Graded Exposure Therapy in Chronic Pelvic Pain

NCT ID: NCT03590236

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2018-08-10

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.

Conditions

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Chronic Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Graded exposure therapy

Patients in this group received graded exposure therapy added to physiotherapy

Group Type EXPERIMENTAL

Graded exposure therapy

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

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.

Control group

Waiting list patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Exposure therapy

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie CArmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Department of Physical Therapy

Granada, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 30312595 (View on PubMed)

Other Identifiers

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DF0069UG

Identifier Type: -

Identifier Source: org_study_id

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