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Clinical study

Run at Jessa Hospital in Hasselt, Belgium, from June 2024 to June 2025, with adults living with chronic non-specific low back pain.

Study design

Type
Prospective, randomised, controlled pilot study
Site
Jessa Hospital, Hasselt (Belgium)
Period
June 2024 – June 2025
Intervention
15 minutes of LumbaCure® added to the standard rehabilitation programme (back school)
Control group
15 minutes of additional exercise
Registration
ClinicalTrials.gov NCT06662032 ↗

How to read these results

Exploratory pilot study, not yet published in a peer-reviewed journal. The primary endpoint (change in ODI at visit 2) did not reach statistical significance: p = 0.101. These descriptive responder comparisons do not establish definitive efficacy.

Everyday function · visit 2ODI: functional disability. Relative improvement of at least 25%
LumbaCure®
LumbaCure®: 43.5%
Control
Control: 10%
Pain · visit 5Relative improvement of at least 25%
LumbaCure®
LumbaCure®: 77.8%
Control
Control: 37.5%
Pain catastrophising · visit 4PCS: negative thoughts about pain. Improvement of at least 7 points
LumbaCure®
LumbaCure®: 65%
Control
Control: 21.1%

V2, V4 and V5 refer to protocol visits 2, 4 and 5. Each threshold defines the improvement required to be counted as a responder.

Source: LumbaCure2302 clinical investigation report, version 1.2, 14/08/2025. Exploratory pilot study; results not yet published in a peer-reviewed journal.

  • ODI (disability)
  • Pain (NRS)
  • PSFS
  • Kinesiophobia (TSK-17)
  • Catastrophising (PCS)
  • Quality of life (EQ-5D-5L and VAS)
  • Participant satisfaction

  • A feeling of release in the pelvis
  • Improved flexibility
  • Reduced pain
  • Muscle relaxation
  • A sense of well-being
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