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Recruiting NCT06283199

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.

Observational Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Musculoskeletal Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Difference in pain level [Time frame: one month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Rizzoli — Bologna
Switzerland · 1 center
  • EOC - Orthopaedics and Traumatology Service — Lugano

Identifiers

NCT: NCT06283199 · ORL-ORT-025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗