Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial

TY - JOUR

T1 - Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial

AU - Brünahl, Christian A

AU - Klotz, Susanne G R

AU - Dybowski, Christoph

AU - Albrecht, Rebecca

AU - Höink, Johanna

AU - Fisch, Margit

AU - Ketels, Gesche

AU - Löwe, Bernd

N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/12/14

Y1 - 2021/12/14

N2 - OBJECTIVE: To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS).DESIGN: Prospective non-randomised controlled pilot study.SETTING: Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS.PARTICIPANTS: A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up.INTERVENTIONS: Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual).MAIN OUTCOME MEASURES: Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied.RESULTS: Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain.CONCLUSIONS: The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed.TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00009976) and ISRCTN (ISRCTN43221600).

AB - OBJECTIVE: To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS).DESIGN: Prospective non-randomised controlled pilot study.SETTING: Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS.PARTICIPANTS: A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up.INTERVENTIONS: Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual).MAIN OUTCOME MEASURES: Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied.RESULTS: Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain.CONCLUSIONS: The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed.TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00009976) and ISRCTN (ISRCTN43221600).

U2 - 10.1136/bmjopen-2021-053421

DO - 10.1136/bmjopen-2021-053421

M3 - SCORING: Journal article

C2 - 34907064

VL - 11

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 12

M1 - e053421

ER -