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To verify the effectiveness and safety of therapy support software

To verify the effectiveness and safety of therapy support software - A single-center randomized parallel-group controlled trial to evaluate the efficacy and safety of software for continuing home exercise therapy in patients with osteoarthritis of the knee.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2032250447
Enrollment
30
Registered
2025-10-21
Start date
2025-10-21
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Osteoarthritis of the knee

Interventions

Implementation of exercise therapy (rehabilitation) at home.

Sponsors

Tanabe Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet the following criteria (1) to (8) will be eligible: (1) Outpatients aged 50 to under 80 years who complain of knee joint pain. Both male and female patients are eligible. (2) Patients who have received sufficient explanation using an information document, understood its content, and have provided written consent to participate in the clinical trial voluntarily. (3) Patients who are new to the medical institution. Previous visits are allowed, but patients should not have received treatment within the past 4 weeks. (4) The presence of asymmetry in symptoms is acceptable, but the side with more severe symptoms will be the target. The following should be confirmed, and the patient must meet at least one of the criteria: Morning stiffness lasting under 30 minutes Joint crepitus Tenderness at the joint line Bone thickening (osteophyte formation) No warmth in the joint (5) Patients whose radiographic examination (X-ray) during screening shows Kellgren-Lawrence grade II or higher. (6) Patients whose VAS (Visual Analog Scale) score during screening is 6.0 or lower and who are able to perform rehabilitation exercises. (7) Patients who agree not to use over-the-counter pain medications (topical or oral) other than those prescribed by the principal investigator during the clinical trial. (8) Patients who regularly use a smartphone and are capable of operating the application.

Exclusion criteria

Exclusion criteria: (1) Patients who received treatment for the knee joint at another medical institution within 4 weeks prior to obtaining consent, that is, patients who underwent exercise therapy or intra-articular injection in the knee within 4 weeks prior to obtaining consent. (2) Patients who have undergone or are scheduled to undergo surgical treatment of the knee within 6 months prior to obtaining consent. (3) Patients with pain in the affected area who are unable to perform rehabilitation exercises. (4) Patients requiring intra-articular injection of medication in the knee joint. (5) Patients requiring joint fluid aspiration. (6) Patients with conditions requiring continuous or intermittent administration of steroids. (7) Patients with a history of joint cartilage damage or destruction due to obvious trauma or pyogenic arthritis. (8) Patients diagnosed with rheumatoid arthritis, gout, pseudogout, or collagen disease. (9) Patients with severe heart failure. (10) Patients with severe liver dysfunction. (11) Patients with severe renal dysfunction.

Design outcomes

Primary

MeasureTime frame
Change from baseline at 12 weeks in JKOM (overall evaluation) (Test product app group vs. standard treatment group)

Contacts

Public ContactKikuno Dakeshita

CrossMed Co.,Ltd.

k.dakeshita@crossmed.jp+81-90-1427-4433

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026