Risk of Falls in Fibromyalgia (FM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01823796
First received: March 29, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Fibromyalgia women group
Other: Healthy women

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Balance and Risk of Falls in Women With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Timed up & Go (TUG) [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

    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:
  • Functional reach test [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.


Other Outcome Measures:
  • Barthel Index [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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


Enrollment: 60
Study Start Date: March 2013
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy women.
35 healthy women. Control group.
Other: Healthy women
These women are assessed in order to be compared with fibromyalgia women group.
Other Name: Control group
Fibromyalgia women group
35 women with fibromyalgia were measured at baseline of the observational study.
Other: Fibromyalgia women group
Assessment of this group at baseline in order to be compared with a control group.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women with fibromyalgia. Fibromyalgia is a chronic condition characterised by chronic pain, fatigue, sleep disorders and psychological disturbances.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823796

Locations
Spain
Faculty of Health Sciences. University of Granada.
Granada., Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01823796     History of Changes
Other Study ID Numbers: DF0041G
Study First Received: March 29, 2013
Last Updated: November 13, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
Fibromyalgia
balance
falls

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014