Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.

Recruiting

• Conditions: Musculoskeletal Pain

• Registration Number: NCT06283199
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in pain level	one month	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

Trial Locations

Locations (2)

EOC - Orthopaedics and Traumatology Service; 🇨🇭 Lugano, Switzerland

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy