NCT03590236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

September 7, 2017

Last Update Submit

July 17, 2018

Conditions

Chronic Pelvic Pain

Keywords

womenchronic pelvic painfear avoidance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain assessed by the Brief Pain Inventory

    Baseline, 6 weeks

  • Disability

    Baseline, 6 weeks

  • Activity performance

    Baseline, 6 weeks

Study Arms (3)

Graded exposure therapy

EXPERIMENTAL

Patients in this group received graded exposure therapy added to physiotherapy

Other: Graded exposure therapy

Physiotherapy

ACTIVE COMPARATOR

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

Other: Physiotherapy

Control group

NO INTERVENTION

Waiting list patients

Interventions

Graded exposure therapyOTHER

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.

Also known as: Exposure therapy
Graded exposure therapy
PhysiotherapyOTHER

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.

Physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic pelvic pain
  • Moderate fear of movement

You may not qualify if:

  • Other clinical diagnosis.
  • Men
  • Other pathology such as neurological disease.
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30312595DERIVED

MeSH Terms

Interventions

Implosive TherapyPhysical Therapy Modalities

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsRehabilitation

Study Officials

  • Marie CArmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 7, 2017

First Posted

July 18, 2018

Study Start

August 20, 2017

Primary Completion

February 12, 2018

Study Completion

August 10, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

ES(1)