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(2 weekly /month) |
(follow-up 1st month) |
(2nd month) |
(follow-up 3rd month) |
(every 45 days) |
(follow-up 6th month) |
(every 2 months) |
End of follow-up (1 year) |
Patients
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Patient’s evaluation and collection of the relevant data |
√ |
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Inclusion/Exclusion criteria |
√ |
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Explanation of the objectives of the procedure and how it works |
√ |
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Informed consent |
√ |
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Randomization and blinding |
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√ |
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Expectation of acupuncture |
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√ |
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√ |
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√ |
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√ |
Treatment
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Electro-acupuncture (EA) |
|
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
Sham acupuncture (SA) |
|
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
√ |
Outcomes
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Visual analogue scale (VAS) |
√ |
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√ |
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√ |
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√ |
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√ |
McMaster Universities Osteoarthritis Index (WOMAC) |
√ |
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√ |
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√ |
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√ |
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√ |
Medication use |
√ |
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√ |
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√ |
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√ |
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√ |
Goldberg Anxiety and Depression Scale |
√ |
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√ |
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√ |
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√ |
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√ |
Short Form Health Survey (SF-36v2) |
√ |
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√ |
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√ |
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√ |
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√ |
Blood sample collection |
√ |
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√ |
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√ |
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√ |
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√ |
Trial evaluation
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Adverse event |
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√ |
|
√ |
|
√ |
|
√ |
Outcome assessment |
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√ |
Reasons of drop-outs or withdrawals |
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√ |
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√ |
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√ |
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√ |
Satisfaction and expectations Survey |
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√ |