Skip to main content
OpenTrials
Completed

NCT Number: NCT01823796

Risk of Falls in Patients With Fibromyalgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Health Sciences. University of Granada.

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibromyalgia women group

Other

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

Other names: Fibromyalgia

Healthy women

Other

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

Other names: Control group

Primary outcomes

  1. Timed up & Go (TUG)

    Time frame: 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 outcomes

  1. Functional reach test

    Time frame: 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.

  2. Single leg stance

    Time frame: 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.

  3. Tinetti Test

    Time frame: baseline

    This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.

Other outcomes

  1. Barthel Index

    Time frame: baseline

    Clinical 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Assessment of Balance and Risk of Falls in Women With Fibromyalgia

Acronym: FM

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.