NCT01802528

Brief Summary

Obturator externus (OE) muscle has the possibility as a pain generator, considering its anatomical and functional aspects, but this muscle as a possible target for therapeutic intervention is currently understudied in pain practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

9 months

First QC Date

February 27, 2013

Last Update Submit

February 27, 2013

Conditions

Chronic Pelvic Pain

Keywords

obturator externus

Outcome Measures

Primary Outcomes (1)

  • Post-injection pain score

    Before and after the OE muscle injection, patients were asked to rate their pain score using a 10-point numeric rating scale (NRS; 0=no pain, 10=worst possible pain). We also assessed the degree of patient satisfaction as excellent, good, fair, and bad during 2 weeks after injection. In this period, any analgesic medications did not change in all patients. Complications associated with OE muscle injection were investigated.

    at 2 weeks after injection

Study Arms (1)

Obturator externus muscle injection

patients were treated with obturator externus injection

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was defined as chronic pelvic pain patients with a localized tenderness on inferolateral side of the pubic tubercle corresponding to obturator foramen who received OE muscle injection with local anesthetic for their pain treatment.

You may qualify if:

  • \. 20-75 adults/ 2. Chronic pelvic pain patients who required the interventional procedures/ 3. patients with a localized tenderness on inferolateral side of the pubic tubercle

You may not qualify if:

  • \. Severe cardiovascular disease /2. Coagulation abnormality /3. Patient denial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute,

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

KR(1)