{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T13:06:36Z","timestamp":1765890396162,"version":"3.48.0"},"reference-count":44,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T00:00:00Z","timestamp":1753228800000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Chief Scientist Office","award":["TCS\/16\/55"],"award-info":[{"award-number":["TCS\/16\/55"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,6,27]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"\n Objectives<\/jats:title>\n To explore the feasibility and acceptability of pain management (transcutaneous electrical nerve stimulation (TENS)) and patient education (PE) to increase physical activity in people with peripheral arterial disease and intermittent claudication (IC).<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Feasibility randomised controlled trial with embedded process evaluation.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n One secondary care UK vascular centre.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n 56 community-dwelling adults with a history of stable IC and ankle-brachial pressure index \u22640.9 were recruited via claudication clinics.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants randomised to 6 weeks of: TENS+PE, TENS, Placebo TENS+PE or Placebo TENS. PE was a 3-hour workshop plus three follow-up phone calls. The TENS machine was worn during walking (TENS: 120 Hz, 200 \u03bcs, intensity \u2018strong but comfortable\u2019; Placebo TENS: intensity below sensation threshold).<\/jats:p>\n <\/jats:sec>\n \n Outcomes<\/jats:title>\n Primary feasibility outcomes included rates of recruitment, retention and adherence. Acceptability of the intervention and trial procedures was explored with semistructured interviews. Measures of walking capacity, walking behaviour, quality of life, disease perception and pain were recorded at baseline, end of intervention (6 weeks) and follow-up (3 months).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 56 participants were randomised from 95 who completed baseline screening. Of the 39 excluded, 97% (38\/39) had >20% variability in absolute claudication distance. All participants received their allocated intervention. Outcome completion was 91% at 6 weeks and 80% at 3 months. Attendance at group education was 96% with 63% taking follow-up phone calls. Compliance with TENS was 70% according to participant-completed logs. Interviewed participants (n=9) were generally positive about the acceptability of the interventions and trial procedures; however, experience of TENS use was mixed. Some participants were dissatisfied with the size of the device and electrode wires.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The PrEPAID (Pain management and Patient Education for Physical Activity in Intermittent claudication) trial was feasible to run; however, 40% of potential participants were excluded at screening due to issues of research fidelity rather than participant suitability or willingness to participate. A future definitive trial should consider a revised primary outcome measure and smaller wireless TENS machines.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ClinicalTrials.gov,\n NCT03204825<\/jats:ext-link>\n . Registered on 2 July 2017.\n <\/jats:p>\n <\/jats:sec>\n \n Trial funding<\/jats:title>\n Chief Scientist Office, Scottish Government. Translational grant award (TCS\/16\/55).<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-105563","type":"journal-article","created":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T04:10:58Z","timestamp":1753243858000},"page":"e105563","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Pain management and patient education interventions to increase physical activity in people with intermittent claudication (PrEPAID): a feasibility randomised controlled trial in the UK"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct03204825","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4379-7913","authenticated-orcid":false,"given":"Chris","family":"Seenan","sequence":"first","affiliation":[{"name":"Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ukachukwu","family":"Abaraogu","sequence":"additional","affiliation":[{"name":"Institute for Applied Social and Health Research, University of the West of Scotland, Paisley, Scotland, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippa Margaret","family":"Dall","sequence":"additional","affiliation":[{"name":"School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, Glasgow, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lesley","family":"Gilmour","sequence":"additional","affiliation":[{"name":"NHS Greater Glasgow and Clyde, Glasgow, Scotland, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8610-0613","authenticated-orcid":false,"given":"Garry","family":"Tew","sequence":"additional","affiliation":[{"name":"Institute for Health and Care Improvement, York St John University, York, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wesley","family":"Stuart","sequence":"additional","affiliation":[{"name":"NHS Greater Glasgow and Clyde, Glasgow, Scotland, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4172-4702","authenticated-orcid":false,"given":"Andrew","family":"Elders","sequence":"additional","affiliation":[{"name":"Glasgow Caledonian University, Glasgow, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Brittenden","sequence":"additional","affiliation":[{"name":"Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Glasgow, UK"},{"name":"Vascular Surgery, NHS Greater Glasgow and Clyde, Glasgow, Glasgow, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,7,22]]},"reference":[{"key":"2025121605003908000_15.7.e105563.1","doi-asserted-by":"crossref","first-page":"e1020","DOI":"10.1016\/S2214-109X(19)30255-4","article-title":"Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis","volume":"7","author":"Song","year":"2019","journal-title":"Lancet Glob Health"},{"key":"2025121605003908000_15.7.e105563.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199202063260605"},{"key":"2025121605003908000_15.7.e105563.3","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.114.303517"},{"key":"2025121605003908000_15.7.e105563.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2006.12.037"},{"key":"2025121605003908000_15.7.e105563.5","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1253\/circj.CJ-16-1286","article-title":"Pathophysiology of Intermittent Claudication in Peripheral Artery Disease","volume":"81","author":"Hamburg","year":"2017","journal-title":"Circ J"},{"key":"2025121605003908000_15.7.e105563.6","doi-asserted-by":"publisher","DOI":"10.1249\/00005768-199104000-00003"},{"key":"2025121605003908000_15.7.e105563.7","doi-asserted-by":"publisher","DOI":"10.1001\/jama.286.13.1599"},{"key":"2025121605003908000_15.7.e105563.8","doi-asserted-by":"publisher","DOI":"10.1001\/jama.292.4.453"},{"key":"2025121605003908000_15.7.e105563.9","first-page":"826","article-title":"The health-related quality of life of people with peripheral arterial disease in the community: the Edinburgh Artery Study","volume":"54","author":"Dumville","year":"2004","journal-title":"Br J Gen Pr: J R Coll Gen Pr"},{"key":"2025121605003908000_15.7.e105563.10","doi-asserted-by":"crossref","first-page":"573","DOI":"10.5551\/jat.62778","article-title":"Evidence-Based Recommendations for Medical Management of Peripheral Artery Disease","volume":"28","author":"Golledge","year":"2021","journal-title":"J Atheroscler Thromb"},{"key":"2025121605003908000_15.7.e105563.11","unstructured":"NICE . 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