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A multi-centered analysis on the effect of eHealth and usual care in IBD patients with peripheral artralgia

Conditions
Artralgia
joint complaints
10017969
10023213
Registration Number
NL-OMON43831
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
128
Inclusion Criteria

- Age of 18-70 years old
- IBD patients in clinical remission for at least 6 months (based on the HBI score < 4, fecal calprotectin < 150 µg/g and CRP < 3 mg/L) or endoscopic proven remission in the last 12 months
- Peripheral arthralgia for at least 3 months with a VAS score of at least 40 (out of 100).
- Written informed consent

Exclusion Criteria

- Joint complaints classified as SpA according to the ASAS criteria
- Only axial joint complaints
- Change of smoking habit during the study period

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary efficacy outcome is the average improvement of coping and quality<br /><br>of life in IBD patients with peripheral arthralgia interventions due to eHealth<br /><br>and usual care in IBD patients with arthralgia. The effects will be measured<br /><br>with VAS coping scores and SF-36 questionnaire. Additionally, the effect of<br /><br>eHealth and usual care on the average pain reduction will be measured with the<br /><br>VAS pain score.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The difference in the average reduction of pain intensity, improvement of<br /><br>coping and the impact of the complaints in daily life between IBD patients with<br /><br>arthralgia who undergo eHealth therapy in combination with usual therapy and<br /><br>IBD patients who undergo just usual care.</p><br>
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