Graded Exposure Therapy in Chronic Pelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Graded Exposure Therapy in Women With Chronic Pelvic Pain

Conditions
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Chronic Pelvic Pain

Intervention / Treatment
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* Other: Graded exposure therapy
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graded exposure therapy<br>Patients in this group received graded exposure therapy added to physiotherapy | Other: Graded exposure therapy<br>* Patients included in this group received graded exposure therapy consisting on counselling, a graded activity through postural exercises and individual training focused on 5 activities selected by the patients. The treatment will include 5 sessions added to the 12 sessions of physiotherapy.<br>* Other names: Exposure therapy;|
| Active Comparator: Physiotherapy<br>Patients included in this group received the standard treatment based on a physiotherapy approach. | Other: Physiotherapy<br>* Physiotherapy intervention will include soft tissue mobilizations and myofascial release combined with deep-pressure massage to decrease trigger point-related pain and tension. In addition joint mobilization and muscle energy techniques will be included.<br>|
| No Intervention: Control group<br>Waiting list patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear-avoidance behaviors | 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. | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by the Brief Pain Inventory | 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. | Baseline, 6 weeks | 
| Disability | 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. | Baseline, 6 weeks | 
| Activity performance | The perceived quality of performance will be assessed using the Canadian Ocuppational Performance Measure | Baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, chronic pelvic pain, fear avoidance