Effects of balneological therapies on pain, function, microcirculation and molecular markers in finger osteoarthritis (ELVIS study): a monocentric, randomized, double-blind, placebo-controlled study

Effects of balneological therapies on pain, function, microcirculation and molecular markers in finger osteoarthritis (ELVIS study): a monocentric, randomized, double-blind, placebo-controlled study - ELVIS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036326

Enrollment

Registered

2025-03-05

Start date

2023-01-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

patient with finger polyarthrosis

Interventions

Group 1: Patients with finger osteoarthritis Intervention: Immersion of the affected hand in 36°C warm thermal brine bath 12 (Bad Nauheim) for 20 minutes (group 1) - hand bath is covered and blinded G

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with bilateral painful hand osteoarthritis (HOA) must meet the 1990 American College of Rheumatology (ACR) classification criteria (Altman et al., 1990). Eligible patients must have a baseline pain level >30 mm on the Visual Analog Scale (VAS) (0 mm = no pain; 100 mm = worst pain) and radiographic evidence of hand osteoarthritis in posteroanterior X-ray projection, classified as Kellgren and Lawrence grade =2 (Kellgren & Lawrence, 1957).

Exclusion criteria

Exclusion criteria: Patients must not be undergoing analgesic therapy (NSAIDs/COX-2 inhibitors, metamizole, opioids), steroid or glucosamine medication, or have received physical therapy for hand osteoarthritis (HOA) in the 12 weeks prior to study participation. They must be hand-bath naïve, meaning they have not previously undergone hand baths. Patients with (secondary) HOA due to inflammatory rheumatic diseases, active HOA (acute inflammation at study start), trauma, or open wounds are excluded. Additionally, patients with diabetes, vasoactive medication, trophic skin disorders, concomitant vascular disease, sensory deficits (polyneuropathy), or Raynaud’s disease are not eligible. Smokers are also excluded.

Design outcomes

Primary

Measure	Time frame
Pain of finger osteoarthritis on a numeric rating scale	—

Secondary

Measure	Time frame
- Grip strength using a vigorimeter - Impairment of hand function (Australian/Canadian Osteoarthritis Hand Index - AUSCAN) - Patient satisfaction (effectiveness and importance - Likert scale) - Changes in selected molecular markers: interleukin-1, vascular endothelial growth factor - VEGF and collagen-II	—

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Campus Kerckhoff der JLU-Giessen, Kerckhoff Klinik, Abt. Rheumatologie, klinische Immunologie, Osteologie und Physikalische Medizin

philipp.klemm@med.uni-giessen.de+49630329962101

Outcome results

None listed

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