NCT03910023

Non-pharmacological Treatment for Chronic Back Pain

Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Usual care comporting a home-exercise program (UCHE)	The UCHE intervention will correspond to current practice (including the continuation of previous treatments, if applicable) as decided by the attending physician. The patient will also be provided with a practical guide on how to manage back pain (the "back book"), including a recommended home exercise program.
OTHER	Spa therapy	the spa-therapy intervention consists of 18 consecutive days of spa-therapy (excepting Sundays), that must occur with 60 days of randomisation. The latter will combine mineral water with physical and hydrotherapeutic treatments, including massages, heat and water exercises.

Timeline

• Start date: 2019-06-15
• Primary completion: 2021-12-15
• Completion: 2022-06-15
• First posted: 2019-04-10
• Last updated: 2019-11-07

Locations

1 site across 1 country: France