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NCT05769998: NOPAIN

Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty

Status unknown NA Last updated 15 March 2023
What this trial tests

NA trial testing Acceptance and Commitment-based treatment in Knee Osteoarthritis in 210 participants. Status unknown.

Timeline
15 June 2021
Primary endpoint
15 March 2024
15 June 2024

Quick facts

Lead sponsorIstituto Auxologico Italiano
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment210
Start date15 June 2021
Primary completion15 March 2024
Estimated completion15 June 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Auxologico Italiano — full company profile →

Who can join

Adults 18 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Acceptance and commitment therapy for prevention of chronic pain after total knee arthroplasty.
    Giusti EM, Castelnuovo G, Manna C, Varallo G, et al · · 2026 · PMID 41128594 · DOI 10.1093/pm/pnaf145

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Istituto Auxologico Italiano trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05769998.

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