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

Completed

• Conditions: Persistent Postherniotomy Pain

• Registration Number: NCT01701427
• Lead Sponsor: Rigshospitalet, Denmark

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2012-12
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in skin pain detection threshold before and during deep electrical pain stimulation.	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 Outcome Measures

Name	Time	Method
Test-retest of primary outcome	14 days	The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.

Trial Locations

Locations (1)

Section for Surgical Pathophysiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark