Effect of a 6-month supply of afferent-stimulating insoles on paraspinal muscle tone, subjective pain perception, and health-related quality of life in patients with chronic non-specific low back pain: a randomized controlled trial

Effect of a 6-month supply of afferent-stimulating insoles on paraspinal muscle tone, subjective pain perception, and health-related quality of life in patients with chronic non-specific low back pain: a randomized controlled trial - DORSO-RELAX study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038213

Enrollment

Registered

2025-10-30

Start date

2023-06-09

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

M54.5

Interventions

Group 1: Intervention group (afferent-stimulating insoles): Participants in this group received individually fitted afferent-stimulating (sensorimotor) insoles designed to modulate neuromuscular activ

Eligibility

Sex/Gender

All

Age

22 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female and male patients with chronic non-specific low back pain (= 12 weeks duration) Age: 22–65 years Sufficient walking ability (= 30 minutes per day) Adequate understanding of the German language Legal capacity and ability to understand the nature and implications of the clinical study

Exclusion criteria

Exclusion criteria: Central neurological diseases or disorders Peripheral neuropathies Physiotherapeutic, osteopathic, or other treatments during the study intervention that could influence muscle tone Drug dependence and/or alcohol abuse Chronic muscular diseases (e.g., myasthenia, muscular dystrophy) Obesity (BMI = 35) Previous treatment with orthopedic or proprioceptive insoles

Design outcomes

Primary

Measure	Time frame
Change in paraspinal muscle activity (µV) over a 6-month period, measured by surface electromyography (sEMG) at the bilateral L5 level.	—

Secondary

Measure	Time frame
Change in subjective pain intensity (Numeric Rating Scale, NRS); Change in health-related quality of life (SF-36 – Physical and Mental Component Summary Scores)	—

Countries

Germany

Contacts

Public ContactRoland Lange

MEDICUM Rhein-Ahr-EIfel GmbH

r.lange@fokus-leistungsmedizin.de+4926413084541

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026