Chronic Pelvic PainNCT01020162
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
A study testing Amitryptiline, gabapentin and Resection of the ilioinguinal nerve in people with Chronic Pelvic Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. Read more about this study
- Who is it for?
- Ages 15 to 70 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Amitryptiline, gabapentin and Resection of the ilioinguinal nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Sep 1995to Nov 2007
- Phase
- Interventional
- 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 15 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment
Who cannot join
- Drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Amitryptiline, gabapentin, Resection of the ilioinguinal nerve
- Keywords
- Chronic pelvic pain, ilioinguinal nerve entrapment, randomized study, Chronic pelvic pain in women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amitryptiline, gabapentinDrug
Also called Amitryptiline - Saroten, Gabapentin - Neurontin
For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.
Resection of the ilioinguinal nerveProcedure or surgery
In general anaesthesia the nerve was identified and resected as central as possible
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical | Active comparator | TENS, amitriptyline, gabapentin. Receives: Drug: Amitryptiline, gabapentin |
| Surgical intervention | Active comparator | Resection of the ilioinguinal nerve Receives: Procedure: Resection of the ilioinguinal nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.
Measured: At least one year after intervention,in some cases more then five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startSep 1995
- Primary completionDec 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Ian Milsom, MD,PhD, Study chair, Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020162
- Sponsor's protocol ID
- 429-05
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01020162
- Acronym / sponsor ID
- 429-05
- Conditions
- Chronic Pelvic Pain
- Keywords
- Chronic pelvic pain, ilioinguinal nerve entrapment, randomized study, Chronic pelvic pain in women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Sep 1995
- Primary completion
- Dec 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Nov 2009 (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.
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical | Active comparator | Drug: Amitryptiline, gabapentinTENS, amitriptyline, gabapentin. |
| Surgical intervention | Active comparator | Procedure: Resection of the ilioinguinal nerveResection of the ilioinguinal nerve |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment
Key exclusion criteria (1 listed)
- Drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amitryptiline, gabapentinAlso: Amitryptiline - Saroten, Gabapentin - NeurontinFor amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid. | Drug | Non-surgical |
| Resection of the ilioinguinal nerveIn general anaesthesia the nerve was identified and resected as central as possible | Procedure or surgery | Surgical intervention |
Primary outcome
Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.
Time frame: At least one year after intervention,in some cases more then five years.
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 25 Nov 2009.
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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.
Ian Milsom, MD,PhD study chair
Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitryptiline, gabapentin and Resection of the ilioinguinal nerve in people with Chronic Pelvic Pain, run by Göteborg University at 1 site in Sweden.
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 25 Nov 2009. 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 Sweden. 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?
Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales. (time frame: At least one year after intervention,in some cases more then five years.). 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 25 Nov 2009.