Pain in Women With Chronic Pelvic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01994343
First received: November 19, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Chronic Pelvic Pain.
Other: Assessment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Musculoskeletal Disturbances in Women With Chronic Pelvic Pain

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Pressure pain measure [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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:
  • Nervous assessment [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

    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.


  • Spinal assessment [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.

  • Posture assessment [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.

  • Trigger points evaluation [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic pelvic pain
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
Adult women aged over 18 years old without chronic pain.
Other: Assessment
An assessment of the women is performed.
Other Name: Evaluation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994343

Contacts
Contact: Marie Carmen Valenza, PhD 958242360 cvalenza@ugr.es

Locations
Spain
Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958242360    cvalenza@ugr.es   
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01994343     History of Changes
Other Study ID Numbers: DF0044UG
Study First Received: November 19, 2013
Last Updated: May 19, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014