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CompletedNo phase

Central Sensitization in Total Knee Arthroplasty Patients with Persistent Pain

Key facts

Who runs it
University of Barcelona
Where
Spain1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
117 people enrolled
Started
1 Jan 2023
Ended
22 Oct 2024
Type of study
Observational, 2 groups
Treatments tested
  • Total Knee Arthroplasty
Record updated
24 October 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Patients who underwent total knee arthroplasty due to painful primary osteoarthritis

Who cannot take part

  • Patients operated due to a revision surgery
  • Patients with inflammatory or rheumatic diseases such as: rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis
  • Patients with mental health conditions and/or major depression
  • Patients with a unicompartmental knee arthroplasty
  • Pateints operated due to a fracture
  • Patients planning to undergo another lower extremity operation during the following 12 months

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Persistent post-surgical pain is a significant adverse effect after total knee arthroplasty, present in around 20% of the patients. Central sensitization may contribute to developing and maintaining pain. Therefore studies should investigate if pain processing altered mechanisms are present in this population.

The 2 groups in the trial

  • No Persistent Post Surgical Pain

    The grouping variable will be the presence or not of persistent post-surgical pain. This will be a dichotomous variable obtained from the evaluation of pain intensity at 3 months after surgery. The tool used will be a 100mm Visual Analog Scale (VAS) (0 = no pain, 100 = worst pain imaginable) (25). Those with a VAS \< 30 will be considered as patients with no persistent pain, while those with a VAS ≥ 30 will be considered as patients with persistent pain. This cut-off point has been determined by numerous authors in previous studies.

    Treatment: Total Knee Arthroplasty

  • Persistent Post Surgical Pain

    While those with a VAS ≥ 30 will be considered as patients with persistent pain. This cut-off point has been determined by numerous authors in previous studies

    Treatment: Total Knee Arthroplasty

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Central Sesitization in Patients with Persistent Postsurgical Pain After a Knee Arthroplasty: a Prospective, Case Control, Observational Study
Publications
Record updated
24 October 2024