Persistent Postherniotomy PainHADES-1NCT01701427
Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects
An observational study of Persistent Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Persistent Postherniotomy Pain
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy young men.
Who may be able to join
- male, age >18 yr, pain-free, caucasian
Who cannot join
- previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section for Surgical Pathophysiology, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Hyperalgesia After Deep Electrical Stimulation 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
- Conditions
- Persistent Postherniotomy Pain
- Keywords
- Hyperalgesia, Persistent pain, deep pain, electrical stimulation, groin hernia
- Medical subject headings
- Hyperalgesia, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin pain detection threshold before and during deep electrical pain stimulation.
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.
Measured: 14 days
Secondary outcomes (1)
Test-retest of primary outcome
The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Postherniotomy PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701427
- Sponsor's protocol ID
- H-1-2012-035
- Acronym
- HADES-1
- Status last verified
- Jan 2013
- First submitted
- 3 Oct 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasvang EK, Werner MU, Kehlet H. Referred pain and cutaneous responses from deep tissue electrical pain stimulation in the groin. Br J Anaesth. 2015 Aug;115(2):294-301. doi: 10.1093/bja/aev170. Epub 2015 Jun 12.
PubMed 26071091
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects
- ClinicalTrials.gov ID
- NCT01701427
- Acronym / sponsor ID
- HADES-1 / H-1-2012-035
- Conditions
- Persistent Postherniotomy Pain
- Keywords
- Hyperalgesia, Persistent pain, deep pain, electrical stimulation, groin hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy young men.
Key inclusion criteria (1 listed)
- male, age >18 yr, pain-free, caucasian
Key exclusion criteria (1 listed)
- previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Test-retest of primary outcome
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Derived from this study: PubMed 26071091Aasvang EK, Werner MU, Kehlet H. Referred pain and cutaneous responses from deep tissue electrical pain stimulation in the groin. Br J Anaesth. 2015 Aug;115(2):294-301. doi: 10.1093/bja/aev170. Epub 2015 Jun 12.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin pain detection threshold before and during deep electrical pain stimulation. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01701427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.