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

Eva Lendaro, Eric J Earley, Max Ortiz-Catalan, Eva Lendaro, Eric J Earley, Max Ortiz-Catalan

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.gov NCT03112928 . 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.

Conflict of interest statement

The sponsor of this study (Integrum AB) is a for-profit organization that might commercialize the device used in this study (phantom motor execution and phantom motor imagery). MOC has provided consultancy for Integrum AB. EL and EJE have no conflict of interest to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flowchart. Abbreviations: PME phantom motor execution, PMI phantom motor imagery
Fig. 2
Fig. 2
Example of subjects’ profile of Pain Rating Index (PRI) over time by treatment group. The data used for this plot are fictitious

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Source: PubMed

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