NCT05769998

Brief Summary

Reducing the incidence of chronic post-surgical pain after Total Knee Arthroplasty (TKA) is paramount. NOPAIN, a technology-enhanced Acceptance and Commitment-based treatment, will be developed, tested and improved for this purpose. The feasibility of NOPAIN will be evaluated in a small sample of patients listed for TKA at the IRCCS Istituto Auxologico Italiano. Potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. The results of this study will be employed to improve the content of NOPAIN or for identification of criteria for patient selection. Finally, a randomized controlled clinical trial will be performed. Patients listed for TKA will be randomized to Treatment As Usual (TAU) or to NOPAIN+TAU. Primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Number of days for pain disappearance

    The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale

    6 months

Secondary Outcomes (4)

  • Presence of chronic pain

    6 months

  • Pain intensity

    6 months

  • Knee pain, stiffness and physical function

    6 months

  • Physical and Mental Quality of Life

    6 months

Study Arms (2)

Acceptance and Commitment-based treatment

EXPERIMENTAL

Acceptance and Commitment-based (ACT) treatment including a face-to-face component administered during the patient stay in the rehabilitation unit and an online component including 4 ACT modules with an estimated duration of one month. The treatment is added to the Treatment as Usual provided in the rehabilitation unit.

Behavioral: Acceptance and Commitment-based treatmentOther: Treatment as usual

Treatment as usual

OTHER

Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project.

Other: Treatment as usual

Interventions

Acceptance and Commitment-based treatmentBEHAVIORAL

The ACT-based group intervention includes four 1-hour group sessions over two weeks. The treatment manual was developed by the authors of this study following the ACT framework and adapting materials and resources from ACT-based treatments developed for other settings. The focus of the intervention is to provide patients with pain education specific for patients who underwent TKA and to promote psychological flexibility. Each session employs experiential exercises, including mindfulness meditation, and metaphors addressing the core components of ACT.

Acceptance and Commitment-based treatment
Treatment as usualOTHER

Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.

Acceptance and Commitment-based treatmentTreatment as usual

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having an age between 18 and 80 years
  • having a diagnosis of OA as determined by medical record review
  • having undergone a Total Knee Arthroplasty

You may not qualify if:

  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auxologico Mosè Bianchi

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

June 15, 2021

Primary Completion

March 15, 2024

Study Completion

June 15, 2024

Last Updated

March 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

The dataset will be uploaded to an online repository

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The dataset will be made available upon completion
Access Criteria
The dataset will be uploaded to an online repository

Locations

IT(1)