Trial document




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  DRKS00009976

Trial Description

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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)“

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Trial Acronym

COMBI-CPPS

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URL of the Trial

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Brief Summary in Lay Language

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 and the factors contributing to its maintenance. Newer studies indicate that the simultaneous view from the perspectives of different medical specialties forms the basis for a successful treatment. In the last years, two new methods with a psychological and a physiotherapeutic approach have been developed in the USA and Canada, and first studies show promising results. However, until now, both methods have only been tested separately and only with male patients. In our study, we will examine the feasibility of both approaches together with both female and male patients. Furthermore, we want to find out whether there are things we can improve in our treatment concept.

Who can participate?
Patients who suffer from CPPS and who 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?
36 patients will be randomly assigned to four same-sex groups. One group of female patients and one group of male patients will first receive psychotherapy followed by physiotherapy, the other two groups will first receive physiotherapy. The psychotherapeutic module will encompass 9 group sessions led by two experienced therapists. In these sessions, patients will 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 will get to know and try out new coping strategies. The physiotherapeutic module will consist of 9 sessions in both single and group settings. It will encompass techniques for self-perception and relaxation as well as elements of respiratory and heat therapy. In order to judge the efficacy of our combined therapy, we will ask the participants to fill out questionnaires regarding their physical and emotional well-being at 6 time points. Participants will also be investigated by a physiotherapist before each module and four weeks after the last module. Furthermore, we will examine the course of the complaints of 18 patients who will not be able to participate 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 the 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?
The study is run by Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center Hamburg (Germany). All therapeutic sessions will also take place at the University Medical Center Hamburg.

When is the study starting and how long is it expected to run for?
Recruitment will start in March 2016; the therapy itself will start in June 2016 and run till December 2016.

Who is funding the study?
This study is funded by the PRANA Foundation.

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Brief Summary in Scientific Language

The aims of this pilot study are the evaluation of the feasibility as well as the estimation of the effect sizes of an interdisciplinary treatment for patients with Chronic Pelvic Pain Syndrome (CPPS). 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 following inclusion criteria were defined: a diagnosis of CPPS without explaining somatic pathology, sufficient knowledge of the German language, the absence of substance-related disorders or delusional disorders and a score ≤ 40 either in the mental or the physical scale of health-related quality of life (SF-12).
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 work group from the USA and will take place both in individual and group settings. A total of n=36 patients will be treated in four gender-homogeneous groups. 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. Data from 7 points of time before, during and after treatment as well as in comparison to an untreated group (n=18) will be analyzed.
The study is embedded in an already implemented interdisciplinary research platform for CPPS including a specialized interdisciplinary outpatient clinic. The aim of the related existing projects is a better understanding of patients with CPPS and the development of provisions of care for this patient group. This pilot study constitutes an important component for the preparation of a randomized controlled treatment study and will substantially contribute to its quality.

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Organizational Data

  •   DRKS00009976
  •   2016/03/15
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  •   yes
  •   Approved
  •   PV4801, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   CPPS (Chronic Pelvic Pain Syndrome)
  •   F45.4 -  Persistent somatoform pain disorder
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Interventions/Observational Groups

  •   Cognitive-behavioral therapy followed by physiotherapy.

    The manual for the psychotherapeutic intervention was created by our workgroup and is based on the preliminary works of a Canadian work group around Prof. Dr. Dean Tripp, Queens University, Kingston, Canada. The cognitive-behavioral group therapy will be conducted in nine weekly sessions with a length of 90 minutes. Participants will prepare specific tasks prior to each session, (e.g. behavioral analysis, identification of dysfunctional self-communication), which will be explored in depth within the group sessions. Dealing with catastrophizing cognitions, analyzing and changing avoidance behavior and communication patterns in relationships, increasing physical activity and building functional coping strategies will be the focal points of the therapy. As an extension of the manual by Tripp and colleagues, learning and exercising progressive relaxation will be another aspect.

    The physiotherapeutic intervention has been adapted to the psychotherapeutic intervention and will take place in three group sessions with a length of 90 minutes and five individual sessions with a length of 50 minutes. Based on the Wise-Anderson-protocol, it will comprise the following elements: education of the participants about anatomy, the musculoskeletal system and posture, the influence of stress on the muscle tone and the stiffness of the fasciae; the manual treatment of myofascial trigger points; methods to influence the diaphragmatic activity; instruction of the participants in self-treatment and supervision of the self-exercises.

    Between the interventions, there will be a four-week pause.
  •   Physiotherapy followed by cognitive-behavioral therapy; for a description of the modules see "Arm 1"
  •   Control group - treatment as usual
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

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

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Secondary Outcome

Symptom severity (NIH-CPSI), pain perception (SF-MPQ), pain-related disability (PDI), catastrophizing cognitions (PCS), psychological symptom severity (PHQ-9, PHQ-15, GAD-7, PSQ) and utilization of the health care system provided as paper-and-pencil questionnaires; 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 (PDI not measured at time of visiting the outpatient clinic); goal attainment (GAS): after the physiotherapeutic module and four weeks after overall treatment; satisfaction with the treatment: before the second module as well as four weeks after the overall treatment; additionally physiotherapeutic examination before the first and before the second treatment module as well as four weeks after the overall treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/07
  •   54
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Daignosis of CPPS without explaining medical condition, sufficient knowledge of the German language, a score ≤ 40 either in the physical or the mental scale of the SF-12 (health-related quality of life)

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Exclusion Criteria

Substance dependence; delusional disorder

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Addresses

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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med. Dipl.-Psych.  Bernd  Löwe 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dr. med.  Christian A.  Brünahl 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dipl.-Psych.  Christoph  Dybowski 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • PRANA Stiftung im Stifterverband für die Deutsche Wissenschaft e.V.
    • Barkhovenallee 1
    • 45239  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.