Non-pharmacological Treatment for Chronic Back Pain

  • STATUS
    Recruiting
  • End date
    Jun 15, 2022
  • participants needed
    358
  • sponsor
    Association Francaise pour la Recherche Thermale
Updated on 23 January 2021
chronic pain
back pain

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.

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.

Details
Condition Low Back Pain, Back Pain, Chronic Back Pain, Lower Back Pain, lumbago
Treatment SPA Therapy, Usual care comporting a home-exercise program (UCHE)
Clinical Study IdentifierNCT03910023
SponsorAssociation Francaise pour la Recherche Thermale
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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