Clinical trial NCT02988947: Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Arthroplasty, Total
Keywords: Knee Arthroplasty
Hypnosis
Pain Neuroscience Education
Pain
Catastrophizing
Optimism
Distress
Hope
Self-Efficacy
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital de Braga
First posted: 2016-12-12
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Planned unilateral total knee arthroplasty due to gonarthrosis
* Giving consent to participate

Exclusion Criteria:

* 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')
* 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

Primary outcomes:
measure: Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
timeFrame: 24h before surgery
measure: Pain intensity 72h post-surgery as assessed by NRS
timeFrame: 72h post-surgery
measure: Pain intensity 1 month post-surgery as assessed by NRS and WOMAC
timeFrame: 1 month post-surgery
measure: Pain intensity 6 months post-surgery as assessed by NRS and WOMAC
timeFrame: 6 months post-surgery
measure: Pain intensity 12 months post-surgery as assessed by NRS and WOMAC
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Physical functioning post-intervention as assessed by WOMAC
timeFrame: 24h before surgery
measure: Physical functioning 1 month post-surgery as assessed by WOMAC
timeFrame: 1 month post-surgery
measure: Physical functioning 6 months post-surgery as assessed by WOMAC
timeFrame: 6 months post-surgery
measure: Physical functioning 12 months post-surgery as assessed by WOMAC
timeFrame: 12 months post-surgery
measure: Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)
timeFrame: 24h before surgery
measure: Pain knowledge 1 month post-surgery as assessed by the NPQ
timeFrame: 1 month post-surgery
measure: Pain knowledge 6 months post-surgery as assessed by NPQ
timeFrame: 6 months post-surgery
measure: Pain knowledge 12 months post-surgery as assessed by NPQ
timeFrame: 12 months post-surgery
measure: Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24h before surgery
measure: Emotional distress 1 month post-surgery as assessed by HADS
timeFrame: 1 month post-surgery
measure: Emotional distress 6 months post-surgery as assessed by HADS
timeFrame: 6 months post-surgery
measure: Emotional distress 12 months post-surgery as assessed by HADS
timeFrame: 12 months post-surgery
measure: Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)
timeFrame: 24h before surgery
measure: Optimism 1 month post-surgery as assessed by LOT
timeFrame: 1 month post-surgery
measure: Optimism 6 months post-surgery as assessed by LOT-R
timeFrame: 6 months post-surgery
measure: Optimism 12 months post-surgery as assessed LOT-R
timeFrame: 12 months post-surgery
measure: Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)
timeFrame: 24h before surgery
measure: Pain coping strategies 1 month post-surgery as assessed by CSQ
timeFrame: 1 month post-surgery
measure: Pain coping strategies at 6 months post-surgery as assessed by CSQ
timeFrame: 6 months post-surgery
measure: Pain coping strategies at 12 months post-surgery as assessed by CSQ
timeFrame: 12 months post-surgery
measure: Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)
timeFrame: 24h before surgery
measure: Hope at 1 month post-surgery as assessed by ESE
timeFrame: 1 month post-surgery
measure: Hope at 6 months post-surgery as assessed by ESE
timeFrame: 6 months post-surgery
measure: Hope at 12 months post-surgery as assessed by ESE
timeFrame: 12 months post-surgery
measure: Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)
timeFrame: 24h before surgery
measure: Self-Efficacy at 1 month post-surgery as assessed by KSESS
timeFrame: 1 month post-surgery
measure: Self-Efficacy at 6 months post-surgery as assessed by KSESS
timeFrame: 6 months post-surgery
measure: Self-Efficacy at 12 months post-surgery as assessed by KSESS
timeFrame: 12 months post-surgery
measure: Salivary cortisol levels post-intervention
timeFrame: 24h before surgery
measure: Salivary cortisol levels 72h post-surgery
timeFrame: 72h post-surgery
measure: Salivary cortisol levels at 1 month post-surgery
timeFrame: 1 month post-surgery
measure: Salivary cortisol levels at 6 months post-surgery
timeFrame: 6 months post-surgery
measure: Salivary cortisol levels at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Salivary α-amylase levels post-intervention
timeFrame: 24h before surgery
measure: Salivary α-amylase levels 72h post-surgery
timeFrame: 72h post-surgery
measure: Salivary α-amylase levels at 1 month post-surgery
timeFrame: 1 month post- surgery
measure: Salivary α-amylase at 6 months post-surgery
timeFrame: 6 months post-surgery
measure: Salivary α-amylase at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Inflammatory biomarkers
timeFrame: 24h before surgery
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Life and Health Sciences Research Institute
Study officials:
References: