age
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From 30 years old to 60 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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
74
More than 1 sample in each individual
Number of samples in each individual:
1
Any patient may have a bilateral problem.
Actual sample size reached:
74
More than 1 sample in each individual
Actual sample size in each individual:
1
Any patient may have a bilateral problem.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be divided into two groups. In Group A (Experimental group) patients will have shock wave treatment and in patients Group B (Experimental group) will have ultrasonic therapy and deep friction massage using coin toss method and allocation sequence will be concealed through sealed envelopes.
Concealment of allocation: will be achieved with sequentially numbered, opaque, sealed, envelopes (SNOSE). SNOSE will be used according to guidelines of Doig and Simpson (25). An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 60 Envelopes will be prepared. Half envelops will contain folded papers with Treatment A written on them and the remaining half will contain folded papers with Treatment B written on them. A carbon paper will be inserted in each envelop with carbon side facing the paper so the allocation sequence, patient name, date of birth of participant and other information can be transferred onto allocation paper inside the envelope. A piece of tin foil is also inserted into envelop so the treatment card cannot be read against light. Envelops will be sealed and signed by the maker. A unique randomized number will be allocated to these envelops and shuffled vigorously. Then the envelops will be arranged sequentially and handed over to another independent researcher. Assessor will pretest the participant and if eligible envelope will be allocated to subject. Therapist will record the information on the envelope and open it afterwards to maintain the concealment. Assessor will record the post treatment findings and another independent analyst will analyze the data. This allocation of concealment will ensure the unpredictability of treatment allocation by investigators and patients.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In these patients assessor will be blinded to allocation of treatment groups in this study. Patient will be blinded to treatment allocation as treatment will be given in separate rooms for each group. Therapist who is not blinded will not take the outcome measurements.
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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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2020-11-16, 1399/08/26
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Ethics committee reference number
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IRB-SCPT-DPT-140-2020
Health conditions studied
1
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Description of health condition studied
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Lateral Epicondylitis or Tennis Elbow
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ICD-10 code
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M77.10
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ICD-10 code description
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Lateral epicondylitis, unspecified elbow
Primary outcomes
1
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Description
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Patient Rated Tennis Elbow Evaluation
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Timepoint
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one Pre-Treatment, one after 3rd visit and 3rd after 7th visit
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Method of measurement
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subjective assessment of the patient
2
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Description
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Pain
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Timepoint
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before 1st treatment session, after 3rd treatment session and after 7th session
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Method of measurement
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Numeric Pain Rating scale
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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before 1st treatment session and after last treatment session
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Method of measurement
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questionnaire SF-36
Intervention groups
1
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Description
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Intervention group: Group-A shock wave therapy group will be administered shockwave therapy with decompression on lateral side of elbow, with frequency 1Hz, energy level 2.0, for 7 sessions with gap of 4 days in each session.
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Category
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Treatment - Devices
2
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Description
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Intervention group: Group-B Ultrasonic therapy and deep friction massage group. patients will be provided with ultrasonic therapy 2.5w/sec2 (intermittent) 3 times a week for four weeks. deep friction massage will be an adjunct to ultrasonic therapy.
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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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none
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Proportion provided by this source
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1
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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there is no further information.
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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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Yes - There is 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Effects of Shockwave therapy versus ultrasonic and deep friction massage in the management of Lateral Epicondylitis. outcomes of the effects of treatment modality will be shared after completion of the study.
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When the data will become available and for how long
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after completion of study (January 2022).
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To whom data/document is available
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further information can be requested to principal investigator by those who are working in academic institutions and are interested to apply extra corporeal shockwave in tennis elbow.
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Under which criteria data/document could be used
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the data may be used as a reference after the study has been completed and published. Principal investigator will review the requests himself on predefined review criteria and respond accordingly.
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From where data/document is obtainable
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Any applicant can contact Principle investigator/ person responsible for scientific inquiries via email to request the sharing of data.
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What processes are involved for a request to access data/document
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The data can be accessed by direct request via email to the Principal investigator/ person responsible for scientific inquiries. He will respond in 10 working days positively.
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Comments
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