Risk of Falls in Patients With Fibromyalgia

NCT01823796 | Completed DMC

• 1 other identifier: DF0041G
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; balance; falls

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional reach test

  baseline

• Single leg stance

  baseline

• Tinetti Test

  baseline

Other Outcomes (1)

• Barthel Index

  baseline

Study Arms (2)

Healthy women.

35 healthy women. Control group.

Other: Healthy women

Fibromyalgia women group

35 women with fibromyalgia were measured at baseline of the observational study.

Other: Fibromyalgia women group

Interventions

Fibromyalgia women group OTHER

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

Also known as: Fibromyalgia

Fibromyalgia women group

Healthy women OTHER

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

Also known as: Control group

Healthy women.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
• Women who can complete the assessment battery of tests and tasks.

You may not qualify if:

• Auditive and visual disturbances.
• Cognitive problems.
• Psychiatric pathology.
• Gait serious disturbances.
• Concomitant neurological conditions

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marie Carmen Valenza, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

ES (1)