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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06283199
Other study ID # ORL-ORT-025
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2021
Est. completion date December 31, 2027

Study information

Verified date February 2024
Source Ente Ospedaliero Cantonale, Bellinzona
Contact Christian Candrian, MD
Phone 00419117029
Email RicercaOrtopedia.ORL@eoc.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months. After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Symptomatic patients - Patients able to give informed consent and to follow the protocol of the study (i.e. able to use a smartphone) - Patients >18 years - BMI <35 and >18.5 - Patients with a smartphone with Android or iOS as operative systems Exclusion Criteria: - Patients unable to follow the protocol of the study (i.e. unable to use a smartphone, not owning a smartphone or unwilling to download or use the application) - Patients with a diagnosis of a musculoskeletal injury but without symptoms - Patients without a radiological examination confirming the diagnosis of musculoskeletal disease - Patients with planned surgery in the following 60 days - Pregnant or lactating woman - Patients with other diseases causing pain in the involved joint (e.g. rheumatoid arthritis or other rheumatologic diseases). - Surgical treatment in the last year and intra-articular injection in the last 6 months

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Rizzoli Bologna
Switzerland EOC - Orthopaedics and Traumatology Service Lugano

Sponsors (1)

Lead Sponsor Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in pain level difference between the level of pain collected within the first month of mobile application and the level of pain reported through a retrospective recall-based assessment on the 0-10 Numerical Rating Scale one month
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