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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Persistant pain (NRS above 3)

Trial outcomes

Primary outcomes

1

Potential nociplastic pain

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

Time frame
1 year

Secondary outcomes

1

Difference between baseline and re-evaluated neuropathic pain score.

Difference between baseline and re-evaluated neuropathic pain score.

Time frame
1 year
2

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.

Time frame
1 year
3

Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)

Distribution of Knee injury and Osteoarthritis Outcome Score (KOOS)

Time frame
1 year
4

Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)

Distribution of Hip injury and Osteoarthritis Outcome Score (HOOS)

Time frame
1 year

Other outcomes

1

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).

Time frame
1 year
2

Rates of satisfaction

Rates of satisfaction

Time frame
1 year
3

Rates of consideration of re-operation.

Rates of consideration of re-operation.

Time frame
1 year
4

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).

Time frame
1 year

Sponsors and contacts

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Rigshospitalet, Denmark

Lead sponsor

Bispebjerg Hospital

Collaborator