Risk of Falls in Patients With Fibromyalgia

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Fibromyalgia women group; Other: Healthy women

• Registration Number: NCT01823796
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-04
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibromyalgia women group	Fibromyalgia women group	35 women with fibromyalgia were measured at baseline of the observational study.
Healthy women.	Healthy women	35 healthy women. Control group.

Primary Outcome Measures

Name	Time	Method
Timed up & Go (TUG)	baseline	This 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 Outcome Measures

Name	Time	Method
Functional reach test	baseline	It 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 stance	baseline	This 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 Test	baseline	This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.

Trial Locations

Locations (1)

Faculty of Health Sciences. University of Granada.; 🇪🇸 Granada., Granada, Spain