Pain in Women With Chronic Pelvic Pain

July 20, 2018 updated by: Marie Carmen Valenza, Universidad de Granada

Musculoskeletal Disturbances in Women With Chronic Pelvic Pain

Chronic pelvis pain is very common between adult women. Significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. The purpose of this study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at least 6 months. This pain interfere with habitual activities and requires clinical or surgical treatment. It is a complex interaction between the gastrointestinal, urinary, gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14 to 24% among women of reproductive age. It is very important a multidimensional approach in order to stablish a more specific profile.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women.
  • Clinical diagnosis of chronic pelvic pain.
  • More than eighteen years.
  • Non-menstrual or noncyclic pelvic pain.
  • Duration of pain of at least 6 months.

Exclusion Criteria:

  • Duration of pain less than 6 months.
  • Women who were pregnant in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Adult women aged over 18 years old with pain during more than six months are included in the study. These patients will receive a global posture reeducation.
Other: Global posture reeducation
An assessment of the women is performed using global posture reeducation.
Other Names:
  • Evaluation
No Intervention: Control group
Adult women aged over 18 years old without chronic pain. will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in postural control
Time Frame: Change from baseline postural control at 8 weeks
Postural control will be assessed using the Mini-BESTest, a 14-item test that focuses on dynamic balance, specifically anticipatory transitions (six items), reactive postural control (six items), sensory orientation (six items), and dynamic gait (10 items). Each item is scored from 0 to 2; a score of 0 indicates that a person is unable to perform the task, whereas a score of 2 is normal. The best score is the maximum amount of points, being 28.
Change from baseline postural control at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nervous assessment
Time Frame: baseline

The nervous assessment is measured with neurodynamic tests. This is used to test upper and lower extremities. It moves most of the nerves between the neck and legs, including the spinal nerves and lower limbs nerves.

The patient is placed in supine position. It is measured with a goniometer.
baseline
Spinal assessment
Time Frame: baseline
The spinal assessment is going to be performed using the Spinal Mouse. Spinal Mouse is a device that, combined with a computer program, assesses the curvatures of the vertebral column without applying harmful radiation. Spinal Mouse checks: spine alignment, measuring segmental and global angles in the sagittal and frontal planes; posture and spinal mobility; spine functions and performance.
baseline
Balance under dual task conditions
Time Frame: Baseline, 8 weeks
Women were asked to complete three trials of the TUG under three conditions: performance of the TUG alone, performance of the TUG with the addition of a cognitive task (TUG cognitive), and performance of the TUG with the addition of an upper-extremity motor task (TUG manual). Women were given verbal instructions to stand up from a chair, walk 3 m as quickly and as safely as possible, cross a line marked on the floor, turn around, walk back, and sit down. In the TUG cognitive, women were asked to complete the test while counting backward by threes from a randomly selected number between 20 and 100. In the TUG manual, women were asked to complete the test while carrying a full cup of water.
Baseline, 8 weeks
Trigger points evaluation
Time Frame: baseline
Trigger points are discrete, focal, hyperirritable spots located in a taut band of skeletal muscle. A pressure at a trigger point is performed in order to evoke pain at the point as well as referred pain in myofascial or visceral structures. The trigger points located in the gluteal and adductors muscles are going to be assessed.
baseline
Self perceived health status
Time Frame: Baseline, 8 weeks.
Health status was assessed by the Euroqol-5dimensions (EQ-5D). It is divided into 2 sections. The first section contains 5 questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each question, problems within the domain are evaluated on a 3-level basis. Responders can choose between "no problems", "some problems" or "extreme problems". The second part is a visual analogue scale (VAS) score, which records the responder's self-evaluated health status, where 0 is worst imaginable health and 100 is best imaginable health.
Baseline, 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DF0044UG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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