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Graded Exposure Therapy in Chronic Pelvic Pain

Primary Purpose

Chronic Pelvic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Graded exposure therapy
Physiotherapy
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring women, chronic pelvic pain, fear avoidance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Graded exposure therapy

Physiotherapy

Control group

Arm Description

Patients in this group received graded exposure therapy added to physiotherapy

Patients included in this group received the standard treatment based on a physiotherapy approach.

Waiting list patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Activity performance
The perceived quality of performance will be assessed using the Canadian Ocuppational Performance Measure

Full Information

First Posted
September 7, 2017
Last Updated
July 17, 2018
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03590236
Brief Title
Graded Exposure Therapy in Chronic Pelvic Pain
Official Title
Graded Exposure Therapy in Women With Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
August 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain
Keywords
women, chronic pelvic pain, fear avoidance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Graded exposure therapy
Arm Type
Experimental
Arm Description
Patients in this group received graded exposure therapy added to physiotherapy
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Patients included in this group received the standard treatment based on a physiotherapy approach.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waiting list patients
Intervention Type
Other
Intervention Name(s)
Graded exposure therapy
Other Intervention Name(s)
Exposure therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fear-avoidance behaviors
Description
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.
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Pain assessed by the Brief Pain Inventory
Description
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.
Time Frame
Baseline, 6 weeks
Title
Disability
Description
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.
Time Frame
Baseline, 6 weeks
Title
Activity performance
Description
The perceived quality of performance will be assessed using the Canadian Ocuppational Performance Measure
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie CArmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30312595
Citation
Ariza-Mateos MJ, Cabrera-Martos I, Ortiz-Rubio A, Torres-Sanchez I, Rodriguez-Torres J, Valenza MC. Effects of a Patient-Centered Graded Exposure Intervention Added to Manual Therapy for Women With Chronic Pelvic Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jan;100(1):9-16. doi: 10.1016/j.apmr.2018.08.188. Epub 2018 Oct 9.
Results Reference
derived

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Graded Exposure Therapy in Chronic Pelvic Pain

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