Plain English Summary
Background and study aims
Although Chronic Pelvic Pain Syndrome (CPPS) is a severe illness suffered by a notable amount of patients, little is known about its causes. Two new treatments have recently been developed - in the USA and Canada – both having psychological and physiotherapeutic elements. Results for both have been promising so far. However, until now, both methods have only been tested separately and only with male patients. In this study, the feasibility of both approaches will be examined together and with both female and male patients. The researchers also want to find out whether there are things than can be improved upon.
Who can participate?
Patients who suffer from CPPS, have visited the specialized outpatient clinic for CPPS at the University Medical Center Hamburg, and whose quality of life is impaired.
What does the study involve?
Participants are randomly allocated to one of 4 same-sex groups.. One group of female patients and one group of male patients first receive psychotherapy followed by physiotherapy. The other two groups receive physiotherapy only. The psychotherapeutic module involves 9 group sessions led by two experienced therapists. In these sessions, patients learn how to reduce catastrophizing thoughts, how to deal with behavioral and social aspects of CPPS and how to improve everyday activities. In the course of this module, they get to know and try out new coping strategies. The physiotherapeutic module involves 9 sessions in both single and group settings. It includes techniques for self-perception and relaxation as well as elements of respiratory and heat therapy. All participants are asked to fill out questionnaires regarding their physical and emotional well-being therapy at 6 time points. Participants are also investigated by a physiotherapist before each module and four weeks after the last module. Furthermore, the researchers will assess a group of patients that act as controls that cannot take part in the therapy due to their places of residence.
What are the possible benefits and risks of participating?
Participation in this study may increase the quality of life of participants and reduce their pain. There are no significant risks of taking part; some participants may find the therapy distressing or the therapy may not work for them. In these cases, they can approach the experienced therapists who accompany the study.
Where is the study run from?
Department of Psychosomatic Medicine and Psychotherapy , University Medical Center Hamburg (Germany).
When is the study starting and how long is it expected to run for?
January 2015 to December 2016
Who is funding the study?
the PRANA Foundation.
Who is the main contact?
Dr. Christian A. Brünahl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pilot study for the evaluation of the feasibility and the efficacy of a combined cognitive-behavioral and physiotherapeutic treatment program for patients with chronic pelvic pain syndrome (CPPS) within the context of the "Interdisciplinary Research Platform, Chronic Pelvic Pain Syndrome (CPPS)“
Acronym
COMBI-CPPS
Study hypothesis
Hypothesis 1: Health-related quality of life as measured by the SF-12 will have improved after treatment, either in the physical or the mental domain.
Hypothesis 2: Symptom severity as measured by the NIH-CPSI will have decreased after treatment.
Hypothesis 3: Catastrophizing cognitions concerning pain as measured by the PCS, depressiveness (PHQ-9), anxiety (GAD-7), general somatic symptoms (PHQ-15), perceived stress (PSQ), as well as the number of trigger points will have decreased.
Ethics approval
Ethics Board of the Medical Association of Hamburg, 02/12/2014, ref: PV4801
Study design
Interventional single-centre crossover design with a control group
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Chronic pelvic pain syndrome (CPPS) .
Intervention
Based on the “Cohort Multiple Randomized Controlled Trial” design, patients will be recruited from an interdisciplinary outpatient clinic for CPPS at the University Medical Center Hamburg. Assignment to the treatment and control groups will not be randomized, but will be defined by the ability to participate regularly at the place of treatment.
The treatment group will receive two successive treatment modules, each comprising nine weeks. The psychotherapeutic module is based on the preliminary work of a Canadian research group and consists of a cognitive-behavioral short-term intervention in groups. The physiotherapeutic module is based on the preliminary work of a work group from the USA and will take place both in individual and group settings. Following a cross-over design, one female and one male patient group each will be assigned to one of two sequences of the treatment modules.
The control group will consist of 18 patients who will not be able to participate in the therapy due to their place of residence and who will receive treatment as usual.
Data from 7 points of time before, during and after treatment as well as in comparison to the control group will be analyzed.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Health-related quality of life (SF-12); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
Secondary outcome measures
1. Symptom severity (National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
2. Pain perception (Short-Form McGill Pain Questionnaire, SF-MPQ); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
3. Pain-related disability (Pain Disability Index, PDI); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
4. Catastrophizing cognitions (Pain Catastrophizing Scale, PCS); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
5. Depressive symptom severity (Patient Health Questionnaire depression module, PHQ-9); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
6. Generic somatic symptom severity (Patient Health Questionnaire Somatization module, PHQ-15); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
7.Anxiety symptom severity (Generalized Anxiety Disorder 7-item scale, GAD-7); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
8. Perceived stress (Perceived Stress Questionnaire, PSQ); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
9. Utilization of the health care system (proprietary questionnaire); 7 times of measurement: at the time of visiting the outpatient clinic, at the time of inclusion, before and after each treatment module as well as four weeks after the overall treatment
10. Physiotherapeutic examination of trigger and tender points; prior to the first and prior to the second treatment module as well as four weeks after the overall treatment
11. Goal attainment (GAS): directly after the physiotherapeutic module and four weeks after overall treatment (added 13/05/2016)
12. Satisfaction with the treatment (proprietary questionnaire); before the second module as well as four weeks after the overall treatment
Removed outcomes:
11. Goal attainment (GAS): after each module and four weeks after overall treatment
13. Selective attention on pain-related stimuli, measured by a computer-based dot-probe-task; 3 times of measurement: before the psychotherapeutic module, directly after the psychotherapeutic module and 4 weeks after the psychotherapeutic module (added 13/05/2016)
Overall trial start date
01/01/2015
Overall trial end date
20/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. A diagnosis of CPPS
2. A score ≤ 40 either in the mental or the physical scale of the SF-12
3. Sufficient knowledge of the German language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54
Participant exclusion criteria
1. Substance dependence
2. Delusional disorder
Recruitment start date
23/05/2016
Recruitment end date
15/06/2017
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center Hamburg
Martinistraße 52
Hamburg
20246
Germany
Funders
Funder type
Charity
Funder name
PRANA Foundation/ PRANA-Stiftung im Stifterverband für die Deutsche Wissenschaft
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. A study protocol will be disseminated in an international peer reviewed scientific journal and presented in national and international conference talks
2. The results will be presented in an international peer reviewed scientific journal and presented in national and international conference talks
3. The results will be used to plan and conduct a randomized controlled trial (RCT)
Intention to publish date
19/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary