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NCT Number: NCT03446027

Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?

Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the management of patients with IC exists, further high quality research is required. This proposed study is vital to identify the contribution of clinical change using NMES, compared to the current gold standard recommended practice of supervised exercise therapy (SET) and, actual standard of care offered in the majority of the UK and Ireland, including best medical therapy (BMT). The device is expected to increase the walking distance in patients with intermittent claudication (IC), and therefore have a benefit on the same when provided in addition to supervised exercise programmes. It is also expected to cause a reduction in pain symptoms and reduced likelihood of major intervention in late stage peripheral arterial disease (PAD). The principal research objective is to assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device as an adjunct to the local standard care that is available at the study randomisation sites, in order to improve walking distance in patients with intermittent claudication (IC).

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust, Bournemouth, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capacity to provide informed consent
  • Aged 18 or above
  • Positive Edinburgh Claudication Questionnaire
  • ABPI <0.9 OR positive stress test (fall in ankle pressure >30mmHg, 40 secs post 1 min treadmill at 10% gradient, 4 km/h)

Exclusion criteria

  • Severe IC requiring invasive intervention as determined by the treating clinician
  • Critical limb Ischaemia as defined by the European Consensus Document
  • Co-morbid disease prohibiting walking on a treadmill or taking part in supervised exercise therapy.
  • Popliteal entrapment syndrome
  • Commenced vascular symptom specific medication in previous 6 months e.g. naftidrofuryl oxalate, cilostazol
  • Pregnancy
  • Any implanted electronic, cardiac or defibrillator device
  • Acute deep vein thrombosis
  • Broken or bleeding skin including leg ulceration
  • Peripheral neuropathy
  • Recent lower limb injury or lower back pain

Treatment and study plan

NMES

Device

NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.

Primary outcomes

  1. Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups

    Time frame: 3 months

    Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months

Secondary outcomes

  1. Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups

    Time frame: 3 months

    Measured by treadmill testing. ICD in meters at baseline and 3 months

  2. Quality of Life - Intermittent Claudication Questionnaire (ICQ)

    Time frame: Baseline, 3 months, 6 months, 12 months

    Patient questionnaire. Used to assess change in disease-specific QoL.

  3. Quality of Life - EuroQoL 5D (EQ5D) Health Scale

    Time frame: Baseline, 3 month, 6 month and 12 months

    Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

  4. Quality of Life Short Form 36 (SF-36) Physical Component Summary

    Time frame: Baseline, 3 month, 6 month and 12 months

    Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

  5. Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months

    Time frame: 3 months

    Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include volume flow (VF, cc/min) to assess whether using the device increases this measurement.

  6. Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months

    Time frame: Baseline, 3 month, 6 month and 12 months

    The single fibre laser optical probe of the LDF machine will be positioned on the dorsal aspect of the foot using single use adhesive pads. Flux, as a measure of superficial skin blood flow will be measured to assess whether using the device increases this measurement.

  7. Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months

    Time frame: Baseline, 3 month, 6 month and 12 months

    The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.

  8. Health Economic Assessment

    Time frame: Baseline, 3 month, 6 month and 12 months

    The economic analyses will compare local therapy (supervised exercise therapy (SET) or exercise advice (EA) only) versus the intervention (local therapy + Neuromuscular Electrical Stimulation, NMES) in patients with Intermittent Claudication. The analyses will be based on a (i) patient level in-trial cost-effectiveness analysis, (ii) a decision model and (iii) budget impact assessment. The in-trial analysis will calculate quality-adjusted life years (QALYs) over the one year time horizon of the trial.

  9. Compliance With Interventions - Exercise Advice (EA)

    Time frame: 3 months

    Comparison of compliance with exercise advice as per local standard of care.

  10. Device Experience Questionnaire - Ease of Use

    Time frame: 3 months

    To report ease of device use and suggest any developments.

  11. Quality of Life - EuroQoL 5D (EQ5D) Health Index

    Time frame: Baseline, 3 months, 6 months, 12 months

    Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

  12. Quality of Life Short Form 36 (SF-36) Mental Component Summary

    Time frame: Baseline, 3 months, 6 months, 12 months

    Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

  13. Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months

    Time frame: 3 months

    Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases this measurement.

  14. Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months

    Time frame: Baseline, 3 months, 6 months and 12 months

    The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.

  15. Compliance With Interventions - Supervised Exercise Therapy (SET)

    Time frame: 3 months

    Comparison of compliance with SET classes.

  16. Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)

    Time frame: 3 months

    Compliance with NMES device. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.

  17. Device Experience Questionnaire - Reduces Leg Pain

    Time frame: 3 months

    To report ease of device use and suggest any developments.

  18. Device Experience Questionnaire - Increased Walk Distance

    Time frame: 3 months

    To report ease of device use and suggest any developments.

  19. Device Experience Questionnaire - Used as Instructed

    Time frame: 3 months

    To report ease of device use and suggest any developments.

  20. Device Experience Questionnaire - Could Have Used More

    Time frame: 3 months

    To report ease of device use and suggest any developments.

  21. Device Experience Questionnaire - Used After Treatment

    Time frame: 3 months

    To report ease of device use and suggest any developments.

Other outcomes

  1. Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites

    Time frame: 3 months

    Subgroup analysis 1: Right censored Tobit regression model for AWD at 3 months to assess the effects SET sites vs non-SET sites (NMES+SET+BMT & SET+BMT vs NMES+BMT & BMT).

  2. Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT)

    Time frame: 3 months

    Subgroup analysis 2: Right censored Tobit Regression model for AWD at 3 months to assess the effects of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).

  3. Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT)

    Time frame: 3 months

    Subgroup analysis 3: Right censored Tobit regression model for the AWD at 3 months to assess the effects of NMES in the non-SET sites (NMES+BMT vs BMT).

  4. Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT)

    Time frame: 3 months

    Subgroup analysis 4: Right censored Tobit regression model for AWD at 3 months to assess the effects of (NMES+BMT) has a similar effect as (SET+BMT).

  5. Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT)

    Time frame: 3 months

    Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

A Multicenter Randomised Controlled Study: Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication (NESIC) Compared to Best Available Treatment?

Acronym: NESIC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2018
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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