Non-pharmacological Treatment for Chronic Back Pain (LOMBATHERM)

Association Francaise pour la Recherche Thermale

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Spa therapy; Other: Usual care comporting a home-exercise program (UCHE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03910023

2018-A02801-54

Details and patient eligibility

About

The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.

Full description

Secondarily, the study will also (i) evaluate the therapeutic effects specific to each spa-centre, (ii) specifically describe effects among subjects who are currently engaged in a professional activity, (iii) evaluate treatment tolerance as well as (iv) per-patient health resource use and associated costs.

Enrollment: 358 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion 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.
• Patient presenting with a current pain intensity on a visual analogue scale (VAS) > or = 40 mm.
• The patient has signed the informed consent
• The patient is a beneficiary of a social security programme [national health insurance]

Exclusion criteria

• Patients with secondary low back pain
• Patients with severe depression, psychosis
• Patients who have already had a spa treatment in the previous 6 months
• Patients with a contraindication for spa treatment
• Patients with a professional activity related to hydrotherapy (to avoid any conflict of interest)
• Patients with sciatic pain beyond the knee (sciatica being a non-indication for spa treatment)
• Other treatments that may interact according to the judgment of the investigator
• Patients who live more than 30 km away from the spa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

358 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group will perform home exercises alone

Treatment:

Other: Usual care comporting a home-exercise program (UCHE)

Spa group

Experimental group

Description:

The spa group will be proposed an additional spa treatment

Treatment:

Other: Spa therapy

Other: Usual care comporting a home-exercise program (UCHE)