Objective: The Neuropathic Pain Symptom Inventory (NPSI) is commonly used assessment in Neuropathic Pain (NP) trials, yet a Minimal Clinically Important Difference (MCID) has not been established. A MCID would enhance the interpretability of NPSI scores, guiding clinicians and researchers in assessing clinically important improvements in NP symptoms. The aim of this study was to calculate an MCID from the available scientific research that used the NPSI. Methods: We conducted a systematic review and meta-analysis of NP trials reporting the NPSI. Three distributional approaches were applied to estimate the MCID: pooled standard deviation (SD) of change scores, pooled baseline SD, and a random-effects meta-analytic approach. Only treatments arms within RTCs were examined. Treatment arms were grouped by NP etiology, enabling etiology-specific MCID estimates. Bias for each included study was assessed using the Cochrane tool for quality assessment of randomized controlled trials. Results: 323 trials were examined, 12 were selected for inclusion for a total of 17 treatment arms. The calculated MCID estimates for the NPSI total score were 7.95 using pooled SD of change scores, 7.73 using pooled baseline SD, and 6.85 using the random-effects method. Etiology-specific MCIDs varied, with Post-Infectious conditions and Diabetic Peripheral Neuropathy showing higher values than other NP types. Conclusion: This study provides preliminary MCID estimates for the NPSI. Limitations include limited data for certain NP subtypes, highlighting the need for additional anchor-based and etiology-specific MCID research to refine these estimates. These findings can aid in future NP trial design and the interpretation of results.
Competing Interest StatementThe authors have declared no competing interest.
Funding StatementThe author(s) received no specific funding for this work.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This was a systematic review. no IRB was necessary.
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Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll relevant data are within the manuscript and/or its Supporting Information files.
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