About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with persistent moderate-severe pain (NRS>3) after THA, TKA and UKA
Acceptance to be contacted.
Disqualifiers
Re-operation
Luxation
Do not want to be contacted
Post-operative complications such as prosthesis infection, thromboembolism or fracture of the prosthesis.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Potential nociplastic pain
Prevalence of potential nociplastic pain (defined by International Association for the Study of Pain criteria)
Secondary outcomes
Difference between baseline and re-evaluated neuropathic pain score.
Difference between baseline and re-evaluated neuropathic pain score.
Prevalence of potential nociplastic pain, as assessed with the Fibromyalgia Survey Questionnaire score.
Prevalence of potential nociplastic pain, as assessed with the Fibromyalgia Survey Questionnaire score.
Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)
Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)
Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)
Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)
Other outcomes
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).
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).
Rates of satisfaction
Rates of satisfaction
Rates of consideration of re-operation.
Rates of consideration of re-operation.
Difference in pain distribution in terms of Fibromyalgia Survey Questionnaire score in patients with possible neuropathic pain (neuropathic pain score above 3) and patients without any kind of neuropathic pain (score equal to zero).
Difference in pain distribution in terms of Fibromyalgia Survey Questionnaire score in patients with possible neuropathic pain (neuropathic pain score above 3) and patients without any kind of neuropathic pain (score equal to zero).
Sponsors and contacts
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Rigshospitalet, Denmark
Lead sponsor
Bispebjerg Hospital
Collaborator