NCT02988947

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

August 9, 2016

Last Update Submit

April 27, 2021

Conditions

Knee Arthroplasty, Total

Keywords

Knee ArthroplastyHypnosisPain Neuroscience EducationPainCatastrophizingOptimismDistressHopeSelf-Efficacy

Outcome Measures

Primary Outcomes (5)

  • Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC

    24h before surgery

  • Pain intensity 72h post-surgery as assessed by NRS

    72h post-surgery

  • Pain intensity 1 month post-surgery as assessed by NRS and WOMAC

    1 month post-surgery

  • Pain intensity 6 months post-surgery as assessed by NRS and WOMAC

    6 months post-surgery

  • Pain intensity 12 months post-surgery as assessed by NRS and WOMAC

    12 months post-surgery

Secondary Outcomes (39)

  • Physical functioning post-intervention as assessed by WOMAC

    24h before surgery

  • Physical functioning 1 month post-surgery as assessed by WOMAC

    1 month post-surgery

  • Physical functioning 6 months post-surgery as assessed by WOMAC

    6 months post-surgery

  • Physical functioning 12 months post-surgery as assessed by WOMAC

    12 months post-surgery

  • Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)

    24h before surgery

  • +34 more secondary outcomes

Study Arms (2)

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.

Other: PNE+HyP

Control Group

NO INTERVENTION

No intervention / Standard care

Interventions

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.

Intervention Group (PNE+HyP)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life and Health Sciences Research Institute

Braga, 4710-057, Portugal

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral fellow

Study Record Dates

First Submitted

August 9, 2016

First Posted

December 12, 2016

Study Start

January 1, 2018

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)