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.

The Importance of Ecological Momentary Assessment to Capture the Whole Patient's Symptoms Experience in Musculo-skeletal Conditions

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Pain

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Christian Candrian, MD; Phone Number: 00419117029; Email: RicercaOrtopedia.ORL@eoc.ch

Study Locations

• Italy
  • Bologna, Italy
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Alessandro Di Martino, MD; Phone Number: 0039 051 6366567; Email: alessandro.dimartino@ior.it
• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • EOC - Orthopaedics and Traumatology Service
    • Contact: Christian Candrian, Prof.Dr.med; Phone Number: +41 (0) 91 811 61 23; Email: christian.candrian@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with musculoskeletal chronic pain with a clinical and imaging diagnosis of an orthopaedic disease such as knee osteoarthritis, hip osteoarthritis, shoulder osteoarthritis, ankle osteoarthritis, rizoathrosis, meniscectomy treatment, rotator cuff tendinopathy, low-back pain, Achille tendinopathy, patellar tendinopathy,and tennis elbow.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain
• Other Study ID Numbers: ORL-ORT-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No