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

NCT ID: NCT02042651

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low intensity extracorporeal shockwave therapy

Active treatment with low intensity extracorporeal shockwave therapy applied to the perineum.

Group Type: EXPERIMENTAL

Low intensity extracorporeal shockwave therapy

Intervention Type: DEVICE

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

Sham low intensity extracorporeal shockwave therapy

Sham treatment with low intensity extracorporeal shockwave therapy applied to the perineum.

Group Type: SHAM_COMPARATOR

Sham low intensity extracorporeal shockwave therapy

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Storz Duolith® SD1 T-TOP, CE 1275; Storz Duolith® SD1 T-TOP, CE 1275

Eligibility Criteria

Inclusion Criteria

• pelvic pain with a duration of more than 6 months
• be able to read and understand the study information

Exclusion Criteria

• known etiology for pelvic pain eg. cancer, infection, inherent abnormalities.
• diagnosed with hemophilia
• receiving anti thrombotic therapy other than hearth magnyl
• diagnosed with thrombocytosis
• active cancer
• treated with IV glucocorticoids within the last 6 months
• disease in the rectal area
• abnormal digital rectal exploration
• bacteriospermia

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Frey

Junior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders U Frey, Bach. Med.

Role: PRINCIPAL_INVESTIGATOR

Urological Research Unit, Herlev Hospital

Locations

Birthe bonde klinikken

Copenhagen E, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

HEH-2013-33

Identifier Type: OTHER

Identifier Source: secondary_id

H-3-2013-178

Identifier Type: -

Identifier Source: org_study_id