Persistent Pain After Open Inguinal HerniotomyNCT01768130
Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy
An observational study of Persistent Pain After Open Inguinal Herniotomy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Pain After Open Inguinal Herniotomy
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with persistent pain after open inguinal herniotomy
Who may be able to join
- Patients with persistent pain after open inguinal herniotomy
- Age > 18 years
Who cannot join
- Cognitive impairment
- Drug or alcohol abuse
- Bilateral inguinal hernia operation
- Nerve injury from other causes
Trial locations and contacts
1 site in 1 country.
About this study
The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.
What is being measured
The primary outcome is the main question the study is designed to answer.
Test- retest variability of thermal thresholds.
Analysis of agreement (Bland-Altman) and reliability (intraclass correlation coefficients) of thermal threshold test- retest data assessed at baseline and after 4-6 weeks.
Measured: At baseline and retest 4-6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pain After Open Inguinal HerniotomyStudies 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, Joakim Bischoff, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768130
- Sponsor's protocol ID
- H-2-2011-023
- Status last verified
- Feb 2014
- First submitted
- 7 Jan 2013
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Thermal Thresholds in Patients With Persistent Pain After Open Inguinal Herniotomy
- ClinicalTrials.gov ID
- NCT01768130
- Acronym / sponsor ID
- H-2-2011-023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jan 2013 (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.
The study will investigate the test-retest variability of thermal thresholds in patients with persistent pain after open inguinal herniotomy. Sensory mapping with a cool metal roller delineated an area with cool sensory dysfunction on the painful site. In this area and in a contralateral area as a control, 5 sites were outlined, including the point of maximum pain. In these total 10 sites warmth detection threshold (WDT), cool detection threshold (CDT) and heat pain threshold (HPT) were assessed using quantitative sensory testing. Tests were repeated after a 4-6 weeks interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with persistent pain after open inguinal herniotomy
Key inclusion criteria (2 listed)
- Patients with persistent pain after open inguinal herniotomy
- Age > 18 years
Key exclusion criteria (4 listed)
- Cognitive impairment
- Drug or alcohol abuse
- Bilateral inguinal hernia operation
- Nerve injury from other causes
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
Test- retest variability of thermal thresholds.
Time frame: At baseline and retest 4-6 weeks later
Analysis of agreement (Bland-Altman) and reliability (intraclass correlation coefficients) of thermal threshold test- retest data assessed at baseline and after 4-6 weeks.
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 28 Feb 2014.
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 Pain After Open Inguinal Herniotomy, 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 2 inclusion and 4 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 28 Feb 2014. 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?
Test- retest variability of thermal thresholds. (time frame: At baseline and retest 4-6 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2014.