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Risk of Falls in Patients With Fibromyalgia

NCT ID: NCT01823796

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%.

The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.

Detailed Description

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Falls and fall-related injuries are a common health problem. A fall is often a result of intrinsic physiological ageing and underlying chronic disease interacting with the external and challenging environment. Disturbances in physical function, muscle strength, range of motion, poor balance, affectation in sensory system, a loss of proprioception, alteration concerning visual and vestibular aspects, dizziness, decreased endurance and cognitive and mobility impairment are the most common risk factors for falls. Postural control in a dual task setting is especially relevant to daily life situations. Attending to that, we propose an assessment based on these parameters in women with fibromyalgia.

Conditions

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Fibromyalgia

Keywords

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Fibromyalgia balance falls

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy women.

35 healthy women. Control group.

Healthy women

Intervention Type OTHER

These women are assessed in order to be compared with fibromyalgia women group.

Fibromyalgia women group

35 women with fibromyalgia were measured at baseline of the observational study.

Fibromyalgia women group

Intervention Type OTHER

Assessment of this group at baseline in order to be compared with a control group.

Interventions

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Fibromyalgia women group

Assessment of this group at baseline in order to be compared with a control group.

Intervention Type OTHER

Healthy women

These women are assessed in order to be compared with fibromyalgia women group.

Intervention Type OTHER

Other Intervention Names

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Fibromyalgia Control group

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests and tasks.

Exclusion Criteria

* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Gait serious disturbances.
* Concomitant neurological conditions
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Carmen Valenza, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Faculty of Health Sciences. University of Granada.

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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DF0041G

Identifier Type: -

Identifier Source: org_study_id