ArticlePloS one2025
Duloxetine and pregabalin: High-dose monotherapy or their combination?-Study protocol for a randomized trial in patients with postoperative pain after total knee arthroplasty based on the classification of central sensitization inventory scores.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundResidual pain after total knee arthroplasty (TKA) often causes patient dissatisfaction. Patients with preoperative central sensitization (CS) are especially susceptible to chronic pain after TKA. Although duloxetine and pregabalin are known to relieve pain in CS patients, there is limited evidence on the precise effectiveness and safety of increasing the dosage or combining these medications. To address this gap, we designed a randomized, triple-blind clinical trial to assess the efficacy and safety of increasing the maximum dosage or combining these drugs for patients who do not respond to standard doses.
methodsPatients scheduled to undergo primary unilateral TKA will be screened for CS using the central sensitization inventory (CSI). CS patients will then be randomly assigned to Groups 1-5, while non-CS patients will be assigned to Group 6. All groups will receive multimodal analgesia. Groups 1 and 6 will receive a placebo. During the initial 6-week period, Groups 2 and 3 will take 60 mg/day of duloxetine, while Groups 4 and 5 will take 300 mg/day of pregabalin. Subsequently, non-responders will enter a 6-week period of high-dose/combination therapy. Group 2 will receive 120 mg/day of duloxetine, Group 3 and 4 will receive a combination of 60 mg/day of duloxetine and 300 mg/day of pregabalin, and Group 5 will receive 600 mg/day of pregabalin. The primary outcome will be to compare residual pain intensity at 6 months between the high-dose monotherapy groups (Groups 2, 5 pooled) and the combination therapy groups (Groups 3, 4 pooled), which will be measured using the brief pain inventory (BPI) 24-hour average pain change. Secondary outcomes will assess pain and functionality. DISCUSSION: This study aims to evaluate the efficacy and safety of increasing medication to the highest dose or combining two medications in patients with CS who have not responded well to standard doses of duloxetine or pregabalin after TKA. The goal is to provide clinicians with evidence-based recommendations for choosing an appropriate pain management strategy for these patients.
trial registrationChinese Clinical Trial Registry, ChiCTR2400081990. Registered on 18 March 2024.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.