Pain in Women With Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01994343
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Pain Other: Assessment

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 : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Musculoskeletal Disturbances in Women With Chronic Pelvic Pain
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Chronic pelvic pain- Assessment
Adult women aged over 18 years old with pain during more than six months are included in the study.
Other: Assessment
An assessment of the women is performed.
Other Name: Evaluation

Control group- Assessment
Adult women aged over 18 years old without chronic pain.
Other: Assessment
An assessment of the women is performed.
Other Name: Evaluation

Primary Outcome Measures :
  1. Pressure pain measure [ Time Frame: baseline ]
    Pain pressure threshold at baseline. This is going to be measured in four points (anterior tibialis, between the second and third metacarpophalangeal joint, between the fifth and the sixth vertical vertebrae and an abdominal point). All assessments were made by the same investigator. All the subjects were trained to familiarize the subjects with the pressure algometry procedure before the measures in an anatomical site different from the chosen sites for this study.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Posture assessment [ Time Frame: baseline ]
    The posture is going to be assessed using the Mensendieck test. It is a standardized test applied to evaluate posture, movement, gait, sitting posture, and respiration of patients with psychosomatic disorders, based on observation and analysis of motor function.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult women with more than eighteen years with non-menstrual or noncyclic pelvic pain with duration of at least 6 months, sufficiently intense to interfere with habitual activities.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01994343

Department of Physical Therapy
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada Identifier: NCT01994343     History of Changes
Other Study ID Numbers: DF0044UG
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
Chronic pelvic pain, women, pain, posture.

Additional relevant MeSH terms:
Chronic Pain
Pelvic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms