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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Mette Schmidt, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT02042651
First received: January 10, 2014
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Pelvic Pain
Device: Low intensity extracorporeal shockwave therapy
Device: Sham low intensity extracorporeal shockwave therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Change in NIH-Chronic Prostatitis Symptom Index [ Time Frame: Change from baseline to twelve weeks after final treatment ] [ Designated as safety issue: No ]
    A questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain, urinary symptoms, and quality of life.


Secondary Outcome Measures:
  • Change in The International Index of Erectile Function 5 [ Time Frame: Change from baseline to twelve weeks after final treatment ] [ Designated as safety issue: No ]
    Questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 25.

  • Change in The International prostate symptom score [ Time Frame: Change from baseline to twelve weeks after final treatment ] [ Designated as safety issue: No ]
    A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. scores range from 0 to 35.

  • Global satisfaction score [ Time Frame: Twelve weeks after final treatment ] [ Designated as safety issue: No ]
    One question designed to estimate treatment satisfaction on a four point Likert scale.


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low intensity extracorporeal shockwave therapy
Active treatment with low intensity extracorporeal shockwave therapy applied to the perineum.
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
Other Name: Storz Duolith® SD1 T-TOP, CE 1275
Sham Comparator: Sham low intensity extracorporeal shockwave therapy
Sham treatment with low intensity extracorporeal shockwave therapy applied to the perineum.
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.
Other Name: Storz Duolith® SD1 T-TOP, CE 1275

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042651

Contacts
Contact: Anders U Frey, Bach. med. 26846961 ext +45 freyen60@gmail.com
Contact: Mikkel M Fode, MD, PHd 26213800 ext +45 mikkelfode@gmail.com

Locations
Denmark
Birthe bonde klinikken Not yet recruiting
Copenhagen E, Copenhagen, Denmark, 2100
Contact: Birthe Bonde, Physiotherapist    26174268 ext +45    birthebonde@mail.dk   
Contact: Anders U Frey, Bach. Med.    26846961 ext +45    freyen60@gmail.com   
Sub-Investigator: Birthe Bonde, Physiotherapist         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Anders U Frey, Bach. Med. Urological Research Unit, Herlev Hospital
  More Information

No publications provided

Responsible Party: Mette Schmidt, administrative research assistent, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02042651     History of Changes
Other Study ID Numbers: H-3-2013-178, HEH-2013-33
Study First Received: January 10, 2014
Last Updated: January 20, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
ESWT
Chronic pelvic pain
randomized
sham controlled

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014