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Completed

NCT Number: NCT01701427

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

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

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Key information

Conditions

Persistent Postherniotomy Pain Hernia Hernia, Abdominal Hernia, Inguinal Hyperalgesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Section for Surgical Pathophysiology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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:

    • 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.

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects

Acronym: HADES-1

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Oct 5, 2012
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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