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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

January 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID 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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