A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial

Table 1 Study schedule of enrolment, follow-up, and assessments

Name of the visit	Eligibility screen	Enrolment	Follow-up			Phone calls
Temporality	D0–3W	D0	M3	M6	M9	D7	M1	M2	M3+7D	M4	M5	M7	M8
Time window for the visit	± 2W		[− 1W/+ 2W]			±2D	± 1W		±2D	± 1W
Location of the visit	By phone	Pain center
Information	✓	✓
Informed consent		✓
Clinical examination^a		✓	✓	✓	✓
Urine HCG if necessary		✓
Questionnaires^b		✓	✓	✓	✓
Randomization		✓
Collection of adverse events			✓	✓	✓	✓I	✓I	✓I	✓D	✓D	✓D	✓ID	✓ID
Personalized coaching^c		✓I	✓D			✓I	✓I	✓I	✓D	✓D	✓D
Reminder to complete the follow-up booklet							✓D	✓D		✓I	✓I	✓ ID	✓ ID

M month, W week, D day
^aClinical examination: height, weight, PAS, PAD, and pain on VAS
^bQuestionnaires: FIQ/PSQI/HAD/IMF20/EQ 5D-5L/GPAC/PGIC and CGIC (not at D0)
^cPersonalized coaching: in each box, it is specified for which group(s) it is realized. I Immediate solution, D Delayed solution

ISSN: 1745-6215