Pain in Women With Chronic Pelvic Pain
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Global posture reeducation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pelvic pain, women, pain, posture.
Eligibility 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
Sites / Locations
- Department of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
Adult women aged over 18 years old without chronic pain. will receive no intervention.
Outcomes
Primary Outcome Measures
Change in postural control
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
Nervous assessment
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
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.
Balance under dual task conditions
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.
Trigger points evaluation
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.
Self perceived health status
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.
Full Information
NCT ID
NCT01994343
First Posted
November 19, 2013
Last Updated
July 20, 2018
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT01994343
Brief Title
Pain in Women With Chronic Pelvic Pain
Official Title
Musculoskeletal Disturbances in Women With Chronic Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pelvic pain, women, pain, posture.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Adult women aged over 18 years old without chronic pain. will receive no intervention.
Intervention Type
Other
Intervention Name(s)
Global posture reeducation
Other Intervention Name(s)
Evaluation
Intervention Description
An assessment of the women is performed using global posture reeducation.
Primary Outcome Measure Information:
Title
Change in postural control
Description
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.
Time Frame
Change from baseline postural control at 8 weeks
Secondary Outcome Measure Information:
Title
Nervous assessment
Description
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.
Time Frame
baseline
Title
Spinal assessment
Description
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.
Time Frame
baseline
Title
Balance under dual task conditions
Description
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.
Time Frame
Baseline, 8 weeks
Title
Trigger points evaluation
Description
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.
Time Frame
baseline
Title
Self perceived health status
Description
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.
Time Frame
Baseline, 8 weeks.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32325162
Citation
Rodriguez-Torres J, Lopez-Lopez L, Cabrera-Martos I, Prados-Roman 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.
Results Reference
derived
PubMed Identifier
29025041
Citation
Fuentes-Marquez P, Valenza MC, Cabrera-Martos I, Rios-Sanchez A, Ocon-Hernandez 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.
Results Reference
derived
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Pain in Women With Chronic Pelvic Pain
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