Effect of transcutaneous electrical nerve stimulation (TENS) therapy on walking performance in patients with peripheral arterial disease

Effect of TENS on walking performance in patients with peripheral arterial disease

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001143213

Enrollment

Registered

2018-07-12

Start date

2018-07-23

Completion date

2018-09-30

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Transcutaneous electrical nerve stimulation (TENS) is recognised as a safe, effective and non-invasive method of pain relief that works via stimulation of sensory fibres. Several studies have identified that TENS can significantly reduce exercise induced pain. Given that exercise-induced leg pain is a major barrier to physical activity for patients with peripheral artery diease and intermittent claudication (PAD-IC), further investigation of the benefits of TENS application for these patients could identify a simple therapy to reduce the pain associated with physical activity. The aim of this project is to examine the influence of TENS on walking capacity (via 6-minute walking test) in PAD-IC patients. Identification of a simple therapy to increase walking capacity will enhance patient mobility and independence that may contribute to improved levels of physical activity, quality of life and subsequent physical health.

Interventions

Application of transcutaneous electrical nerve stimulation (TENS, ~120Hz & 180µs) to PAD-affected lower limb (ie gastrocnemius) of patient prior to (20-minutes) and during the entire 6-minute wallking test by an accredited exercise physiologist. Application of transcutaneous electrical nerve stimulation (TENS) unit that does not work (Sham) to PAD-affected lower limb (ie gastrocnemius) of patient prior to (20-minutes) and during the entire 6-minute wallking test by an accredited exercise physiol

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- clinical diagnosis of PAD by general practitioner (GP) or vascular specialist - history of intermittent claudication. - ankle-brachial index of <0.9; - free of any lower limb condition/s that severely limits their walking ability

Exclusion criteria

- unstable cardiovascular or respiratory conditions that contradict safe performance of exercise (ie 6-minute walking test.)

Outcome results