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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Acceptance and Commitment-based treatment; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05769998

03M902

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Acceptance and Commitment-based treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment-based treatment

Other: Treatment as usual

Treatment as usual

Other group

Description:

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

Treatment:

Other: Treatment as usual