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Risk of Falls in Patients With Fibromyalgia (FM)

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ClinicalTrials.gov Identifier: NCT01823796
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, 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.


Condition or disease Intervention/treatment
Fibromyalgia Other: Fibromyalgia women group Other: Healthy women

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 Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Balance and Risk of Falls in Women With Fibromyalgia
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Fibromyalgia
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823796


Locations
Spain
Faculty of Health Sciences. University of Granada.
Granada., Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01823796     History of Changes
Other Study ID Numbers: DF0041G
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Marie Carmen Valenza, 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