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An experimental test of high frequency electrical stimulation of peripheral nerves for treating chronic pain

A double-blind test of high frequency electrical stimulation of peripheral nerves for treating chronic pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001279415
Enrollment
11
Registered
2016-09-12
Start date
2017-02-10
Completion date
2017-08-17
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Clinical audit data suggests that high frequency electrical stimulation of peripheral nerves is an effective treatment for occipital headaches and chronic pain that develops after peripheral nerve injury. We now wish to investigate effects of this stimulation on pain and sensitivity to painful stimulation in patients with a stimulator implanted along or adjacent to a peripheral nerve. Specifically, we will compare pain and sensitivity to painful stimuli (pressure, sharpness, heat, cold) while the stimulator is switched on and at least 4 hours after the stimulator has been switched off. As stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e., neither the participant nor the investigator will know whether the stimulator is switched on or off).

Interventions

Clinical audit data suggests that high frequency electrical stimulation of peripheral nerves is an effective treatment for occipital headaches and chronic pain that develops after peripheral nerve injury. We now wish to investigate effects of this stimulation on pain and sensitivity to painful stimulation in patients with a stimulator implanted along or adjacent to a peripheral nerve. The implanted stimulator consists of two components: a cylindrical multi-contact electrode wire placed adjacent

Clinical audit data suggests that high frequency electrical stimulation of peripheral nerves is an effective treatment for occipital headaches and chronic pain that develops after peripheral nerve injury. We now wish to investigate effects of this stimulation on pain and sensitivity to painful stimulation in patients with a stimulator implanted along or adjacent to a peripheral nerve. The implanted stimulator consists of two components: a cylindrical multi-contact electrode wire placed adjacent to a peripheral nerve and a rechargeable electrical pulse generator. We will compare pain and sensitivity to painful stimuli (pressure, sharpness, heat, cold) after the stimulator has been switched on or off for 4 hours. As stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e., neither the participant nor the investigator will know whether the stimulator is switched on or off). The pressure-pain threshold will be identified by applying pressure at 100 grams/second to the skin with a pressure sensor (a Wagner Instruments algometer) until the patient reports pain or to a maximum of 5 kg. Patients will rate sharpness between 0 and 10 to the application of a calibrated pin (40 grams force, Neuropen device). Temperature ramps of 1 degree/second will be delivered by a purpose-built Peltier device until the patient reports pain or to limits of 0 and 50 degrees C. These stimuli will be administered by Professor Drummond within the region of pain and at a similar contralateral site while the stimulator is switched off at baseline and four hours after the stimulator has either been switched on or switched off. The washout period between treatments will be at least one week.

Sponsors

Dr Philip Finch
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients who have been implanted with a high frequency electrical nerve stimulator (Nevro stimulator, ARTG Identifier 186043) approximately 2 cm from a peripheral nerve within the past two years will be invited to participate in this study. They will be informed that we wish to investigate the effect of the stimulator on pain.

Exclusion criteria

Patients will be excluded if they have had surgery within the past month at the site of stimulator implantation or if they have any current infection at the site of stimulator implantation or intercurrent infection.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026