Pelvic Pain SyndromeNCT06102733
Chronic Pelvic Pain in Females and Males
An observational study of Pelvic Pain Syndrome and Sacroiliac Disorder, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial summary
Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly. This is a quantitative analysis of prospective clinical data. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain Syndrome, Sacroiliac Disorder, Piriformis Syndrome
- What is being tested?
- Rehabilitation therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with chronic pelvic pain who undergo treatment in pain clinic
Who may be able to join
- Patients with chronic pelvic pain
- Patients with sacroiliac pain
- Patients with inguinal pain
- Patients with coccygeal pain
- Patients with piriformis pain
Who cannot join
- Patients with spinal pain
- Patients who had spine surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olumuyiwa Bamgbade, MD, FRCPC, +17786286600, salem.painclinic@gmail.com
Olu Bamgbade, MD,FRCPC, 17786286600, salem.painclinic@gmail.com
About this study
Official title: Chronic Pelvic Pain Management in Female and Male Adult Patients
Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly.
This is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.
Read the detailed description
Pelvic pain is common, but under-reported in healthy adults. Pelvic pain is reported more commonly in women than in men. Many patients with pelvic pain under-estimate the severity of the problem. Chronic pelvic pain can be managed successfully, if diagnosed properly. Many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain.
This study is a quantitative analysis of prospective clinical data. It is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. This is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.
- Conditions
- Pelvic Pain Syndrome, Sacroiliac Disorder, Piriformis Syndrome, Sacrococcygeal Disorder, Inguinal Hernia
- Being tested
- Rehabilitation therapy
- Keywords
- Pelvic pain
- Medical subject headings
- Piriformis Muscle Syndrome, Hernia, Inguinal, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation therapyBehavioural
Chronic pain rehabilitation therapy
| Study group | Role | What they receive |
|---|---|---|
| Adult chronic pain patients | Adult chronic pain patients with pelvic, inguinal or sacroiliac pain Receives: Behavioral: Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score, objective measurement using the validated Numeric Pain Rating scale
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start2 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Pain SyndromeStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olumuyiwa Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102733
- Sponsor's protocol ID
- SalemAne2018 Pelvic Pain WoMen
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pelvic Pain Management in Female and Male Adult Patients
- ClinicalTrials.gov ID
- NCT06102733
- Acronym / sponsor ID
- SalemAne2018 Pelvic Pain WoMen
- Conditions
- Pelvic Pain Syndrome, Sacroiliac Disorder, Piriformis Syndrome, Sacrococcygeal Disorder, Inguinal Hernia
- Keywords
- Pelvic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- 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.
Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly.
This is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.
Detailed description
Pelvic pain is common, but under-reported in healthy adults. Pelvic pain is reported more commonly in women than in men. Many patients with pelvic pain under-estimate the severity of the problem. Chronic pelvic pain can be managed successfully, if diagnosed properly. Many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain.
This study is a quantitative analysis of prospective clinical data. It is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. This is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult chronic pain patients | – | Behavioral: Rehabilitation therapyAdult chronic pain patients with pelvic, inguinal or sacroiliac pain |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic pelvic pain who undergo treatment in pain clinic
Key inclusion criteria (5 listed)
- Patients with chronic pelvic pain
- Patients with sacroiliac pain
- Patients with inguinal pain
- Patients with coccygeal pain
- Patients with piriformis pain
Key exclusion criteria (2 listed)
- Patients with spinal pain
- Patients who had spine surgery
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 |
|---|---|---|
| Rehabilitation therapyChronic pain rehabilitation therapy | Behavioural | Adult chronic pain patients |
Primary outcome
Pain score, objective measurement using the validated Numeric Pain Rating scale
Time frame: 12 months
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Olumuyiwa Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
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 Pelvic Pain Syndrome and Sacroiliac Disorder, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olumuyiwa Bamgbade, MD,FRCPC (17786286600, salem.painclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score, objective measurement using the validated Numeric Pain Rating scale (time frame: 12 months). 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 27 Jan 2025.