Central Sensitization in Total Knee Arthroplasty Patients with Persistent Pain

NCT05575310 | Completed

• 1 other identifier: CS-TKA
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic Postsurgical; Knee Osteoarthritis; Sensitization, Central

Outcome Measures

Primary Outcomes (2)

• Conditioned Pain Modulation at 3 months

  Experimental tonic pain will be induced by immersing the hand against the side in cold water following the Cold Pressor Test protocol (CPT). CPT will be performed by holding the contralateral hand immersed in water at 12±1 °C up to the wrist for a period of 2 minutes. The evaluation of pain thresholds to pressure will be performed after 45 seconds of immersion at location 1 of the peripatellar region (bilateral) and to the dominant forearm. Both evaluation points have been described in the section on pressure pain thresholds. The final value corresponding to the conditioned modulation of pain will be obtained from the difference between the value obtained during the application of the conditioning stimulus and the previous value. The unit of measurement will be in kilopascals (kPa) (conditioned pain modulation = pain threshold at pressure during application of cold - pain threshold at pressure before application of cold).

  3 months after surgery

• Conditioned Pain Modulation at 6 months

  Experimental tonic pain will be induced by immersing the hand against the side in cold water following the Cold Pressor Test protocol (CPT). CPT will be performed by holding the contralateral hand immersed in water at 12±1 °C up to the wrist for a period of 2 minutes. The evaluation of pain thresholds to pressure will be performed after 45 seconds of immersion at location 1 of the peripatellar region (bilateral) and to the dominant forearm. Both evaluation points have been described in the section on pressure pain thresholds. The final value corresponding to the conditioned modulation of pain will be obtained from the difference between the value obtained during the application of the conditioning stimulus and the previous value. The unit of measurement will be in kilopascals (kPa) (conditioned pain modulation = pain threshold at pressure during application of cold - pain threshold at pressure before application of cold).

  6 months after surgery

Secondary Outcomes (3)

• Pressure Pain Threshold

  3 and 6 months after surgery

• Health Functioning

  3 and 6 months after surgery

• Pain intensity

  3 and 6 months after surgery

Study Arms (2)

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.

Procedure: 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

Procedure: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

Articular knee surface replacement

No Persistent Post Surgical Pain; Persistent Post Surgical Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who underwent total knee arthroplasty due to symptomatic, end-stage knee ostheoarthritis.

You may qualify if:

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

You may not qualify if:

• Patients operated due to a revision surgery.
• 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.
• 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.

Sponsors & Collaborators

• University of Barcelona: lead
• Consorci Hospitalari de Vic: collaborator
• University of Vic - Central University of Catalonia: collaborator

Study Sites (1)

Consorci Hospitalari de Vic

Vic, Barcelona, 08500, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marc Terradas-Monllor

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: October 12, 2022
• Study Start: January 1, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

ES (1)