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Graded Exposure Therapy in Chronic Pelvic Pain

Sponsor
Universidad de Granada (Other)
Overall Status
Unknown status
CT.gov ID
NCT03590236
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
11.7
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Graded exposure therapy
  • Other: Physiotherapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Graded Exposure Therapy in Women With Chronic Pelvic Pain
Actual Study Start Date :
Aug 20, 2017
Actual Primary Completion Date :
Feb 12, 2018
Anticipated Study Completion Date :
Aug 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Graded exposure therapy

Patients in this group received graded exposure therapy added to physiotherapy

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.
Other Names:
  • Exposure therapy

    		•
    Active Comparator: Physiotherapy

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

    Other: 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.
    No Intervention: Control group

    Waiting list patients

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. Activity performance [Baseline, 6 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Physical Therapy Granada Spain 18071

    Sponsors and Collaborators

    • Universidad de Granada

    Investigators

    • Principal Investigator: Marie CArmen Valenza, PhD, Universidad de Granada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marie Carmen Valenza, Principal investigator, Universidad de Granada
    ClinicalTrials.gov Identifier:
    NCT03590236
    Other Study ID Numbers:
    • DF0069UG
    First Posted:
    Jul 18, 2018
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marie Carmen Valenza, Principal investigator, Universidad de Granada
    women
    chronic pelvic pain
    fear avoidance
    Additional relevant MeSH terms:
    Pelvic Pain

    Study Results

    No Results Posted as of Jul 18, 2018