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

Ente Ospedaliero Cantonale, Bellinzona2 sites in 2 countries1,500 target enrollmentApril 6, 2021

ConditionsMusculoskeletal Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Musculoskeletal Pain
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Enrollment: 1500
Locations: 2
Primary Endpoint: Difference in pain level
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 6, 2021

End Date

December 31, 2027

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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