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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01701427
First received: October 3, 2012
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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
Persistent Postherniotomy Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in skin pain detection threshold before and during deep electrical pain stimulation. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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:
  • Test-retest of primary outcome [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.


Other Outcome Measures:
  • deep electrical and pain detection thresholds [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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.


  • warmth and mechanical detection and pain detection thresholds [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701427

Locations
Denmark
Section for Surgical Pathophysiology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01701427     History of Changes
Other Study ID Numbers: H-1-2012-035
Study First Received: October 3, 2012
Last Updated: January 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Hyperalgesia
Persistent pain
deep pain
electrical stimulation
groin hernia

ClinicalTrials.gov processed this record on November 25, 2014