Knee OsteoarthritisNOPAINNCT05769998
Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
A study testing Acceptance and Commitment-based treatment and Treatment as usual in people with Knee Osteoarthritis, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Acceptance and Commitment-based treatment and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Auxologico Mosè Bianchi
Milan, 20149
Emanuele Giusti, PhD, 3498798942, e.giusti@auxologico.it
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Acceptance and Commitment-based treatment, Treatment as usual
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment-based treatmentBehavioural
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.
Treatment as usualOther
Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment-based treatment | Experimental | 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. Receives: Behavioral: Acceptance and Commitment-based treatment; Other: Treatment as usual |
| Treatment as usual | Other | Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days for pain disappearance
The first among five consecutive days with pain intensity <3 on a 0-10 Numeric Rating Scale
Measured: 6 months
Secondary outcomes (4)
Presence of chronic pain
WOMAC pain subscale >4
Measured: 6 months
Pain intensity
Pain intensity as measured by a 0-10 Numeric Rating Scale
Measured: 6 months
Knee pain, stiffness and physical function
Subscales of the WOMAC questionnaire
Measured: 6 months
Physical and Mental Quality of Life
Physical and Mental component scores on the SF-12 questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Jun 2021
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769998
- Sponsor's protocol ID
- 03M902
- Acronym
- NOPAIN
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be uploaded to an online repository
Publications
Giusti EM, Castelnuovo G, Manna C, Varallo G, Cattivelli R, Petrachi BV, Stramba-Badiale M, Spatola CAM. Acceptance and commitment therapy for prevention of chronic pain after total knee arthroplasty. Pain Med. 2026 Apr 1;27(4):385-392. doi: 10.1093/pm/pnaf145.
PubMed 41128594
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05769998
- Acronym / sponsor ID
- NOPAIN / 03M902
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment-based treatment | Experimental | Behavioral: Acceptance and Commitment-based treatment, Other: Treatment as usualAcceptance 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 as usual | Other | Other: Treatment as usualUsual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment-based treatmentThe 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. | Behavioural | Acceptance and Commitment-based treatment |
| Treatment as usualStandard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit. | Other | Acceptance and Commitment-based treatment, Treatment as usual |
Primary outcome
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
4 secondary outcomes
Presence of chronic pain
Time frame: 6 months
Pain intensity
Time frame: 6 months
Knee pain, stiffness and physical function
Time frame: 6 months
Physical and Mental Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 41128594Giusti EM, Castelnuovo G, Manna C, Varallo G, Cattivelli R, Petrachi BV, Stramba-Badiale M, Spatola CAM. Acceptance and commitment therapy for prevention of chronic pain after total knee arthroplasty. Pain Med. 2026 Apr 1;27(4):385-392. doi: 10.1093/pm/pnaf145.
- Individual participant dataSharing planned: Yes. The dataset will be uploaded to an online repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment-based treatment and Treatment as usual in people with Knee Osteoarthritis, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days for pain disappearance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.