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Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects (HADES-1)

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ClinicalTrials.gov Identifier: NCT01701427
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark

Study Description
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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

Condition or disease
Persistent Postherniotomy Pain

Study Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013
Groups and Cohorts
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Group/Cohort
1
1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Test-retest of primary outcome [ Time Frame: 14 days ]
    The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.


Other Outcome Measures:
  1. deep electrical and pain detection thresholds [ Time Frame: 14 days ]

    The 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.


  2. warmth and mechanical detection and pain detection thresholds [ Time Frame: 14 days ]
    warmth 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young men.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701427


Locations
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Denmark
Section for Surgical Pathophysiology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01701427    
Other Study ID Numbers: H-1-2012-035
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Keywords provided by Eske Kvanner Aasvang, Rigshospitalet, Denmark:
Hyperalgesia
Persistent pain
deep pain
electrical stimulation
groin hernia
Additional relevant MeSH terms:
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Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases