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.

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283199
• Other study ID #: ORL-ORT-025
• Status: Recruiting
• Start date: April 6, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Christian Candrian, MD
• Phone: 00419117029
• Email: RicercaOrtopedia.ORL[@]eoc.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna
Switzerland	EOC - Orthopaedics and Traumatology Service	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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