Possibility of the health app reducing the impact of pain on patients with axial spondyloarthritis in everyday life. (ESTABLISH study)

Possibility of the health app reducing the impact of pain on patients with axial spondyloarthritis in everyday life. (ESTABLISH study) - ESTABLISH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037509

Enrollment

250

Registered

2025-07-30

Start date

2023-06-30

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

M45.0

Interventions

Group 1: Group 1 Intervention: Patients with axial spondyloarthritis (axSpA) who continue to suffer from pain despite adequate anti-inflammatory medication are prescribed the electronic acceptance and

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Adult patients with axSpA diagnosed by a specialist - Onset of the disease =6 months - Pain score of =4 on a numerical rating scale of 0-10 (using either BASDAI question 2 or the pain NRS) - Stable pharmacological treatment - No signs of inflammatory activity - Patients who have given written informed consent

Exclusion criteria

Exclusion criteria: - Inability or unwillingness to sign the declaration of consent - Insufficient understanding of the German language - Unwilling or unable to use health apps - Planned changes to cs/b/ts-DMARD therapy or pain medication

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the change in the pain interference scale of the West Haven-Yale Multidimensional Pain Inventory (MPI-D) at month 3.	—

Secondary

Measure	Time frame
- Changes in pain (global pain on the NRS (0-10), back pain (BASDAI question 2), nocturnal back pain, inflammatory back pain (BASDAI questions 5 and 6) - Proportion of patients who have achieved PASS status - Change in disease activity (ASDAS, BASDAI) - Change in physical functioning: BASFI - Change in spinal mobility: BASMI - Mental health: HADS and MPI-D - Change in physical activity: mSQUASH - Change in quality of life (ASAS HI, FIQ, SF36) - Change in patient and physician global assessment - Number of patients who have achieved a strong improvement in the patient global impression of change	—

Measure

Time frame

- Changes in pain (global pain on the NRS (0-10), back pain (BASDAI question 2), nocturnal back pain, inflammatory back pain (BASDAI questions 5 and 6) - Proportion of patients who have achieved PASS status - Change in disease activity (ASDAS, BASDAI) - Change in physical functioning: BASFI - Change in spinal mobility: BASMI - Mental health: HADS and MPI-D - Change in physical activity: mSQUASH - Change in quality of life (ASAS HI, FIQ, SF36) - Change in patient and physician global assessment - Number of patients who have achieved a strong improvement in the patient global impression of change

—

Countries

Germany

Contacts

Public ContactUta Kiltz

Rheumazentrum Ruhrgebiet

Uta.Kiltz@elisabethgruppe.de+492325592131

Outcome results

None listed

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