FibromyalgiaFMNCT01823796
Risk of Falls in Patients With Fibromyalgia
An observational study of Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Fibromyalgia women group and Healthy women
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with fibromyalgia. Fibromyalgia is a chronic condition characterised by chronic pain, fatigue, sleep disorders and psychological disturbances.
Who may be able to join
- Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
- Women who can complete the assessment battery of tests and tasks.
Who cannot join
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Gait serious disturbances.
- Concomitant neurological conditions
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Fibromyalgia women group, Healthy women
- Keywords
- Fibromyalgia, balance, falls
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia women groupOther
Also called Fibromyalgia
Assessment of this group at baseline in order to be compared with a control group.
Healthy womenOther
Also called Control group
These women are assessed in order to be compared with fibromyalgia women group.
| Study group | Role | What they receive |
|---|---|---|
| Healthy women. | 35 healthy women. Control group. Receives: Other: Healthy women | |
| Fibromyalgia women group | 35 women with fibromyalgia were measured at baseline of the observational study. Receives: Other: Fibromyalgia women group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: baseline
Tinetti Test
This test evaluated 13 tasks and permit the assessment of the static and dynamic balance.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823796
- Sponsor's protocol ID
- DF0041G
- Acronym
- FM
- Status last verified
- Dec 2014
- First submitted
- 29 Mar 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Balance and Risk of Falls in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01823796
- Acronym / sponsor ID
- FM / DF0041G
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, balance, falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy women. | – | Other: Healthy women35 healthy women. Control group. |
| Fibromyalgia women group | – | Other: Fibromyalgia women group35 women with fibromyalgia were measured at baseline of the observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with fibromyalgia. Fibromyalgia is a chronic condition characterised by chronic pain, fatigue, sleep disorders and psychological disturbances.
Key inclusion criteria (2 listed)
- Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
- Women who can complete the assessment battery of tests and tasks.
Key exclusion criteria (5 listed)
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Gait serious disturbances.
- Concomitant neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibromyalgia women groupAlso: FibromyalgiaAssessment of this group at baseline in order to be compared with a control group. | Other | Fibromyalgia women group |
| Healthy womenAlso: Control groupThese women are assessed in order to be compared with fibromyalgia women group. | Other | Healthy women. |
Primary outcome
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.
3 secondary outcomes
Functional reach test
Time frame: baseline
Single leg stance
Time frame: baseline
Tinetti Test
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up & Go (TUG) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.