Pilot study for the evaluation of a combined psycho- and physiotherapeutic treatment program for patients with chronic pelvic pain syndrome (CPPS)

• Register: ISRCTN
• Last refreshed on: 27 December 2021
• Main ID: ISRCTN43221600
• Date of registration: 10/05/2016
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Hamburg
• Public title: Pilot study for the evaluation of a combined psycho- and physiotherapeutic treatment program for patients with chronic pelvic pain syndrome (CPPS)
• 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)“
• Date of first enrolment: 23/05/2016
• Target sample size: 54
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN43221600
• Study type: Interventional
• Study design: Interventional single-centre crossover design with a control group (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Christian A. Bruenahl

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Substance dependence
2. Delusional disorder

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic pelvic pain syndrome (CPPS) .
Musculoskeletal Diseases

Intervention(s)

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.

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

N/A

Source(s) of Monetary Support

PRANA Foundation/ PRANA-Stiftung im Stifterverband für die Deutsche Wissenschaft

Ethics review

Status:
Approval date:
Contact:

Ethics Board of the Medical Association of Hamburg, 02/12/2014, ref: PV4801

Results

• Results available: Yes
• Date Completed: 31/01/2018