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

I

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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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