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

Knee Osteoarthritis Clinical Trial

— NOPAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769998
• Other study ID #: 03M902
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Acceptance and Commitment-based treatment
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.

Other:
• Treatment as usual
Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.

Locations

Country	Name	City	State
Italy	Auxologico Mosè Bianchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of chronic pain	WOMAC pain subscale >4	6 months
Secondary	Pain intensity	Pain intensity as measured by a 0-10 Numeric Rating Scale	6 months
Secondary	Knee pain, stiffness and physical function	Subscales of the WOMAC questionnaire	6 months
Secondary	Physical and Mental Quality of Life	Physical and Mental component scores on the SF-12 questionnaire	6 months