Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial.

BACKGROUND: Chronic pelvic pain syndrome (CPPS) is a pain condition perceived in the pelvic area for at least 6 months. While evidence of the aetiology and maintenance of CPPS is still unclear and therapy options are rare, there is preliminary evidence for the efficacy of cognitive behavioural therapy and physiotherapy. However, an integrated treatment has not yet been studied. The primary aim of this study is therefore to test the feasibility of combined psychotherapy and physiotherapy for female and male patients with CPPS. The secondary aim is to explore changes in patient-relevant and economic outcomes compared to a control group.

METHODS: A feasibility study with a crossover design based on the principles of a 'cohort multiple randomized controlled trial' will be conducted to test a combined therapy for patients with CPPS. The study will consist of two consecutive treatment modules (cognitive behavioural group psychotherapy and physiotherapy as individual and group sessions), which will be applied in varying order. The modules will consist of nine weekly sessions with a 4-week break between the modules. The control group will undergo treatment as usual. Study subjects will be recruited from the interdisciplinary outpatient clinic for CPPS at the University Medical Center Hamburg-Eppendorf. Thirty-six patients will be assigned to the intervention, and 18 patients will be assigned to the control group. The treatment groups will be gender homogeneous. Feasibility as the primary outcome will be analysed in terms of the demand, acceptability, and practicality. Secondary study outcomes will be measured using validated self-rating-scales and physical examinations.

DISCUSSION: To the best of our knowledge, this study is the first to investigate the feasibility of combined psychotherapy and physiotherapy for patients with CPPS. In addition to testing feasibility, the results can be used for the preliminary estimation of therapeutic effects. The results from this study will be used to generate an enhanced therapeutic approach, which might be subject to further testing in a larger study.

TRIAL REGISTRATION: German Clinical Trials Register, DRKS00009976 . Registered on 15 March 2016. ISRCTN, ISRCTN43221600 . Registered on 10 May 2016.