Protocol summary
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Study aim
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This study aims to compare the effectiveness of patient-led goal setting with pain neuroscience education and Manual therapy in patients suffering chronic low back pain.
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Design
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A sample population of 45 subjects was purposefully selected using G-power statistical software. The volunteers are then equally divided into 3 groups (control group, patient-led goal setting group with pain neuroscience education and patient-led goal setting group with manual therapy).
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Settings and conduct
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Targeted individuals are randomly assigned to 3 groups of 15 people. Initially, the Start Back questionnaire will be used to evaluate and classify patients suffering from nonspecific chronic low back pain. Additionally, appropriate questionnaires will be used to assess pain intensity, disability, quality of life, depression / anxiety and stress, kinesiophobia, pain self-efficacy, and catastrophic pain, neurophysiology of pain, beliefs about fear avoidance and the presence of central sensitivity. Accordingly, these variables will be measured 2, 4, and 12 months after the conclusion of the intervention.interventions will be performed in Kharazmi University Health Centre.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria targets individuals aged 18 to 65 with a history of nonspecific low back pain.
Exclusion criteria individuals who have had spinal surgery in the past 12 months or report serious pathological signs and symptoms are excluded from this study.
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Intervention groups
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This study consists of three groups, including the control group, the patient-led goal setting group with pain neuroscience education, and the patient-led goal setting group with Manual therapy.
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Main outcome variables
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There is a difference between a patient-led goal-setting approach with patient leadership combined with pain neuroscience education or manual therapy on pain intensity in people with chronic low back pain.
General information
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Reason for update
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It is respectfully requested that an update be made regarding the editing of the sample size due to the necessary corrections on the power values of the test and the effect size of the main research variables.
The sample size was calculated based on the following process:
Considering a repeated measure ANOVA test using effect size η=0.25, confidence level α=0.05, expected power 95%, number of groups 3, and by performing 4 measurement stages of the test Therefore, the total number of required samples was estimated to be 45 people (and in other words, 15 people in each group), the mentioned calculations were done using G*Power version 3.1.9.2 software (Faul, Erdfelder et al. 2007).
Sincerely, Soheili
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210927052616N1
Registration date:
2021-11-03, 1400/08/12
Registration timing:
registered_while_recruiting
Last update:
2023-04-12, 1402/01/23
Update count:
2
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Registration date
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2021-11-03, 1400/08/12
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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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2021-10-22, 1400/07/30
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Expected recruitment end date
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2022-02-19, 1400/11/30
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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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Comparison the effect of patient-led goal setting with pain neuroscience education and Manual therapy in Patients with chronic low back pain.
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Public title
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Evaluation of the effect of patient-led goal-setting approach in combination with pain neuroscience training or manual therapy in patients with chronic low back pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having a history of nonspecific low back pain
Minimum duration of low back pain is 3 months
They reported pain intensity with 4 out of 11 points in the NRS questionnaire and at least 20 points in the QBPDS.
Exclusion criteria:
Spinal surgery report in the last 12 months
Severe osteoporosis
Signs and symptoms reported from serious pathology
Spondyloarthritis
Spondylolisthesis
Spinal canal stenosis
Traumatic spinal cord injury such as a fracture or car accident
Spinal dislocation
Spinal cord metastasis
Has symptoms of Cauda Equina syndrome
Structural scoliosis
Pregnancy
History of seizures, epilepsy, stroke or head injuries
Taking medications for patients with mental health problems
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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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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Following the baseline examination, by using the method shown on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants will be randomly assigned into the patient-led goal-setting approach group In combination with pain neuroscience education, the patient-led goal-setting approach group will be combined with manual therapy. Simple randomization will be used. Concealed allocation is performed using a computer-generated block randomized table of numbers (1 for patient-led goal-setting approach group In combination with pain neuroscience education and 2 for the patient-led goal-setting approach group will be combined with manual therapy) created before the start of data collection by a researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelopes. Another researcher, blind to the baseline examination, open an envelope and process with treatment according to the group assignment. An independent assessor who is not known about the study’s hypothesis and methods and is blind to the treatment group, assess the outcome measures before the interventions, 2 months after treatment, and 4 and 12 months after the end of the intervention, each time measured.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the outcome assessor was blinded of the process of randomization and division of individuals into two experimental and control groups.
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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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2021-08-21, 1400/05/30
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Ethics committee reference number
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IR.SSRC.REC.1400.084
Health conditions studied
1
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Description of health condition studied
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chronic low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Numerical Rating Scale
2
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Description
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Kinesophobia
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Tampa Scale For Kinesiophobia
3
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Description
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Fear Avoidance Beliefs
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Fear Avoidance Beliefs Questionnare
4
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Description
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Disability
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Qubec Back Pain Disability Scale
5
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Description
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Quality Of Life
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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SF_36 Scale
6
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Description
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Anxiety
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Depression Anxiety Stress Scale
7
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Description
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Depression
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Depression Anxiety Stress Scale
8
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Description
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Stress
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Depression Anxiety Stress Scale
9
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Description
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Pain Self-efficacy
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Pain Self-Efficacy Questionnare
10
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Description
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Central Sensitivity Inventory
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Central Sensitization Inventory
11
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Description
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Catastrophic pain
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Timepoint
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First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions
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Method of measurement
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Pain Catastrophizing Scale
Intervention groups
1
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Description
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Intervention group: patient-led goal setting group with Manual therapy. The goal-setting approach will be conducted over the course of 2 months through a one-hour face-to-face session followed by 4 sessions of 15 to 30 minutes over 2 weeks. Subsequently, two 30-minute sessions are performed with an interval of one month. Furthermore, twelve months after initiating the research the final session is performed and the results are collected. In this approach, the author has employed the SMART model which features measurable and achievable goal-setting processes that are specific to a time frame. In the aforementioned model, the researcher is trained in patient-led goal setting, takes the low back pain history of the patient into consideration, and engages in conversation regarding the consequences of their ailment. Moreover, the patient is asked to prioritize the problems based of their preferences. Afterward, strategies are considered based on evidence-based guidelines and the participant sets goals and chooses strategies to implement individually in between sessions. The participants will record their goals, progress, and obstacles and strategies to overcome the obstacles in their notebooks. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of 60 minutes over 6 weeks. For manual treatment, soft tissue mobilization techniques, muscle energy techniques, and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral, and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. The participant is asked to gently contract these muscles for 8 seconds with 30% of maximum contraction. This practice is repeated after each rest. The assessment of Joint mobilization is based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, and Piedallu Sign.
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Category
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Other
2
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Description
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Intervention group: patient-led goal setting group with Manual therapy.The goal-setting approach will be done with patient leadership over 2 months, which includes 5 face-to-face sessions, with the first session lasting one hour and the other four sessions lasting 15 to 30 minutes over two weeks. After that, two follow-up sessions (duration 30 minutes) are performed with an interval of one month. Also, one session is performed after 12 months after the first session and finally the results are collected. To perform this approach, a model called SMART is used, which includes a special process for goal setting that is measurable, achievable and related to a specific time return. In this model, the researcher is trained in setting goals by the patient, history of low back pain Considers the participant and talks about the problems caused by low back pain. Ask the participant to prioritize these problems based on what they want to focus on. Strategies are then discussed based on evidence-based guidelines, and the participant sets specific goals and strategies for the participants to work independently between sessions. They record what they agree to achieve in their workbook. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of treatment for 6 weeks and three times a week, each session lasting 60 minutes. For manual treatment, soft tissue mobilization techniques, muscle energy techniques and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. We ask the participant to gently contract these muscles for 8 seconds with 30% of maximum contraction. This movement is repeated after each rest. Joint mobilization is assessed based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, Piedallu Sign.
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Category
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Other
3
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Description
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Control group: Without receiving any intervention
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Category
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Other
1
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Sponsor
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Grant name
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Kharazmi University
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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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Kharazmi University
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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