Abstract

Background

Phantom limb pain (PLP) is a detrimental condition that can greatly diminish the quality of life. Purposeful control over the phantom limb activates the affected neural circuitry and leads to dissolution of the pathological relationship linking sensorimotor and pain processing (which gives rise to PLP). An international, double-blind, randomized controlled clinical trial (RCT) on the use of phantom motor execution (PME) as a treatment for PLP is currently undertaken, where PME is compared to an active placebo treatment, namely phantom motor imagery (PMI).

Methods and design

Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned in 2:1 ratio to PME or PMI interventions respectively. Subjects allocated to either treatment receive 15 interventions where they are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are performed (PME) or imagined (PMI).

Results

The primary outcome of the study is to examine whether 15 sessions of PME can induce a greater PLP relief, compared to PMI. The secondary objectives are to examine whether 15 sessions of PME provide a greater improvement in different aspects related to PLP compared to PMI, such as pain duration, pain intensity as measured by other metrics, and the patient’s own impression about the effect of treatment. Long-term retention of treatment benefits will be assessed as change in all the variables (both primary and secondary) between baseline and follow-up timepoints (at 1, 3, and 6 months post-treatment).

Conclusion

This manuscript serves as the formal statistical analysis plan (version 1.0) for the international, double-blind, randomized controlled clinical trial on the use of PME as a treatment for PLP. The statistical analysis plan was completed on 3 August 2021.

Trial registration

ClinicalTrials.govNCT03112928. Registered on April 13, 2017

SAP version: version: 1.0, date: 2021/08/03

Protocol version: This document has been written based on information contained in the study protocol published in Lendaro et al. (BMJ Open 8:e021039, 2018), in July 2018.

SAP revisions: Not applicable

Details

Title
Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain
Author
Lendaro, Eva 1   VIAFID ORCID Logo  ; Earley, Eric J. 2 ; Ortiz-Catalan, Max 3 

1  Center for Bionics and Pain Research, Mölndal, Sweden; Chalmers University of Technology, Department of Electrical Engineering, Gothenburg, Sweden (GRID:grid.5371.0) (ISNI:0000 0001 0775 6028) 
2  Center for Bionics and Pain Research, Mölndal, Sweden (GRID:grid.5371.0); Chalmers University of Technology, Department of Electrical Engineering, Gothenburg, Sweden (GRID:grid.5371.0) (ISNI:0000 0001 0775 6028) 
3  Center for Bionics and Pain Research, Mölndal, Sweden (GRID:grid.5371.0); Chalmers University of Technology, Department of Electrical Engineering, Gothenburg, Sweden (GRID:grid.5371.0) (ISNI:0000 0001 0775 6028); Sahlgrenska University Hospital, Operational Area 3, Gothenburg, Sweden (GRID:grid.1649.a) (ISNI:000000009445082X); University of Gothenburg, Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden (GRID:grid.8761.8) (ISNI:0000 0000 9919 9582) 
Pages
138
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-021-05962-7
ProQuest document ID
2730343122
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.