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The effect of spinal cord stimulation and dorsal root ganglion stimulation on histamine induced itch: an experimental pilot study

The effect of spinal cord stimulation and dorsal root ganglion stimulation on histamine induced itch: an experimental pilot study - SCS in itch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49164
Enrollment
12
Registered
2020-05-15
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

experimentele pruritus experimental pruritus itch

Interventions

After switching off the SCS or DRGS, histamine will be applied percutaneously to a healthy area of skin innervated by the neurostimulator, as well as to a healthy area of skin not innervated by the

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Good effect (>= 50% decrease of pain) of spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRGS) treatment. - The area innervated by the SCS or DRGS must extend to a healthy, pain-free, uninterrupted area of skin of at least 10x20cm - Contralaterally, an equal, uninterrupted, healthy area of skin must be available; this must not be innervated by the stimulator. - Patient must have no objections against switching off his or her device, for up to one hour. - Age >=18 years - No ongoing itch perception

Exclusion criteria

Exclusion criteria: - Generalized skin disorder, - Systemic disease associated with pruritus, - Complex regional pain syndrome - Allergy or hypersensitivity - Contra-indication for histamine administration, such as mastocytosis - Use of opioids - Use of oral antihistamines, corticosteroids or other (immunosuppressive) drugs that might prevent potential participants from developing a flare.

Design outcomes

Primary

MeasureTime frame
Itch intensity will be recorded using a visual analog scale (VAS). Patients* VAS score will be noted at baseline, after switching off of the neurostimulator, 15 minutes after application of histamine, and 1, 5, 10, 15 and 30 minutes after the stimulator has been switched on. All measurements will be noted for both sides, separately.

Secondary

MeasureTime frame
The size of the flare will be measured at all timepoints after application of histamine. At all timepoints after histamine application, character and variance of itch perception will be determined, by means of a questionnaire. All measurements will be noted for both sides, separately.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)