Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM’ study, a multicentric randomised controlled trial

Table 3 The LOMBATHERM’ protocol schedule for enrolment, interventions, assessments, and visits for participants

Visit/event:	Enrolment visit^a		Intervention period	Follow-up visits^b
Visit/event:	Baseline	Allocation	Intervention period	1	2	3
Target chronology (days, weeks, months)	D0	D0 (after baseline)	D1–D60	M1^c (D28–D60)	M6 ± 4 W	M12 ± 4 W
Enrolment and allocation
First study presentation and consent 1	✓
Randomisation		✓
For those patients randonmised to the experimental arm, presentation of additional spa-treatment and consent 2		✓
Interventions
Explanation about low back pain and home exercise training for all patients	✓
Daily exercises at home using the “back book” for all patients^d			Throughout intervention and follow-up periods
Eighteen consecutive days of spa-therapy (except Sundays) for patients in the experimental arm			✓
Observance
Home exercise observance				✓	✓	✓
Spa therapy observance (experimental arm only)			✓
Harms
Tolerance: adverse event characterisation and reporting			Throughout intervention and follow-up periods
Assessments
Demographics and disease history^e	✓
Visual analogue scale for low back pain	✓			✓	✓	✓
The Rolland and Morris (RMDQ) scale	✓			✓	✓	✓
The FABQ	✓			✓	✓	✓
The EQ-5D-5L questionnaire	✓			✓	✓	✓
Patient Acceptable Symptom State	✓			✓	✓	✓
Global opinions on state of health^f	✓			✓	✓	✓
Drug consumption in the past 72 h	✓			✓	✓	✓
Health resource use since last visit^g				✓	✓	✓
Cost of care^h						✓
Blinding success
Guess-the-group question for evaluators						✓

D day, M month, W week, FABQ Fear, Avoidance, Belief Questionnaire, EQ-5D-5L Euroqol Group 5 dimension, 5 level questionnaire
^aEnrolment visits are performed by recruiting investigators, who are not the same as evaluating investigators
^bFollow-up visits are performed by evaluating investigators, who are not the same as recruiting investigators
^cOr just after the end of spa therapy, if applicable
^dThe patient will also be provided with a practical guide on how to manage back pain (the “back book”), including a recommended home exercise programme [15]
^eAge, sex, duration of current episode of low back pain, signs of spread of osteoarthritis, pain spreading, history of lumbar surgery, need for frequent position changes, bad mood and irritability, sleep disorders due to back pain
^fSemi quantitative scales that reflect (1) the patient’s and, separately, (2) the physician’s overall opinion concerning the patient’s state of health
^gResource use including infiltrations, hospitalizations, physical treatments (massages, traction, physical therapy) and medical imaging of the lumber spine will be tracked
^hCosts will be estimated using resource-use data gathered during visits and the French National Cost Scale. Indemnities related to days of sick leave will be included in cost estimates

ISSN: 1745-6215