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The effect of pain science education and graded sensorimotor relearning compared to usual physiotherapy in patients with chronic non-specific low back pain – a superiority trial

The effect of pain science education and graded sensorimotor relearning compared to usual physiotherapy in patients with chronic non-specific low back pain – a superiority trial - RESOLVE Swiss

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039237
Enrollment
220
Registered
2026-02-04
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic (>3 months), non-specific low back pain

Interventions

Group 1: The intervention group will receive a physiotherapy treatment according to the RESOLVE approach. The RESOLVE approach consists of three components: Pain Science Education, graded sensory retr

Sponsors

ZHAW Zürcher Hochschule für Angewandte Wissenschaften
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Non-specific low back pain persisting for at least 3 months - Score of = 7 points on the Roland Morris Disability Questionnaire (RMDQ) - Sufficient knowledge of German (read, understand, speak) to follow study procedures and fill out the questionnaires - Access to the internet and willingness to use private device (Smartphone, Tablet or Personal Computer) - Have someone available to assist with home training For fMRI subproject: - Being able to lie on the back for 1 hour

Exclusion criteria

Exclusion criteria: - Evidence of specific spinal pathology (such as malignancy, fracture, infection, or inflammatory joint or bone disease) - Presence of radiculopathy - Being pregnant or less than six months postpartum (self-reported) - Having a coexisting major medical disease that poses a relative or absolute contraindication to general exercise - Having undergone spinal surgery within the preceding 12 months - Having received an intra-articular or perineural steroid injection on the lumbar spine within the previous three month - Inability to follow the procedures of the study, e.g. due to language problems, predominant severe somatic or mental illness or insufficient psycho-intellectual abilities - Open legal dispute with insurance companies related to back pain For fMRI subproject: - MR contraindications - Pregnancy - Suffering from claustrophobia (self reported)

Design outcomes

Primary

MeasureTime frame
Low back pain related disability measured by Roland Morris Disability Questionnaire 18 weeks after baseline-measurement by means of an online questionnaire.

Secondary

MeasureTime frame
- Pain intensity (Numeric rating scale) - Functional disability (Patient Specific Functional Scale) - Tactile acuity of the lower back (Two-point discrimination, Point-to-point test) - Movement control of the lumbar spine - Medication intake - Treatment adherence - Workplace absence due to LBP (Work Productivity and Activity Impairment) - Cost-effectiveness (QALY’s and ICER’s) - Pain knowledge and attitudes (Neurophysiology of Pain Questionnaire, Back Pain Attitudes Questionnaire and Pain Self-Efficacy Questionnaire) - Psychological measures (Depression Anxiety and Stress Scale, Tampa Scale of Kinesiophobia) - Quality of Life (EQ-5D-5L) - Sleep (Insomnia Severity Index) - Body awareness (FreBAQ) - Treatment expectation and satisfaction (Expectation of treatment scale, perceived improvement, satisfaction with care and treatment) - Goal achievement (Goal attainment Scale) - Epistemic Beliefs (OLEQ) - Additional self-developed Likert-scale items for motivation, engagement, emotions All outcomes are assessed pre- and post-treatment (week 18), and all self-reported questionnaires are reassessed at week 26 and week 52 after baseline-measurements. For fMRI Subproject - BOLD responses in sensorimotor cortices induced by vibrotactile stimulation of the back across the thoracolumbar axis - BOLD whole-brain responses during rs-fMRI The outcomes are assessed at baseline and post-treatment.

Countries

Switzerland

Contacts

Public ContactChrista Wachter

ZHAW Zürcher Hochschule für Angewandte Wissenschaften

resolve.gesundheit@zhaw.ch+41 58 934 64 89

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026