Video-Based Education Versus In-Person Education in Patients Undergoing Arthroscopic Partial Meniscectomy (NI-RCT)

February 3, 2026 updated by: Istituto Clinico Humanitas

Effectiveness of a Video-Based Educational Intervention Compared With In-Person Education on Psychosocial and Functional Outcomes in Patients Undergoing Arthroscopic Partial Meniscectomy: A Noninferiority Randomized Controlled Trial

The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Secondary aims are to explore the potential superiority of the video-based program compared to in-person instructions in reducing disability and kinesiophobia in the same patient population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Milan, Italy
      • Rozzano, Milan, Italy, Italy, 20089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients scheduled for arthroscopic partial meniscectomy (medial or lateral meniscus) performed in a day-hospital setting.
  • Traumatic or degenerative meniscal tears.
  • Treatment at the Hip and Knee Orthopedic Unit of the Humanitas Clinical Institute.
  • Age ≥ 18 years.
  • Access to adequate video support.
  • Sufficient proficiency in the Italian language.

Exclusion Criteria

  • Previous surgery on either knee within the past 5 years.
  • Significant postoperative hematoma requiring aspiration.
  • Neurological conditions potentially affecting functional or motor recovery.
  • Musculoskeletal conditions potentially affecting functional or motor recovery.
  • Rheumatologic conditions potentially affecting functional or motor recovery.
  • Internal medicine conditions potentially affecting functional or motor recovery.
  • Oncological conditions potentially affecting functional or motor recovery.
  • Cognitive or psychiatric disorders (Mini-Mental State Examination ≤ 21).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video-based group
Subjects assigned to this group will be asked to watch educational video within 5 days before surgery and to performe exercises shown in the video during the 2 weeks after surgery.
Behavioral: Video-based education
The video-based education was sent to patients within 5-day before surgery and consists of instructions to follow after surgery on wight-baring on the operated limb, advice to reduce swelling and movements tallowed to be performed. Exercises to perform in the 2 weeks after surgery are shown.
Active Comparator: Control group
Subjects assigned to this group will be instructed in-person by a physiotherapist on educational advice and exercises to perform during the 2 weeks after surgery.
Behavioral: Usual Care
Immediately after the surgery in day-hospital setting, a physiotherapist provided in-person instructions to patients assigned to control group. Instructions consists of the same educational content of the video-based group and the same exercises to perform in 2-weeks after surgery are shown and provided on a written spreadsheet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: From enrolment to the 6 weeks after surgery
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
From enrolment to the 6 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: From enrolment to the 3 weeks after surgery
The WOMAC evaluates knee pain, stiffness, and physical function, with score ranging from 0 to 96 and higher scores reflecting greater pain and functional impairment.
From enrolment to the 3 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
Time Frame: From enrolment to the 3 weeks after surgery
The TSK measures fear of movement and re-injury related to pain, with score ranging from 17 to 68 and higher scores indicating greater levels of kinesiophobia.
From enrolment to the 3 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: From enrolment to the 6 weeks after surgery
The WOMAC evaluates knee pain, stiffness, and physical function, with score ranging from 0 to 96 and higher scores reflecting greater pain and functional impairment.
From enrolment to the 6 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
Time Frame: From enrolment to the 6 weeks after surgery
The TSK measures fear of movement and re-injury related to pain, with score ranging from 17 to 68 and higher scores indicating greater levels of kinesiophobia.
From enrolment to the 6 weeks after surgery
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: From enrolment to the 3 weeks after surgery
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
From enrolment to the 3 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLF23/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets analyzed in this study are available on request from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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