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Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects

Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01701427
Acronym
HADES-1
Enrollment
21
Registered
2012-10-05
Start date
2012-06-30
Completion date
2013-01-31
Last updated
2013-01-07

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

Conditions

Persistent Postherniotomy Pain

Keywords

Hyperalgesia, Persistent pain, deep pain, electrical stimulation, groin hernia

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

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in skin pain detection threshold before and during deep electrical pain stimulation.14 daysHeat 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

MeasureTime frameDescription
Test-retest of primary outcome14 daysThe primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.

Other

MeasureTime frameDescription
deep electrical and pain detection thresholds14 daysThe detection- and pain detection thresholds to electrical stimulation will be assessed. An up-n-down staircase stimulation of single oulses of 0.04 mSeconds with increasing mA from 0.1 to a maximum of 60 mA is used. A total of 10 thresholds is recorded in the following locations. Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation. Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation. External inguinal ring - subcutaneous and funicle stimulation. Musculus rectus abdominis sin. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.
warmth and mechanical detection and pain detection thresholds14 dayswarmth and mechanical detection and pain detection thresholds are recorded in the right and left groin and right lower arm. A total of 10 repated mesures for each parameter is recorded.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026