Risk of Falls in Patients With Fibromyalgia (FM)

Assessment of Balance and Risk of Falls in Women 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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Healthy women; Other: Fibromyalgia women group

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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Spain
  • Granada
    • Granada., Granada, Spain, 18071
      • Faculty of Health Sciences. University of Granada.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Fibromyalgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up & Go (TUG)	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional reach test	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.	baseline
Single leg stance	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.	baseline
Tinetti Test	This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	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	baseline

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: falls; Fibromyalgia; balance
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: DF0041G