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

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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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.

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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Factors related to phantom limb pain and its effect on quality of life

Somatosensory & Motor Research ◽

10.1080/08990220.2021.1973405 ◽

2021 ◽

pp. 1-5

Author(s):

Cemile S. Polat ◽

Hatice E. Konak ◽

Elif U. Altas ◽

Meltem G. Akıncı ◽

Sule S. Onat

Keyword(s):

Quality Of Life ◽

Phantom Limb Pain ◽

Phantom Limb ◽

Limb Pain

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Perceptions of phantom limb pain in lower limb amputees and its effect on quality of life: a qualitative study

British Journal of Pain ◽

10.1177/2049463715590884 ◽

2015 ◽

Vol 10 (2) ◽

pp. 70-77 ◽

Cited By ~ 9

Author(s):

Esmé G Trevelyan ◽

Warren A Turner ◽

Nicola Robinson

Keyword(s):

Quality Of Life ◽

Qualitative Study ◽

Lower Limb ◽

Phantom Limb Pain ◽

Phantom Limb ◽

Limb Pain ◽

Lower Limb Amputees

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Impact of oral rehabilitation on the quality of life of partially dentate elders in a randomised controlled clinical trial: 2 year follow-up

PLoS ONE ◽

10.1371/journal.pone.0203349 ◽

2018 ◽

Vol 13 (10) ◽

pp. e0203349 ◽

Cited By ~ 5

Author(s):

Gerald McKenna ◽

Patrick Finbarr Allen ◽

Martina Hayes ◽

Cristiane DaMata ◽

Ciaran Moore ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Oral Rehabilitation ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled ◽

Partially Dentate

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The impact of rehabilitation using removable partial dentures and functionally orientated treatment on oral health-related quality of life: A randomised controlled clinical trial

Journal of Dentistry ◽

10.1016/j.jdent.2014.06.006 ◽

2015 ◽

Vol 43 (1) ◽

pp. 66-71 ◽

Cited By ~ 27

Author(s):

Gerald McKenna ◽

P. Finbarr Allen ◽

Denis O’Mahony ◽

Michael Cronin ◽

Cristiane DaMata ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Health Related Quality ◽

Randomised Controlled Clinical Trial ◽

Related Quality ◽

Health Related ◽

Randomised Controlled ◽

The Impact

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Effect of counselling on health-promoting lifestyle and the quality of life in Iranian middle-aged women: a randomised controlled clinical trial

BMC Health Services Research ◽

10.1186/s12913-019-4176-0 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 2

Author(s):

Vahideh Karimlou ◽

Sakineh Mohammad-Alizadeh Charandabi ◽

Jamileh Malakouti ◽

Mojgan Mirghafourvand

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Middle Aged ◽

Randomised Controlled Clinical Trial ◽

Health Promoting ◽

Health Promoting Lifestyle ◽

Randomised Controlled

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Effects of high-load and low-load resistance training in patients with coronary artery disease: rationale and design of a randomised controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2021-051325 ◽

2021 ◽

Vol 11 (7) ◽

pp. e051325

Author(s):

Tim Kambic ◽

Nejc Šarabon ◽

Vedran Hadžić ◽

Mitja Lainscak

Keyword(s):

Quality Of Life ◽

Coronary Artery Disease ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Clinical Community ◽

Randomised Controlled Clinical Trial ◽

Registration Number ◽

Artery Disease ◽

Randomised Controlled

IntroductionResistance training (RT) combined with aerobic training (AT) enhances the effects of cardiac rehabilitation (CR) in patients with coronary artery disease (CAD). However, it remains to be investigated which type of RT (high loads (HLs) vs low loads (LLs)) is more efficacious in improving exercise performance, cardio-metabolic health and quality of life.Methods and analysisA randomised, controlled, clinical trial will enrol 20 patients with CAD into each of three study arms (total 60 patients): HL-RT (70%–80% of one repetition maximum (1-RM)) combined with AT; LL-RT (30%–40% of 1-RM) combined with AT and AT alone as standard care. Primary outcomes (maximal aerobic capacity, maximal leg isometric strength) will be assessed at baseline and after 36 training sessions. Other outcomes will include acute haemodynamic responses to LL-RT and HL-RT, body composition, physical performance, blood biomarkers (lipids, glucose metabolism, inflammation, growth factors), physical activity and quality of life. The intention-to-treat principle will be used to analyse the data.Ethics and disseminationThe study design and protocol have been approved by the National Medical Ethics Committee of Slovenia (registration number: 0120-573/2019/15). The study will be conducted in accordance with the Declaration of Helsinki. The results of the study will be published as peer-reviewed manuscripts and congress presentations, communicated with patients and the clinical community, and shared through posts on social media. The findings of the study will be disseminated among the national CR clinical community (CR centres, Slovenian association of coronary clubs) with active participation of the patients enrolled in the study. This study will expand our knowledge of RT in combination with AT in CR. We expect to find different effects of HL-RT versus LL-RT, with implications for RT strategies in rehabilitation of patients with CAD.Trial registration numberNCT04638764.

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