FibromyalgiaNCT02144116
Dance-movement Therapy Programme in Fibromyalgia.
A study testing Dance-movement therapy in people with 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 generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dance-movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jan 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed of Fibromyalgia attending to the Fibromyalgia Association of Granada.
- Women who can complete the assessment battery of tests at the beginning and at the end of the study
Who cannot join
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Traumatic pathology of lower limbs.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, Granada, 18071
Marie Carmen Valenza, PhD, 958242360, cvalenza@ugr.es
Marie Carmen Valenza, PhD
About this study
Official title: Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.
Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia is associated with balance problems and increased fall frequency. The objective of this study was to examine the effects of an 8 weeks dance-movement therapy programme on balance, strength, flexibility and quality of life in patients with fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic condition associated with balance problems and pain. It has been previously described that fibromyalgia may affect peripheral and/or central mechanisms of postural control. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance.
Patients with fibromyalgia have also muscle weakness. Muscle strength depends on both the cross-sectional area of the muscle and the neural activity. Range of movement and quality of life have also been reported to be affected.
- Conditions
- Fibromyalgia
- Being tested
- Dance-movement therapy, Control group
- Keywords
- dance-movement therapy, balance, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance-movement therapyOther
Also called intervention, dance therapy, occupational therapy
The dance-movement was practised in groups. Dance-movement therapy derived from dance education. The goals of dance-movement therapy included assessing patient needs, communicating emotions, improving self-control, organizing thoughts and actions, developing interpersonal skills, integrating physical and emotional selves, promoting body awareness, and supporting healing.
Control groupOther
Also called Control, Education
Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with fibromyalgia included in a dance-movement therapy programme Receives: Other: Dance-movement therapy |
| Control group | Active comparator | Patients with fibromyalgia who receive a standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in balance
Balance is going to be assessed with the Mini BalanceEvaluation System Test. This test assesses dynamic balance, with four subscales:anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait.
The Mini BESTest is a 14 item test scored on a 3 level ordinal scale. For the Mini BESTest, the original BESTest 4 level (0 - 3) scoring was revised to 3 levels (0 - 2) due to redundancy. Total score = 28 points per test directions. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, many studies specify use of both left and right data, thus calculating data based on 32 (vs 28) points
Measured: Baseline, 8 weeks
Secondary outcomes (3)
Changes in quadriceps strength
Changes from baseline to postintervention on quadriceps strength. This will be measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side. The maximum value achieved from all six attempts was used in analyses. Kg/cm2.
Measured: Baseline, 8 weeks
Changes in quality of life
Quality of life associated with health. This is going to be measure with the EuroQol-5 questionnaire.
Measured: Baseline, 8 weeks
Changes in flexibility of lower limbs
Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
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
- NCT02144116
- Sponsor's protocol ID
- DF0052UG
- Status last verified
- Oct 2016
- First submitted
- 19 May 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT02144116
- Acronym / sponsor ID
- DF0052UG
- Conditions
- Fibromyalgia
- Keywords
- dance-movement therapy, balance, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 May 2014 (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 generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia is associated with balance problems and increased fall frequency. The objective of this study was to examine the effects of an 8 weeks dance-movement therapy programme on balance, strength, flexibility and quality of life in patients with fibromyalgia.
Detailed description
Fibromyalgia is a chronic condition associated with balance problems and pain. It has been previously described that fibromyalgia may affect peripheral and/or central mechanisms of postural control. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance.
Patients with fibromyalgia have also muscle weakness. Muscle strength depends on both the cross-sectional area of the muscle and the neural activity. Range of movement and quality of life have also been reported to be affected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Dance-movement therapyPatients with fibromyalgia included in a dance-movement therapy programme |
| Control group | Active comparator | Other: Control groupPatients with fibromyalgia who receive a standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed of Fibromyalgia attending to the Fibromyalgia Association of Granada.
- Women who can complete the assessment battery of tests at the beginning and at the end of the study
Key exclusion criteria (4 listed)
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Traumatic pathology of lower limbs.
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 |
|---|---|---|
| Dance-movement therapyAlso: intervention, dance therapy, occupational therapyThe dance-movement was practised in groups. Dance-movement therapy derived from dance education. The goals of dance-movement therapy included assessing patient needs, communicating emotions, improving self-control, organizing thoughts and actions, developing interpersonal skills, integrating physical and emotional selves, promoting body awareness, and supporting healing. | Other | Experimental group |
| Control groupAlso: Control, EducationStandardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia. | Other | Control group |
Primary outcome
Changes in balance
Time frame: Baseline, 8 weeks
Balance is going to be assessed with the Mini BalanceEvaluation System Test. This test assesses dynamic balance, with four subscales:anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The Mini BESTest is a 14 item test scored on a 3 level ordinal scale. For the Mini BESTest, the original BESTest 4 level (0 - 3) scoring was revised to 3 levels (0 - 2) due to redundancy. Total score = 28 points per test directions. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, many studies specify use of both left and right data, thus calculating data based on 32 (vs 28) points
3 secondary outcomes
Changes in quadriceps strength
Time frame: Baseline, 8 weeks
Changes in quality of life
Time frame: Baseline, 8 weeks
Changes in flexibility of lower limbs
Time frame: Baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
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Daily Cognitive Failures and Medication Adherence in Fibromyalgia
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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?
A study testing Dance-movement therapy in people with 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 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in balance (time frame: Baseline, 8 weeks). 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 28 Oct 2016.