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Clinical Trials/NCT01701427
NCT01701427CompletedNot Applicable

Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects

Rigshospitalet, Denmark1 site in 1 country21 target enrollmentStarted: June 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Change in skin pain detection threshold before and during deep electrical pain stimulation.

Study Overview

Brief Summary

Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper structures as well as the skin. Whether this is one combined pain syndrome, where for instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical stimulation in deeper tissues in the groin and recording the skin sensory function, this hypothesis will be tested

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • male, age >18 yr, pain-free, caucasian

Exclusion Criteria

  • previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.

Outcomes

Primary Outcomes

Change in skin pain detection threshold before and during deep electrical pain stimulation.

Time Frame: 14 days

Heat pain detection threshold by use of a Thermotester (Somedic AS Sweden) is assessed before and during deep electrical pain stimulation (6 of 10 point on a NRS scale. Deep pain stimulation is performed by two needle electrodes, placed under ultrasound guidance, 5 mm apart in various tissue and locations in the groin: 1. Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation. 2. Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation. 3. External inguinal ring - subcutaneous and funicle stimulation.

Secondary Outcomes

  • Test-retest of primary outcome(14 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eske Kvanner Aasvang

M.D.

Rigshospitalet, Denmark

Study Sites (1)

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