Efficacy and Feasibility of Pain management and Patient Education for Physical Activity in Intermittent claudication (PrEPAID): protocol for a randomised controlled trial

Ukachukwu O Abaraogu, Philippa M Dall, Julie Brittenden, Wesley Stuart, Garry A Tew, Jon Godwin, Christopher A Seenan, Ukachukwu O Abaraogu, Philippa M Dall, Julie Brittenden, Wesley Stuart, Garry A Tew, Jon Godwin, Christopher A Seenan

Abstract

Background: Physical activity (PA) improves functional capacity and quality of life and provides secondary prevention benefits in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC). However, pain and patient lack of knowledge are key barriers to the uptake of, and adherence to, PA recommendations. This trial will test the efficacy and feasibility of a non-invasive pain management intervention with and without patient education to improve PA in individuals with PAD and IC.

Methods: This is a randomised, controlled assessor-blinded feasibility trial with four parallel groups. Eighty adults with PAD and IC will be randomly assigned 1:1:1:1 to Active TENS (transcutaneous electrical nerve stimulation), Placebo TENS, Active TENS + Patient education or Placebo TENS + Patient education groups. All groups will continue to receive usual care over the intervention period. Participants randomised to Active TENS will receive a TENS device (preset at 120 Hz, 200 μs) and will be instructed to use the device daily at home or elsewhere for 6 weeks with a patient-determined intensity of "strong but comfortable". Placebo TENS group participants will receive the same model of TENS device and instructions for use as those in the active group, except that the stimulation dose will be safely altered to produce non-therapeutic, ineffective stimulation. Participants randomised to patient education will receive a one-off 3-h workshop of structured group education (four to five persons in each group) and three sets of twice-weekly phone calls. Efficacy outcomes will be assessed at baseline, after 6 weeks of intervention and at 3 months follow-up. Absolute claudication distance using the Gardner treadmill protocol will be assessed as the primary outcome. Secondary outcomes will assess initial claudication distance, daily PA and patient-reported outcomes including quality of life, pain self-efficacy, depression, disease perception and walking impairment pain intensity and quality. Feasibility outcomes will assess rates of recruitment, retention and adherence. Focus groups with participants at the end of the trial will explore the acceptability of the interventions.

Discussion: This trial will determine the efficacy and feasibility of using a low-cost, CE-marked non-invasive pain management modality delivered with or without a patient-centred education intervention to improve PA in individuals with PAD and IC.

Trial registration: ClinicalTrials.gov, NCT03204825 . Registered on 2 July 2017.

Keywords: Behavioural change therapy; Exercise; Intermittent claudication; Patient-centred care; Peripheral arterial disease; Physical activity; Transcutaneous electrical nerve stimulation.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the West of Scotland Research Ethic Committee 4 (17/WS/0094) and the NHS Greater Glasgow and Clyde Clinical Research and Development (GN16CE378). Written informed consent shall be obtained from each trial participant. The Research Nurse or another member of the study team will explain the exact nature of the study in writing and verbally, will provide the participant information sheets and will be responsible for consenting the participants. Trial participants will be informed that they are free to withdraw their consent from the study or study treatment at any time.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart for participant identification, inclusion, study design, interventions, assessments and follow-up
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure (numbers beside t represent weeks)

References

    1. Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA. 2006;295:547–553. doi: 10.1001/jama.295.5.547.
    1. Olin JW, Sealove BA. Peripheral artery disease: current insight into the disease and its diagnosis and management. Mayo Clin Proc. 2010;85:678–692. doi: 10.4065/mcp.2010.0133.
    1. Serrano Hernando FJ, Martín Conejero A. Peripheral artery disease: pathophysiology, diagnosis and treatment. Rev Española Cardiol. 2007;60:969–982. doi: 10.1157/13109651.
    1. Muir RL. Peripheral arterial disease: pathophysiology, risk factors, diagnosis, treatment, and prevention. J Vasc Nurs. 2009;27:26–30. doi: 10.1016/j.jvn.2009.03.001.
    1. Hamburg NM, Creager MA. Pathophysiology of intermittent claudication in peripheral artery disease. Circ J. 2017;81:281–289. doi: 10.1253/circj.CJ-16-1286.
    1. McDermott MMG. Lower extremity manifestations of peripheral artery disease: the pathophysiologic and functional implications of leg ischemia. Circ Res. 2015;116:1540–1550. doi: 10.1161/CIRCRESAHA.114.303517.
    1. Regensteiner JG, Hiatt WR, Coll JR, Criqui MH, Treat-Jacobson D, McDermott MM, et al. The impact of peripheral arterial disease on health-related quality of life in the Peripheral Arterial Disease Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) Program. Vasc Med. 2008;13:15–24. doi: 10.1177/1358863X07084911.
    1. Breek JC, De Vries J, Van Heck GL, Van Berge Henegouwen DP, Hamming JF. Assessment of disease impact in patients with intermittent claudication: discrepancy between health status and quality of life. J Vasc Surg. 2005;41:443–450. doi: 10.1016/j.jvs.2004.12.042.
    1. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2016;2017:e726–e779.
    1. Garg PK, Tian L, Criqui MH, Liu K, Ferrucci L, Guralnik JM, et al. Physical activity during daily life and mortality in patients with peripheral arterial disease. Circulation. 2006;114:242–248. doi: 10.1161/CIRCULATIONAHA.105.605246.
    1. Layden J, Michaels J, Bermingham S, Higgins B. Diagnosis and management of lower limb peripheral arterial disease: summary of NICE guidance. BMJ. 2012;345:e4947. doi: 10.1136/bmj.e4947.
    1. Fokkenrood H, Bendermacher B, Lauret G, Willigendael E, Prins M, Teijink J. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013;8:CD005263.
    1. Shalhoub J, Hamish M, Davies AH. Supervised exercise for intermittent claudication — an under-utilised tool. Ann R Coll Surg Engl. 2009;91:473–476. doi: 10.1308/003588409X432149.
    1. Gorely T, Crank H, Humphreys L, Nawaz S, Tew GA. “Standing still in the street”: experiences, knowledge and beliefs of patients with intermittent claudication—a qualitative study. J Vasc Nurs. 2015;33:4–9. doi: 10.1016/j.jvn.2014.12.001.
    1. Galea MN, Bray SR, Martin Ginis KA. Barriers and facilitators for walking in individuals with intermittent claudication. J Aging Phys Act. 2008;16:69–84. doi: 10.1123/japa.16.1.69.
    1. Abaraogu UO, Dall PM, Seenan CA. The effect of structured patient education on physical activity in patients with peripheral arterial disease and intermittent claudication: a systematic review. Eur J Vasc Endovasc Surg. 2017;54:58–68. doi: 10.1016/j.ejvs.2017.04.003.
    1. Tew GA, Humphreys L, Crank H, Hewitt C, Nawaz S, Al-Jundi W, et al. The development and pilot randomised controlled trial of a group education programme for promoting walking in people with intermittent claudication. Vasc Med. 2015;20:348–357. doi: 10.1177/1358863X15577857.
    1. Seenan C, Roche PA, Tan C-W, Mercer T. Modification of experimental, lower limb ischemic pain with transcutaneous electrical nerve stimulation. Clin J Pain. 2012;28:693–699. doi: 10.1097/AJP.0b013e318242fccb.
    1. Seenan C, McSwiggan S, Roche PA, Tan C-W, Mercer T, Belch JJF. Transcutaneous electrical nerve stimulation improves walking performance in patients with intermittent claudication. J Cardiovasc Nurs. 2016;31:323–330. doi: 10.1097/JCN.0000000000000258.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi: 10.1136/bmj.i5239.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Thompson PD, Arena R, Riebe D, Pescatello LS. American College of Sports Medicine. ACSM's New Preparticipation Health Screening Recommendations from ACSM's Guidelines for Exercise Testing and Prescription (9th Ninth Edition). Curr Sports Med Rep. 2013;12(4):215–7.
    1. Vance CGT, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014;4:197–209. doi: 10.2217/pmt.14.13.
    1. Ryan CG, King R, Robinson V, Punt TD, Dinse HR, Grunenberg C, et al. Transcutaneous electrical nerve stimulation using an LTP-like repetitive stimulation protocol for patients with upper limb complex regional pain syndrome: a feasibility study. Hand Therapy. 2016;0:1–12.
    1. Francis RP, Marchant P, Johnson MI. Conventional versus acupuncture-like transcutaneous electrical nerve stimulation on cold-induced pain in healthy human participants: effects during stimulation. Clin Physiol Funct Imaging. 2011;31:363–370. doi: 10.1111/j.1475-097X.2011.01025.x.
    1. Ryan CG, King R, Robinson V, Punt TD, Dinse HR, Grunenberg C, et al. Transcutaneous electrical nerve stimulation using an LTP-like repetitive stimulation protocol for patients with upper limb complex regional pain syndrome: a feasibility study. Hand Ther. 2017;22:52–63. doi: 10.1177/1758998316678588.
    1. Skinner TC, Carey ME, Cradock S, Daly H, Davies MJ, Doherty Y, et al. Diabetes education and self-management for ongoing and newly diagnosed (DESMOND): process modelling of pilot study. Patient Educ Couns. 2006;64:369–377. doi: 10.1016/j.pec.2006.04.007.
    1. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991;23:402–408. doi: 10.1249/00005768-199104000-00003.
    1. Clarke CL, Holdsworth RJ, Ryan CG, Granat MH. Free-living physical activity as a novel outcome measure in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2013;45:162–167. doi: 10.1016/j.ejvs.2012.11.027.
    1. Chong PFS, Garratt AM, Golledge J, Greenhalgh RM, Davies AH. The Intermittent Claudication Questionnaire: a patient-assessed condition-specific health outcome measure. J Vasc Surg. 2002;36:764–771. doi: 10.1016/S0741-5214(02)00131-3.
    1. Ware JE. SF-36® Health Survey Update [Internet]. SF Community. 2010. p. 1–16.
    1. Melzack R. The McGill Pain Questionnaire. Anesthesiology. 2005;103:199–202. doi: 10.1097/00000542-200507000-00028.
    1. Huskisson EC. Measurement of pain. Lancet. 1974;304:1127–1131. doi: 10.1016/S0140-6736(74)90884-8.
    1. Broadbent E, Petrie KJ, Main J, Weinman J. The Brief Illness Perception Questionnaire. J Psychosom Res. 2006;60:631–637. doi: 10.1016/j.jpsychores.2005.10.020.
    1. Greenberg SA. How to try this: the Geriatric Depression Scale: Short Form. Am J Nurs. 2007;107:60–69. doi: 10.1097/01.NAJ.0000292204.52313.f3.
    1. Nicholas MK. The Pain Self-Efficacy Questionnaire: taking pain into account. Eur J Pain. 2007;11:153–163. doi: 10.1016/j.ejpain.2005.12.008.
    1. Fergusson D. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325:652–654. doi: 10.1136/bmj.325.7365.652.
    1. McCoy E. Understanding the intention-to-treat principle in randomized controlled trials. West J Emerg Med. 2017;18:1075–1078. doi: 10.5811/westjem.2017.8.35985.
    1. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. doi: 10.1186/1471-2288-13-117.
    1. Parkinson S, Eatough V, Holmes J, Stapley E, Midgley N. Framework analysis: a worked example of a study exploring young people’s experiences of depression. Qual Res Psychol. 2016;13:109–129. doi: 10.1080/14780887.2015.1119228.
    1. Sigvant B, Lundin F, Wahlberg E. The risk of disease progression in peripheral arterial disease is higher than expected: a meta-analysis of mortality and disease progression in peripheral arterial disease. Eur. J. Vasc. Endovasc. Surg. 2016;51:395–403. doi: 10.1016/j.ejvs.2015.10.022.
    1. Rantner B, Kollerits B, Pohlhammer J, Stadler M, Lamina C, Peric S, et al. The fate of patients with intermittent claudication in the 21st century revisited — results from the CAVASIC Study. Sci Rep. 2017;8:45833. doi: 10.1038/srep45833.
    1. Cambou JP, Aboyans V, Constans J, Lacroix P, Dentans C, Bura A. Characteristics and outcome of patients hospitalised for lower extremity peripheral artery disease in France: the COPART Registry. Eur J Vasc Endovasc Surg. 2010;39:577–585. doi: 10.1016/j.ejvs.2010.02.009.
    1. Vaartjes I, de Borst GJ, Reitsma JB, de Bruin A, Moll FL, Grobbee DE, et al. Long-term survival after initial hospital admission for peripheral arterial disease in the lower extremities. BMC Cardiovasc Disord. 2009;9:43. doi: 10.1186/1471-2261-9-43.
    1. Abaraogu U, Ezenwankwo E, Dall P, Tew G, Stuart W, Brittenden J, et al. Barriers and enablers to walking in individuals with intermittent claudication: a systematic review to conceptualize a relevant and patient-centered program. PLOS One. 2018;13:e0201095. doi: 10.1371/journal.pone.0201095.
    1. Abaraogu UO, Ezenwankwo EF, Dall PM, Seenan CA. Living a burdensome and demanding life: a qualitative systematic review of the patients experiences of peripheral arterial disease. PLOS One. 2018;13:e0207456. doi: 10.1371/journal.pone.0207456.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.

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