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 2 Inclusion and exclusion criteria for participants

Inclusion criteria	Exclusion criteria
Adult patient presenting with chronic low back pain: usual pain of the lumbar region lasting for more than 3 months. This pain may radiate to the buttocks, iliac crest, and does not go past the knee [7]	Patients with specific low back pain
Patient presenting upon inclusion with a current pain intensity on a visual analogue scale (VAS) > or = 40 mm.	Patients with severe depression, psychosis
The patient has signed the informed consent form	Patients who have already had a spa treatment in the previous 6 months
Subject aged over 18 and under 80 (years)	Patients with a contraindication for spa treatment^a
The patient is a beneficiary of a social security programme (national health insurance)	Patients with a professional activity related to balneotherapy (to avoid any conflict of interest)
	Patients with cruralgia or sciatic pain beyond the knee
	Other treatments that may interact according to the investigator’s judgement
	Patients who live more than 30 km away from the spa^b

^a Immune deficiency, progressive heart disease, progressive neoplasia, infection, chronic bronchitis [14] or foreseeable intolerance to thermal care (intolerance to heat, baths, swimming pool, etc.)
^b It will not be convenient to make patients travel more than 60 km per day in their vehicle to deliver between 1 h and 1 h 30 min of outpatient care

ISSN: 1745-6215