Knee Arthroplasty, TotalPsInTKANCT02988947
Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty
A study testing PNE+HyP in people with Knee Arthroplasty, Total, run by University of Minho at 1 site in Portugal.
Trial summary
The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- PNE+HyP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2018to 18 Dec 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned unilateral total knee arthroplasty due to gonarthrosis
- Giving consent to participate
Who cannot join
- Inability to write and read
- Cognitive deficit (assessed by MMSE)
- Revision TKA
- Bilateral TKA
- TKA for reasons other than gonarthrosis (fracture, malignancy or infection)
- Psychiatric or neurological deficit (e.g. Schizophrenia or Alzheimers')
Show all 9Show fewer
- Diagnosis of rheumatoid arthritis, Psoriatic arthritis, Systemic lupus erythematosus, Anquilosant spondylitis or other severe disease
- Contralateral hip or knee arthroplasty in the previous 6 months
- Planned contralateral hip or knee arthroplasty in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Psychological Intervention for the Control and Prevention of Pain and for Surgical Recovery in Patients Undergoing Total Knee Arthroplasty: a Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty
Read the detailed description
This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG), submitted to usual treatment and care.
After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and, afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement sessions. At 1 month post-surgery, the intervention group will be subdivided and participants will be randomly assigned to receive a reinforcement session or no intervention at this point. The psychological intervention sessions are based on the educative principles of Pain Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive coping strategies and psychological variables.
Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6 months post surgery; T5 - 12 months post intervention. Patients will fill in self report measures and perform physiological evaluation to analyse relevant bio-markers (salivary cortisol and α-amylase) that are related to stress levels and SNS functioning and translate the impact of psychological interventions on physiological parameters.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- PNE+HyP
- Keywords
- Knee Arthroplasty, Hypnosis, Pain Neuroscience Education, Pain, Catastrophizing, Optimism, Distress, Hope, Self-Efficacy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNE+HyPOther
This is a combined PNE and Hypnosis psychological intervention. PNE is a cognitive based approach that highlights the biopsychosocial model of pain and focuses on neurophysiological and neurobiological processes and pain representation. Hypnosis aims at promoting pain control, increasing positive coping strategies, and targeting positive psychological variables.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (PNE+HyP) | Experimental | Patients in this group will have 3 pre-surgical + 1 (or 2) reinforcement sessions in adition to standard TKA care. These interventions are based on Pain Neuroscience Education and Hypnosis and delivered according to standardized scripts. Receives: Other: PNE+HyP |
| Control Group | No intervention | No intervention / Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
Measured: 24h before surgery
Pain intensity 72h post-surgery as assessed by NRS
Measured: 72h post-surgery
Pain intensity 1 month post-surgery as assessed by NRS and WOMAC
Measured: 1 month post-surgery
Pain intensity 6 months post-surgery as assessed by NRS and WOMAC
Measured: 6 months post-surgery
Pain intensity 12 months post-surgery as assessed by NRS and WOMAC
Measured: 12 months post-surgery
Secondary outcomes (39)
Physical functioning post-intervention as assessed by WOMAC
Measured: 24h before surgery
Physical functioning 1 month post-surgery as assessed by WOMAC
Measured: 1 month post-surgery
Physical functioning 6 months post-surgery as assessed by WOMAC
Measured: 6 months post-surgery
Physical functioning 12 months post-surgery as assessed by WOMAC
Measured: 12 months post-surgery
Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)
Measured: 24h before surgery
Pain knowledge 1 month post-surgery as assessed by the NPQ
Measured: 1 month post-surgery
Pain knowledge 6 months post-surgery as assessed by NPQ
Measured: 6 months post-surgery
Pain knowledge 12 months post-surgery as assessed by NPQ
Measured: 12 months post-surgery
Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)
Measured: 24h before surgery
Emotional distress 1 month post-surgery as assessed by HADS
Measured: 1 month post-surgery
Emotional distress 6 months post-surgery as assessed by HADS
Measured: 6 months post-surgery
Emotional distress 12 months post-surgery as assessed by HADS
Measured: 12 months post-surgery
Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)
Measured: 24h before surgery
Optimism 1 month post-surgery as assessed by LOT
Measured: 1 month post-surgery
Optimism 6 months post-surgery as assessed by LOT-R
Measured: 6 months post-surgery
Optimism 12 months post-surgery as assessed LOT-R
Measured: 12 months post-surgery
Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)
Measured: 24h before surgery
Pain coping strategies 1 month post-surgery as assessed by CSQ
Measured: 1 month post-surgery
Pain coping strategies at 6 months post-surgery as assessed by CSQ
Measured: 6 months post-surgery
Pain coping strategies at 12 months post-surgery as assessed by CSQ
Measured: 12 months post-surgery
Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)
Measured: 24h before surgery
Hope at 1 month post-surgery as assessed by ESE
Measured: 1 month post-surgery
Hope at 6 months post-surgery as assessed by ESE
Measured: 6 months post-surgery
Hope at 12 months post-surgery as assessed by ESE
Measured: 12 months post-surgery
Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)
Measured: 24h before surgery
Self-Efficacy at 1 month post-surgery as assessed by KSESS
Measured: 1 month post-surgery
Self-Efficacy at 6 months post-surgery as assessed by KSESS
Measured: 6 months post-surgery
Self-Efficacy at 12 months post-surgery as assessed by KSESS
Measured: 12 months post-surgery
Salivary cortisol levels post-intervention
Measured: 24h before surgery
Salivary cortisol levels 72h post-surgery
Measured: 72h post-surgery
Salivary cortisol levels at 1 month post-surgery
Measured: 1 month post-surgery
Salivary cortisol levels at 6 months post-surgery
Measured: 6 months post-surgery
Salivary cortisol levels at 12 months post-surgery
Measured: 12 months post-surgery
Salivary α-amylase levels post-intervention
Measured: 24h before surgery
Salivary α-amylase levels 72h post-surgery
Measured: 72h post-surgery
Salivary α-amylase levels at 1 month post-surgery
Measured: 1 month post- surgery
Salivary α-amylase at 6 months post-surgery
Measured: 6 months post-surgery
Salivary α-amylase at 12 months post-surgery
Measured: 12 months post-surgery
Inflammatory biomarkers
IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP
Measured: 24h before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start1 Jan 2018
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Why it stopped: Unavailability of the clinical team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Braga
- Responsible party
- Principal investigator, Patrícia Ribeiro Pinto, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988947
- Sponsor's protocol ID
- SFRH/BPD/103529/2014
- Acronym
- PsInTKA
- Status last verified
- Apr 2021
- First submitted
- 9 Aug 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psychological Intervention for the Control and Prevention of Pain and for Surgical Recovery in Patients Undergoing Total Knee Arthroplasty: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02988947
- Acronym / sponsor ID
- PsInTKA / SFRH/BPD/103529/2014
- Conditions
- Knee Arthroplasty, Total
- Keywords
- Knee Arthroplasty, Hypnosis, Pain Neuroscience Education, Pain, Catastrophizing, Optimism, Distress, Hope
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unavailability of the clinical team
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Hospital de Braga
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 12 Dec 2016 (estimated)
- 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.
The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty
Detailed description
This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG), submitted to usual treatment and care.
After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and, afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement sessions. At 1 month post-surgery, the intervention group will be subdivided and participants will be randomly assigned to receive a reinforcement session or no intervention at this point. The psychological intervention sessions are based on the educative principles of Pain Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive coping strategies and psychological variables.
Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6 months post surgery; T5 - 12 months post intervention. Patients will fill in self report measures and perform physiological evaluation to analyse relevant bio-markers (salivary cortisol and α-amylase) that are related to stress levels and SNS functioning and translate the impact of psychological interventions on physiological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (PNE+HyP) | Experimental | Other: PNE+HyPPatients in this group will have 3 pre-surgical + 1 (or 2) reinforcement sessions in adition to standard TKA care. These interventions are based on Pain Neuroscience Education and Hypnosis and delivered according to standardized scripts. |
| Control Group | No intervention | –No intervention / Standard care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned unilateral total knee arthroplasty due to gonarthrosis
- Giving consent to participate
Key exclusion criteria (9 listed)
- Inability to write and read
- Cognitive deficit (assessed by MMSE)
- Revision TKA
- Bilateral TKA
- TKA for reasons other than gonarthrosis (fracture, malignancy or infection)
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 |
|---|---|---|
| PNE+HyPThis is a combined PNE and Hypnosis psychological intervention. PNE is a cognitive based approach that highlights the biopsychosocial model of pain and focuses on neurophysiological and neurobiological processes and pain representation. Hypnosis aims at promoting pain control, increasing positive coping strategies, and targeting positive psychological variables. | Other | Intervention Group (PNE+HyP) |
Primary outcome
Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
Time frame: 24h before surgery
Pain intensity 72h post-surgery as assessed by NRS
Time frame: 72h post-surgery
Pain intensity 1 month post-surgery as assessed by NRS and WOMAC
Time frame: 1 month post-surgery
Pain intensity 6 months post-surgery as assessed by NRS and WOMAC
Time frame: 6 months post-surgery
Pain intensity 12 months post-surgery as assessed by NRS and WOMAC
Time frame: 12 months post-surgery
39 secondary outcomes
Physical functioning post-intervention as assessed by WOMAC
Time frame: 24h before surgery
Physical functioning 1 month post-surgery as assessed by WOMAC
Time frame: 1 month post-surgery
Physical functioning 6 months post-surgery as assessed by WOMAC
Time frame: 6 months post-surgery
Physical functioning 12 months post-surgery as assessed by WOMAC
Time frame: 12 months post-surgery
Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)
Time frame: 24h before surgery
Pain knowledge 1 month post-surgery as assessed by the NPQ
Time frame: 1 month post-surgery
Pain knowledge 6 months post-surgery as assessed by NPQ
Time frame: 6 months post-surgery
Pain knowledge 12 months post-surgery as assessed by NPQ
Time frame: 12 months post-surgery
Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 24h before surgery
Emotional distress 1 month post-surgery as assessed by HADS
Time frame: 1 month post-surgery
Emotional distress 6 months post-surgery as assessed by HADS
Time frame: 6 months post-surgery
Emotional distress 12 months post-surgery as assessed by HADS
Time frame: 12 months post-surgery
Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)
Time frame: 24h before surgery
Optimism 1 month post-surgery as assessed by LOT
Time frame: 1 month post-surgery
Optimism 6 months post-surgery as assessed by LOT-R
Time frame: 6 months post-surgery
Optimism 12 months post-surgery as assessed LOT-R
Time frame: 12 months post-surgery
Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)
Time frame: 24h before surgery
Pain coping strategies 1 month post-surgery as assessed by CSQ
Time frame: 1 month post-surgery
Pain coping strategies at 6 months post-surgery as assessed by CSQ
Time frame: 6 months post-surgery
Pain coping strategies at 12 months post-surgery as assessed by CSQ
Time frame: 12 months post-surgery
Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)
Time frame: 24h before surgery
Hope at 1 month post-surgery as assessed by ESE
Time frame: 1 month post-surgery
Hope at 6 months post-surgery as assessed by ESE
Time frame: 6 months post-surgery
Hope at 12 months post-surgery as assessed by ESE
Time frame: 12 months post-surgery
Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)
Time frame: 24h before surgery
Self-Efficacy at 1 month post-surgery as assessed by KSESS
Time frame: 1 month post-surgery
Self-Efficacy at 6 months post-surgery as assessed by KSESS
Time frame: 6 months post-surgery
Self-Efficacy at 12 months post-surgery as assessed by KSESS
Time frame: 12 months post-surgery
Salivary cortisol levels post-intervention
Time frame: 24h before surgery
Salivary cortisol levels 72h post-surgery
Time frame: 72h post-surgery
Salivary cortisol levels at 1 month post-surgery
Time frame: 1 month post-surgery
Salivary cortisol levels at 6 months post-surgery
Time frame: 6 months post-surgery
Salivary cortisol levels at 12 months post-surgery
Time frame: 12 months post-surgery
Salivary α-amylase levels post-intervention
Time frame: 24h before surgery
Salivary α-amylase levels 72h post-surgery
Time frame: 72h post-surgery
Salivary α-amylase levels at 1 month post-surgery
Time frame: 1 month post- surgery
Salivary α-amylase at 6 months post-surgery
Time frame: 6 months post-surgery
Salivary α-amylase at 12 months post-surgery
Time frame: 12 months post-surgery
Inflammatory biomarkers
Time frame: 24h before surgery
Results and safety
The study was stopped early (reason given: Unavailability of the clinical team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNE+HyP in people with Knee Arthroplasty, Total, run by University of Minho at 1 site in Portugal.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 30 Apr 2021. 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 Portugal. 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?
The study was stopped early (reason given: Unavailability of the clinical team). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC (time frame: 24h before surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2021.