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.

NCT06283199 | Recruiting

• 1 other identifier: ORL-ORT-025
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 2

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.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (2)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

EOC - Orthopaedics and Traumatology Service

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Candrian, MD

CONTACT

00419117029; RicercaOrtopedia.ORL@eoc.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: April 6, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); IT (1)