Protocol summary
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Study aim
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The main purpose of this study is to survey the effect of sending SMS and educational video link on the treatment outcomes regarding the range of motion of damaged fingers, grip strength and disability of hand as well as VAS score, MAYO score, and PRWE score on the patients with flexor tendon injuries.
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Design
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This randomized controlled trial (RCT) study is a 12-weeks, two-arm, parallel RCT to evaluate the effectiveness of a text message-based intervention, on primary and secondary outcomes of patients with flexor tendon injury after repair. Forty patients will be randomized in a 1:1 ratio to either the intervention group or the control group using an online random number generator and the sequence will be concealed in sequentially numbered sealed envelopes.
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Settings and conduct
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setting: Imam Reza Hospital in Mashhad
The study is randomized, one blinded, parallel and in a single center
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Participants/Inclusion and exclusion criteria
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Main inclusion criteria: Patients with flexor tendon injuries after repair
Exclusion criteria: Patients who have tendon injury with fracture
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Intervention groups
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Patients who are underwent flexor tendon repair in the intervention groups will receive text messages about postoperative care for 12 weeks at no cost the day after the patient is discharged from the hospital in addition to usual care.
Patients in the control group will receive only usual care.
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Main outcome variables
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Patient Rated Wrist Evaluation score
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170731035411N1
Registration date:
2017-12-14, 1396/09/23
Registration timing:
prospective
Last update:
2019-09-09, 1398/06/18
Update count:
1
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Registration date
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2017-12-14, 1396/09/23
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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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Deputy of Research of Mashhad University of Medical Sciences
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Expected recruitment start date
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2018-08-23, 1397/06/01
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Expected recruitment end date
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2019-09-21, 1398/06/30
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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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The effect of text message and educational videos on treatment outcomes of hand disability of patients with flexor tendon injuries
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Public title
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The effect of text message and educational videos on patients with tendon injuries
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients who have flexor tendon injury with no fracture
patients who are underwent flexor tendon repair
Patients who have a cell phone
Exclusion criteria:
Patients who do not agree to continue their cooperation
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Age
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From 18 years old to 65 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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- Care provider
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Method of randomization is simple individual randomization. We use a website for the random sequence using an online random number generator. A member of the research team will conceal the assignment of subjects to each group in sequentially numbered opaque, sealed envelopes.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Outcome assessor and care providers will be blinded in our study and they will not know the group of patients that their outcomes will be evaluated.
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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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2017-08-23, 1396/06/01
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Ethics committee reference number
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IR.MUMS.fm.REC.1396.247
Health conditions studied
1
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Description of health condition studied
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Hand flexor tendon injuries
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ICD-10 code
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S66.1
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ICD-10 code description
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Injury of flexor muscle, fascia and tendon of other and unspecified finger at wrist and hand level
Primary outcomes
1
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Description
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Patient Rated Wrist Evaluation score
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Timepoint
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sixth week and twelfth week after the start of the intervention
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Method of measurement
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Patient Rated Wrist Evaluation (PRWE) questionnaire
Secondary outcomes
1
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Description
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pain score
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Timepoint
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Sixth week and twelfth week after the start of the intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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Mayo Wrist Score
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Timepoint
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Sixth week and twelfth week after the start of the intervention
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Method of measurement
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Checklist
3
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Description
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GRIP strength
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Timepoint
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Sixth week and twelfth week after the start of the intervention
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Method of measurement
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ًًhydraulic hand dynamometer
4
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Description
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Disabilities of Arm, Shoulder & Hand score
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Timepoint
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Sixth week and twelfth week after the start of the intervention
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Method of measurement
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Quick-DASH questionnaire
Intervention groups
1
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Description
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Intervention group: patients in this group will receive text messages and video links about postoperative care for 12 weeks at no cost. The intervention will be provided in addition to usual care provided to all patients with flexor tendon injury after surgery.
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Category
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Rehabilitation
2
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Description
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Control group: patients will receive the usual care provided to all patients with flexor tendon injury after surgery.
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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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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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Mashhad University of Medical Sciences
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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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Public
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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