NCT07358325

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 13, 2026

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Self-Efficacy Questionnaire (PSEQ)

    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 Outcomes (5)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    From enrolment to the 3 weeks after surgery

  • Tampa Scale of Kinesiophobia (TSK)

    From enrolment to the 3 weeks after surgery

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    From enrolment to the 6 weeks after surgery

  • Tampa Scale of Kinesiophobia (TSK)

    From enrolment to the 6 weeks after surgery

  • Pain Self-Efficacy Questionnaire (PSEQ)

    From enrolment to the 3 weeks after surgery

Study Arms (2)

Video-based group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Video-based group
Usual CareBEHAVIORAL

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy, 20089, Italy

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Locations