Chronic Pelvic Pain in Females and Males

Sponsor

Salem Anaesthesia Pain Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT06102733

Collaborator

(none)

1,000

Enrollment

Location

83.9

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain Syndrome Sacroiliac Disorder Piriformis Syndrome Sacrococcygeal Disorder Inguinal Hernia	Behavioral: Rehabilitation therapy

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

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Chronic Pelvic Pain Management in Female and Male Adult Patients

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Adult chronic pain patients Adult chronic pain patients with pelvic, inguinal or sacroiliac pain	Behavioral: Rehabilitation therapy Chronic pain rehabilitation therapy

Arm

Intervention/Treatment

Adult chronic pain patients

Adult chronic pain patients with pelvic, inguinal or sacroiliac pain

Behavioral: Rehabilitation therapy

Chronic pain rehabilitation therapy

Outcome Measures

Primary Outcome Measures

Pain score, objective measurement using the validated Numeric Pain Rating scale [12 months]
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with chronic pelvic pain
Patients with sacroiliac pain
Patients with inguinal pain
Patients with coccygeal pain
Patients with piriformis pain

Exclusion Criteria:

Patients with spinal pain
Patients who had spine surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salem Anaesthesia Pain Clinic	Surrey	British Columbia	Canada	V3S 7J1

Sponsors and Collaborators

Salem Anaesthesia Pain Clinic

Investigators

Principal Investigator: Olumuyiwa Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salem Anaesthesia Pain Clinic

ClinicalTrials.gov Identifier:

NCT06102733

Other Study ID Numbers:

SalemAne2018 Pelvic Pain WoMen

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Salem Anaesthesia Pain Clinic

Pelvic pain

Additional relevant MeSH terms:

Piriformis Muscle Syndrome

Syndrome

Hernia, Inguinal

Pelvic Pain

Study Results

No Results Posted as of Oct 26, 2023