Musculoskeletal PainNCT06283199
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.
An observational study of Musculoskeletal Pain, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 1,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Apr 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna
Alessandro Di Martino, MD, 0039 051 6366567, alessandro.dimartino@ior.it
Switzerland1 site, 1 recruiting
- Recruiting
EOC - Orthopaedics and Traumatology Service
Lugano, 6900
Christian Candrian, Prof.Dr.med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
About this study
Official title: The Importance of Ecological Momentary Assessment to Capture the Whole Patient's Symptoms Experience in Musculo-skeletal Conditions
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
- Medical subject headings
- Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start6 Apr 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283199
- Sponsor's protocol ID
- ORL-ORT-025
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Ecological Momentary Assessment to Capture the Whole Patient's Symptoms Experience in Musculo-skeletal Conditions
- ClinicalTrials.gov ID
- NCT06283199
- Acronym / sponsor ID
- ORL-ORT-025
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Candrian, MD (00419117029, RicercaOrtopedia.ORL@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain level (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.