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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)

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acceptance and Commitment-based treatment
Treatment as usual
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Auxologico Mosè BianchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acceptance and Commitment-based treatment

Treatment as usual

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of days for pain disappearance
The first among five consecutive days with pain intensity <3 on a 0-10 Numeric Rating Scale

Secondary Outcome Measures

Presence of chronic pain
WOMAC pain subscale >4
Pain intensity
Pain intensity as measured by a 0-10 Numeric Rating Scale
Knee pain, stiffness and physical function
Subscales of the WOMAC questionnaire
Physical and Mental Quality of Life
Physical and Mental component scores on the SF-12 questionnaire

Full Information

First Posted
March 3, 2023
Last Updated
March 3, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05769998
Brief Title
Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
Acronym
NOPAIN
Official Title
Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment-based treatment
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment-based treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.
Primary Outcome Measure Information:
Title
Number of days for pain disappearance
Description
The first among five consecutive days with pain intensity <3 on a 0-10 Numeric Rating Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Presence of chronic pain
Description
WOMAC pain subscale >4
Time Frame
6 months
Title
Pain intensity
Description
Pain intensity as measured by a 0-10 Numeric Rating Scale
Time Frame
6 months
Title
Knee pain, stiffness and physical function
Description
Subscales of the WOMAC questionnaire
Time Frame
6 months
Title
Physical and Mental Quality of Life
Description
Physical and Mental component scores on the SF-12 questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Auxologico Mosè Bianchi
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuele Giusti, PhD
Phone
3498798942
Email
e.giusti@auxologico.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will be uploaded to an online repository
IPD Sharing Time Frame
The dataset will be made available upon completion
IPD Sharing Access Criteria
The dataset will be uploaded to an online repository

Learn more about this trial

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

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