Feasibility study to evaluate cycloidal vibration therapy for the symptomatic treatment of intermittent claudication

Research output: Contribution to journalArticle

Abstract

Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that Cycloidal Vibration Therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive Randomised Control Trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow up; safety, tolerability, compliance with therapy device. Additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication.
Methods
Patients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 minutes twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12.
Results
Thirty-four participants with IC were recruited: 30 (88%) male; 4 (12%) female. The rate of recruitment was 2.4 participants per month from a standard size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60-75 years). Substantive improvements were seen in comparison of differences in times to PFWT and MWT; in ABPI and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There was no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12 weeks course indicated a high degree of patient acceptability.

Conclusion
The statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise (Stewart et al., 2002). The substantive improvement in systolic leg pressure in the treated leg, and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect.

This study has provided novel information relating to number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies.
In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.
Original languageEnglish
JournalPilot and Feasibility Studies
Publication statusAccepted/In press - 14 Oct 2019

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Intermittent Claudication
Feasibility Studies
Vibration
Leg
Walking
Therapeutics
Blood Pressure
Safety
Ankle Brachial Index

Cite this

@article{1fea64424ea043709f2e8f7e28bab006,
title = "Feasibility study to evaluate cycloidal vibration therapy for the symptomatic treatment of intermittent claudication",
abstract = "Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that Cycloidal Vibration Therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive Randomised Control Trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow up; safety, tolerability, compliance with therapy device. Additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication. MethodsPatients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 minutes twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12. ResultsThirty-four participants with IC were recruited: 30 (88{\%}) male; 4 (12{\%}) female. The rate of recruitment was 2.4 participants per month from a standard size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60-75 years). Substantive improvements were seen in comparison of differences in times to PFWT and MWT; in ABPI and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There was no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12 weeks course indicated a high degree of patient acceptability.ConclusionThe statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise (Stewart et al., 2002). The substantive improvement in systolic leg pressure in the treated leg, and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect.This study has provided novel information relating to number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies. In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.",
keywords = "Peripheral arterial disease, Intermittent Claudication, Vascular Disease, Cycloidal Vibration therapy, Vibropulse",
author = "Leanne Atkin and John Stephenson and Karen Ousey",
year = "2019",
month = "10",
day = "14",
language = "English",
journal = "Pilot and Feasibility Studies",
issn = "2055-5784",
publisher = "BioMed Central Ltd.",

}

TY - JOUR

T1 - Feasibility study to evaluate cycloidal vibration therapy for the symptomatic treatment of intermittent claudication

AU - Atkin, Leanne

AU - Stephenson, John

AU - Ousey, Karen

PY - 2019/10/14

Y1 - 2019/10/14

N2 - Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that Cycloidal Vibration Therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive Randomised Control Trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow up; safety, tolerability, compliance with therapy device. Additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication. MethodsPatients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 minutes twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12. ResultsThirty-four participants with IC were recruited: 30 (88%) male; 4 (12%) female. The rate of recruitment was 2.4 participants per month from a standard size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60-75 years). Substantive improvements were seen in comparison of differences in times to PFWT and MWT; in ABPI and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There was no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12 weeks course indicated a high degree of patient acceptability.ConclusionThe statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise (Stewart et al., 2002). The substantive improvement in systolic leg pressure in the treated leg, and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect.This study has provided novel information relating to number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies. In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.

AB - Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that Cycloidal Vibration Therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive Randomised Control Trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow up; safety, tolerability, compliance with therapy device. Additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication. MethodsPatients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 minutes twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12. ResultsThirty-four participants with IC were recruited: 30 (88%) male; 4 (12%) female. The rate of recruitment was 2.4 participants per month from a standard size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60-75 years). Substantive improvements were seen in comparison of differences in times to PFWT and MWT; in ABPI and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There was no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12 weeks course indicated a high degree of patient acceptability.ConclusionThe statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise (Stewart et al., 2002). The substantive improvement in systolic leg pressure in the treated leg, and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect.This study has provided novel information relating to number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies. In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.

KW - Peripheral arterial disease

KW - Intermittent Claudication

KW - Vascular Disease

KW - Cycloidal Vibration therapy

KW - Vibropulse

M3 - Article

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

ER -