Pain in Women With Chronic Pelvic Pain

• ClinicalTrials.gov Identifier: NCT01994343
• Recruitment Status: Unknown
• First Posted: November 25, 2013
• Last Update Posted: July 24, 2018
• Sponsor: Universidad de Granada
• Information provided by (Responsible Party): Marie Carmen Valenza, Universidad de Granada

Study Description

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	Phase
Chronic Pain	Other: Global posture reeducation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Musculoskeletal Disturbances in Women With Chronic Pelvic Pain
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2016
• Estimated Study Completion Date: August 2018

Arms and Interventions

Arm	Intervention/treatment
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 Name: Evaluation
No Intervention: Control group; Adult women aged over 18 years old without chronic pain. will receive no intervention.

Outcome Measures

Primary Outcome Measures :

1. 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.

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. 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.
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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

Spain

Department of Physical Therapy

Granada, Spain, 18071

Sponsors and Collaborators

Universidad de Granada

Investigators

• Principal Investigator: Marie Carmen Valenza, PhD; Universidad de Granada

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rodríguez-Torres J, López-López L, Cabrera-Martos I, Prados-Román E, Granados-Santiago M, Valenza MC. Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Aug;101(8):1304-1312. doi: 10.1016/j.apmr.2020.02.019. Epub 2020 Apr 20.

Fuentes-Márquez P, Valenza MC, Cabrera-Martos I, Ríos-Sánchez A, Ocón-Hernández O. Trigger Points, Pressure Pain Hyperalgesia, and Mechanosensitivity of Neural Tissue in Women with Chronic Pelvic Pain. Pain Med. 2019 Jan 1;20(1):5-13. doi: 10.1093/pm/pnx206.

• Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT01994343
• Other Study ID Numbers: DF0044UG
• First Posted: November 25, 2013
• Last Update Posted: July 24, 2018
• Last Verified: July 2018

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; Pain; Neurologic Manifestations