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Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID) (PrEPAID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204825
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
NHS Greater Glasgow and Clyde
University of Glasgow
Northumbria University
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
Glasgow Caledonian University

Brief Summary:
Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise and physical activity (PA) are central to the management of PAD and help to improve walking distances and reduce the risks associated with PAD such as heart attack and stroke. However, exercise and PA in this population is often limited due to pain. Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase walking distance in patients with PAD. Investigators have also shown that educating patients about their condition and helping them to set goals has the potential to increase PA, and quality of life. This study will examine the feasibility of designing a definitive trial that investigates whether TENS can improve the physical activity of patients with PAD when delivered alone and/or alongside a patient education programme.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Intermittent Claudication Device: Active TENS Behavioral: Patient-Centred Education Device: Placebo TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2x2 randomised feasibility controlled trial blinded for primary outcome
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Primary outcome assessors will be blinded for patient group allocation
Primary Purpose: Other
Official Title: Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID): Feasibility Randomised Controlled Trial
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active TENS
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Device: Active TENS
TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Other Names:
  • TENS
  • TNS
  • Transcutaneous Nerve Stimulation
  • Transcutaneous Electrical Nerve Stimulation

Placebo Comparator: Placebo TENS
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Device: Placebo TENS
TENS device use with setting so that the stimulation delivered is ineffective
Other Names:
  • P-TENS
  • Placebo Transcutaneous Electrical Nerve Stimulation

Experimental: Patient-Centred Education
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Behavioral: Patient-Centred Education
Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Other Names:
  • Education
  • SEDRIC
  • Structured patient-centred education intervention

Experimental: Patient-Centred Education + Active TENS
Combination of Patient-Centred Education arm and Active TENS arm.
Device: Active TENS
TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Other Names:
  • TENS
  • TNS
  • Transcutaneous Nerve Stimulation
  • Transcutaneous Electrical Nerve Stimulation

Behavioral: Patient-Centred Education
Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Other Names:
  • Education
  • SEDRIC
  • Structured patient-centred education intervention




Primary Outcome Measures :
  1. Change in Absolute Claudication Distance (ACD) in meters from baseline [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Maximal walking distance on graded treadmill test

  2. Recruitment rates [ Time Frame: End of study (18 weeks) ]
    Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log

  3. Participant retention rate [ Time Frame: End of study (18 weeks) ]
    Ratio of patients who completed the intervention and outcome assessment to the patient who consented

  4. Adverse events [ Time Frame: End of study (18 weeks) ]
    Record defined adverse events in all groups

  5. Uptake of interventions [ Time Frame: End of study (18 weeks) ]
    Measure uptake of intervention via log of TENS use and attendance at education session and follow up phone calls

  6. Qualitative analysis of participant experience of trial [ Time Frame: End of study (18 weeks) ]
    Analysis of focus group discussions with participants regarding experience of trial and interventions


Secondary Outcome Measures :
  1. Change in Initial Claudication Distance (ICD) in meters from baseline [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Onset distance of claudication pain on graded treadmill test

  2. Change in daily physical activity [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Total number of steps (activpal step counts)

  3. Change in daily physical activity [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Total number of upright events (activpal upright even count)

  4. Change in daily physical activity [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Total number of walking events (activpal walking event counts)

  5. Change in daily physical activity [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Event-based claudication index (ratio of walking events to upright events) participants undertake in a day.

  6. Intermittent Claudication Questionnaire (ICQ) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Disease specific quality of life questionnaire

  7. Short-Form 36 Questionnaire [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Generic quality of life questionnaire

  8. McGill Pain Questionnaire (MPQ) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Pain quality questionnaire

  9. Visual Analogue Scale (VAS) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Average Pain intensity in the past 7 days

  10. Illness Perception Questionnaire (IPQ) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Illness beliefs questionnaire

  11. Geriatric Depression Scale (Short Form) (GDS-SF) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Depression questionnaire

  12. Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    Measure of pain intensity

  13. Blood biomarkers (optional) [ Time Frame: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up) ]
    20mls of blood will be taken from rested subjects, spun and stored for future analysis of markers of angiogenesis and inflammatory response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting Ankle Brachial Pressure Index (ABPI) <0.9 in at least one leg
  • Stable IC for ≥3 months
  • Walking limited primarily by claudication
  • Able to exercise on a treadmill
  • Able to read and speak English to a level allowing satisfactory completion of the study procedures
  • Able to provide written informed consent for participation

Exclusion Criteria:

  • Planned surgical or endovascular intervention for PAD within the next 3 months
  • Critical limb ischaemia
  • The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
  • Previous experience of using TENS/ structured patient education for PAD
  • Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently.
  • Patients who require walking aids including artificial limbs
  • Major surgery, myocardial infarction or stroke/ Transient Ischaemic Attack (TIA) in the previous 6 months
  • Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis)
  • >20% variation in baseline ACD on treadmill
  • Severe peripheral neuropathies above the ankle.
  • Participation in another research protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204825


Locations
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United Kingdom
Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, Strathcylde, United Kingdom, G51 4TF
Sponsors and Collaborators
Glasgow Caledonian University
NHS Greater Glasgow and Clyde
University of Glasgow
Northumbria University
Chief Scientist Office of the Scottish Government
Investigators
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Study Director: Chris Seenan, PT, PhD Glasgow Caledonian University
Principal Investigator: UKACHUKWU ABARAOGU, MSc, PT Glasgow Caledonian University
Study Chair: Julie Brittenden, MD, FRCS Queen Elizabeth University Hospital/University of Glasgow
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT03204825    
Other Study ID Numbers: 16 044
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glasgow Caledonian University:
Patient education
Pain management
Transcutaneous electrical nerve stimulation
Physical activity
Feasibility
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases