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Recruiting

NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference in pain level

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Candrian, MD

CONTACT

[email protected]

00419117029

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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