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Risk of Falls in Patients With Fibromyalgia

Assessment of Balance and Risk of Falls in Women With Fibromyalgia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01823796
Acronym
FM
Enrollment
60
Registered
2013-04-04
Start date
2013-03-31
Completion date
2013-08-31
Last updated
2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, balance, falls

Brief summary

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

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.

Interventions

OTHERFibromyalgia women group

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

OTHERHealthy women

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

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Timed up & Go (TUG)baselineThis test timed in seconds measure the time taken by the participant to stand up from an arm chair, walk 3 metres at normal pace, turn around, walk back and sit down. They start to the order of Go! A stopwatch was used to measure the time. The TUG is a frequently used test to assess mobility and fall risks in older adults and is recommended by American Geriatrics Society (2011) as a screening tool. The timed up and go combined with a cognitive task was also measured.

Secondary

MeasureTime frameDescription
Functional reach testbaselineIt is a quick and simple test. It score the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position. The subject is asked to reach forward as far as possible without taking a step or touching the wall. It measure the ability of maintain balance during a functional task. It has been shown to be predictive of falls. It was tested with a tape measure on the wall using the head of the metacarpal of the third finger as the reference point.
Single leg stancebaselineThis is a frequently clinical tool used to assess balance and postural steadiness. In the start position the person stand erect with arm folded across chest and the head facing straight ahead; shoes off. The subject is asked to lift one leg off the floor, based on preference of subject and keep the leg raised as long as possible without touching the other leg. Timer is stopped whether the subject's raised foot either touches the floor, makes contact with other leg or moves the stance foot to create a new base of support,if the arms move out of the test position or when a maximum balance time of 30s take place. The time was measured with a stopwatch.
Tinetti TestbaselineThis test evaluated 13 tasks and permit the assessment of the static and dynamic balance.

Other

MeasureTime frameDescription
Barthel IndexbaselineClinical application tool of 10 items that can be administered in 2-5 minutes by a member of the medical staff or self-administered in about 10 minutes. It measure the ability to achieve certain activities without help

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026