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Clinical Trials/NCT05769998
NCT05769998
Recruiting
Not Applicable

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

Istituto Auxologico Italiano1 site in 1 country210 target enrollmentJune 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Istituto Auxologico Italiano
Enrollment
210
Locations
1
Primary Endpoint
Number of days for pain disappearance
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
June 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Inability to provide informed consent

Outcomes

Primary Outcomes

Number of days for pain disappearance

Time Frame: 6 months

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

Secondary Outcomes

  • Presence of chronic pain(6 months)
  • Pain intensity(6 months)
  • Physical and Mental Quality of Life(6 months)
  • Knee pain, stiffness and physical function(6 months)

Study Sites (1)

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