Graded Exposure Therapy in Chronic Pelvic Pain

Chronic Pelvic Pain Clinical Trial

Official title:

Graded Exposure Therapy in Women With Chronic Pelvic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03590236
• Other study ID #: DF0069UG
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: July 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 10, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain

Intervention

Other:
• Graded exposure therapy
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.
• Physiotherapy
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.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Activity performance	The perceived quality of performance will be assessed using the Canadian Ocuppational Performance Measure	Baseline, 6 weeks