Smallest Clinically Meaningful Improvement in Amputation-Related Pain and Brief Pain Inventory Scores as Defined by Patient Reports of Global Improvement After Cryoneurolysis: a Retrospective Analysis of a Randomized, Controlled Clinical Trial

Ilfeld, BM; Smith, CR; Turan, A; Mariano, ER; Miller, ME; Fisher, RL; Trescot, AM; Cohen, SP; Eisenach, JC; Sessler, DI; Prologo, JD; Mascha, EJ; Liu, L; Gabriel, RA; PAINfRE Investigators

doi:10.1213/ane.0000000000006833

Pain medicine

Smallest Clinically Meaningful Improvement in Amputation-Related Pain and Brief Pain Inventory Scores as Defined by Patient Reports of Global Improvement After Cryoneurolysis: a Retrospective Analysis of a Randomized, Controlled Clinical Trial

Anesth AnalgPublished 15 Nov 2024Secondary analysis of a randomised controlled trial

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Authors' conclusion

Amputees with phantom limb pain treated with percutaneous cryoneurolysis rate analgesic improvements as clinically meaningful similar to pharmacologic treatments, although their MCID for the Brief Pain Inventory was somewhat larger than previously published values.

Study context

Population: Patients with a lower-limb amputation and established phantom pain
Participants: 144 patients

Comparison: Ultrasound-guided percutaneous cryoneurolysis vs sham treatment
Primary endpoint: Phantom limb pain (NRS) and Brief Pain Inventory interference subscale scores
Follow-up: 4 months

Methodological detailsretrospective analysis, multicentre, masked, sham-controlled, anchor-based method

Retrospective analysis
Multicentre
Masked
Sham-controlled
Anchor-based method

Primary result

As reported in the abstract

MCID by Patient Global Impression of Change (PGIC) anchor

Phantom pain numeric rating scale (NRS) (0-10) improvement, small change, median [IQR]: 1 [1-1]
Phantom pain NRS (0-10) improvement, medium change, median [IQR]: 3 [3-4]
Phantom pain NRS (0-10) improvement, large change, median [IQR]: 4 [3-6]
Brief Pain Inventory interference (0-70) improvement, small change, median [IQR]: 16 [6-18]
Brief Pain Inventory interference (0-70) improvement, medium change, median [IQR]: 24 [22-31]
Brief Pain Inventory interference (0-70) improvement, large change, median [IQR]: 34 [22-46]

Further findings

Outcome	Active	Sham	← Lower risk with active ←→ Higher risk with active →	RR (95% CI)	P value
PGIC ≥5	33%	36%	0.512	0.9 (0.6–1.4)	P = 0.667
			0.512Relative risk (log scale)

Original publication

Smallest Clinically Meaningful Improvement in Amputation-Related Pain and Brief Pain Inventory Scores as Defined by Patient Reports of Global Improvement After Cryoneurolysis: a Retrospective Analysis of a Randomized, Controlled Clinical Trial. Anesth Analg. Published 15 November 2024. doi:10.1213/ane.0000000000006833

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