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.

Mapping Intimacies ◽

10.21203/rs.3.rs-798862/v1 ◽

2021 ◽

Author(s):

Eva Lendaro

Keyword(s):

Clinical Trial ◽

Phantom Limb Pain ◽

Statistical Analysis Plan ◽

Phantom Limb ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Motor Execution ◽

Limb Pain ◽

Double Blind ◽

Randomized Controlled

Abstract Background Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Purposeful control over the phantom limb activates of 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 active placebo. Methods and design Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned in 2:1 ratio to PME or phantom motor imagery (PMI) interventions respectively. Subjects allocated to either treatment receive 15 interventions and 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 just 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 on 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 one-, three- and six-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 phantom motor execution as a treatment for phantom limb pain. The statistical analysis plan was completed on 3 August 2021. Trial registration number NCT03112928. 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 [1], in July 2018. SAP Revisions Not applicable

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Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2017-021039 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021039 ◽

Cited By ~ 4

Author(s):

Eva Lendaro ◽

Liselotte Hermansson ◽

Helena Burger ◽

Corry K Van der Sluis ◽

Brian E McGuire ◽

...

Keyword(s):

Quality Of Life ◽

Phantom Limb Pain ◽

Phantom Limb ◽

Controlled Clinical Trial ◽

Motor Execution ◽

Limb Pain ◽

Double Blind ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

IntroductionPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.Methods and analysisSixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment.Ethics and disseminationThe study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.Trial registration numberNCT03112928; Pre-results.

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