Graded Exposure Therapy in Chronic Pelvic Pain

Not Applicable

• Conditions: Chronic Pelvic Pain
• Interventions: Other: Graded exposure therapy; Other: Physiotherapy

• Registration Number: NCT03590236
• Lead Sponsor: Universidad de Granada

Brief Summary

Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. The objective of this study was to evaluate the effects of graded exposure therapy in women with chronic pelvic pain.

Detailed Description

Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. This condition lasts at least 6 months, and many times is associated with negative cognitive, emotional, sexual and behavioral consequences.In addition to the high economic cost, CPP is also costly in emotional and psychological suffering. This clinical trial aims to evaluate the effects of a program based on graded exposure therapy in women with chronic pelvic pain.

Study Timeline

• Study Start: 2017-08-20
• Study First Submitted: 2017-09-07
• Primary Completion: 2018-02-12
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18
• Study Completion: 2018-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of chronic pelvic pain
• Moderate fear of movement

Exclusion Criteria

• Other clinical diagnosis.
• Men
• Other pathology such as neurological disease.
• Cognitive impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graded exposure therapy	Graded exposure therapy	Patients in this group received graded exposure therapy added to physiotherapy
Physiotherapy	Physiotherapy	Patients included in this group received the standard treatment based on a physiotherapy approach.

Primary Outcome Measures

Name	Time	Method
Fear-avoidance behaviors	Baseline, 6 weeks	Changes from baseline to the end of the intervention will be assessed with the Fear Avoidance Beliefs Questionnaire (FABQ) using the physical activity subscale. This subscale focus on patients' beliefs about how physical activity affected their pain. The values ranges from 0 to 24 with higher scores indicating higher levels of fear-avoidance beliefs.

Secondary Outcome Measures

Name	Time	Method
Pain assessed by the Brief Pain Inventory	Baseline, 6 weeks	Changes from baseline to the end of the intervention on pain will be assessed using the Brief Pain Inventory. This instrument evaluates the intensity of pain and also the degree to which the pain interferes in activities of daily living. The arithmetic mean ranging from 0 to 10 of the four severity items will be used as measures of pain severity; the arithmetic mean ranging from 0 to 10 of the seven interference items will be used as a measure of pain interference. Higher score represents worse pain.
Disability	Baseline, 6 weeks	Changes from baseline to the end of the intervention will ibe assessed using the Oswestry Disability Index. It includes 10 items that assess how pain affects common daily activities. Scores range from 0 (no disability) to 100 (completely disabled), so higher scores indicate higher disability.
Activity performance	Baseline, 6 weeks	The perceived quality of performance will be assessed using the Canadian Ocuppational Performance Measure

Trial Locations

Locations (1)

Department of Physical Therapy; 🇪🇸 Granada, Spain