Characteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study

NCT07110324 | Recruiting

• 1 other identifier: 20042025PAINCOMPO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Despite high success rates of hip and knee arthroplasty, up to 20% of patients report moderate-to-severe pain (NRS \> 3) persisting beyond the expected healing period. This investigator-initiated, descriptive cohort study will re-invite approximately 100 consenting patients with persistent postoperative pain-identified from a pool of \~7 000 respondents-to complete standardized assessments of neuropathic (DN4), nociplastic (IASP criteria + Fibromyalgia Survey Questionnaire) and nociceptive (KOOS/HOOS pain domains) pain. Primary outcomes are the prevalence of potential nociplastic pain and the proportion experiencing significant pain in two or more mechanistic categories. Secondary analyses will compare baseline vs. re-evaluated DN4 scores, FSQ and KOOS/HOOS distributions, and examine differences between patients with and without possible neuropathic pain. Findings will inform targeted pre- and postoperative pain management strategies.

Conditions

Pain (Visceral, Somatic, or Neuropathic); Hip Arthroplasty Replacement; Knee Arthroplasty, Total; Survey and Questionnaire

Keywords

Pain; hip arthroplasty; knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Potential nociplastic pain

  Prevalence of potential nociplastic pain (defined by International Association for the Study of Pain criteria)

  1 year

Secondary Outcomes (4)

• Difference between baseline and re-evaluated neuropathic pain score.

  1 year

• Prevalence of potential nociplastic pain, as assessed with the Fibromyalgia Survey Questionnaire score.

  1 year

• Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)

  1 year

• Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)

  1 year

Other Outcomes (6)

• Difference in pain distribution in terms of International Association for the Study of Pain score in patients with possible neuropathic pain (neuropathic pain score above 3) and patients without any kind of neuropathic pain (score equal to zero).

  1 year

• Rates of satisfaction

  1 year

• Rates of consideration of re-operation.

  1 year

Study Arms (1)

Persistant pain (NRS above 3)

Explore the pain composition in terms of neuropathic, nociceptive and nociplastic pain in patients with persistent pain after total knee arthroplasty (TKA), total hip arthroplasty (THA), or unicompartmental knee arthroplasty (UKA).

Eligibility Criteria

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

Study Population

Descriptive Cohort Study: Approximately 7,000 patients have been administered questionnaires to indicate persistent postoperative pain including the DN4 questionnaire to indicate potential neuropathic pain \[6\]. All patients with evidence of persistent pain following operation and have consented to be contacted, will receive invitation to participate in the study to complete new patient-reported outcome measures (PROMs). For comparison in pain composition between patients with and without possible neuropathic pain, we expect to include 100 patients with possible neuropathic pain, as around 6% of the 7,000 (with 25% consenting to be contacted) scored high enough to consider possible neuropathic pain.

You may qualify if:

• All patients with persistent moderate-severe pain (NRS\>3) after THA, TKA and UKA
• Acceptance to be contacted.

You may not qualify if:

• Re-operation
• Luxation
• Do not want to be contacted
• Post-operative complications such as prosthesis infection, thromboembolism or fracture of the prosthesis.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Rigshospitalet

Østerbro, København Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Milan Mohammad, MD

CONTACT

+4560162372; milanmohammad@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 7, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

DK (1)