Table 1 Planned visit schedule for treatment and follow-up, indicating visit number and frequency
Visits | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
0 | 1st | 2nd -7th | 8th | 9th | 10th | 11th | 12th | 13th-14th | 15th | |
(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 | ||||||||||
Patient’s evaluation and collection of the relevant data | √ | |||||||||
Inclusion/Exclusion criteria | √ | |||||||||
Explanation of the objectives of the procedure and how it works | √ | |||||||||
Informed consent | √ | |||||||||
Randomization and blinding | √ | |||||||||
Expectation of acupuncture | √ | √ | √ | √ | ||||||
Treatment | ||||||||||
Electro-acupuncture (EA) | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
Sham acupuncture (SA) | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
Outcomes | ||||||||||
Visual analogue scale (VAS) | √ | √ | √ | √ | √ | |||||
McMaster Universities Osteoarthritis Index (WOMAC) | √ | √ | √ | √ | √ | |||||
Medication use | √ | √ | √ | √ | √ | |||||
Goldberg Anxiety and Depression Scale | √ | √ | √ | √ | √ | |||||
Short Form Health Survey (SF-36v2) | √ | √ | √ | √ | √ | |||||
Blood sample collection | √ | √ | √ | √ | √ | |||||
Trial evaluation | ||||||||||
Adverse event | √ | √ | √ | √ | ||||||
Outcome assessment | √ | |||||||||
Reasons of drop-outs or withdrawals | √ | √ | √ | √ | ||||||
Satisfaction and expectations Survey | √ | |||||||||