MedTrace Logo

A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain

NCT02042651 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-03-24

No results posted yet for this study

Summary

Introduction:

Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.

Methods:

All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.

The investigators anticipate to include 100 chronic pelvic pain patients in the study.

included patients will be randomized into two groups: active treatment or sham treatment.

All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.

A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.

Participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment.

Possible gains from this study:

The investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today.

Ethics, funding, and publication:

The study is performed in compliance with the Helsinki declaration. External funding have been applied for but not yet received. Participants will be informed of sources of external funding. The result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.

Conditions

  • Chronic Pelvic Pain

Interventions

DEVICE

Low intensity extracorporeal shockwave therapy

Shockwaves will be applied to the perineum a total of 6 times once per week. The energy level applied will range between 0.25 and 0.40 mJ/mm2 with a frequency of 3 Hz for a total of 3000 shockwaves per treatment session

DEVICE

Sham low intensity extracorporeal shockwave therapy

Shockwaves will be applied to the perineum a total of 6 times once per week. The shockwaves will be blocked by a medium on the handheld applicator.

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Anders U Frey, Bach. Med. · Urological Research Unit, Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Denmark

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042651 on ClinicalTrials.gov