NCT01994343

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

November 19, 2013

Last Update Submit

July 20, 2018

Conditions

Chronic Pain

Keywords

Chronic pelvic pain, women, pain, posture.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline postural control at 8 weeks

Secondary Outcomes (5)

  • Nervous assessment

    baseline

  • Spinal assessment

    baseline

  • Balance under dual task conditions

    Baseline, 8 weeks

  • Trigger points evaluation

    baseline

  • Self perceived health status

    Baseline, 8 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Adult women aged over 18 years old without chronic pain. will receive no intervention.

Interventions

Global posture reeducationOTHER

An assessment of the women is performed using global posture reeducation.

Also known as: Evaluation
Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

Related Publications (2)

  • 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.

    PMID: 32325162DERIVED

  • 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.

    PMID: 29025041DERIVED

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

August 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

ES(1)