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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02527551 |
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Date of registration:
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16/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study
FEM |
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Scientific title:
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Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02527551 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Stéphane SWEERTVAEGHER, Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU of the Nice |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women aged 18 to 65 years
- Fibromyalgia defined according to ACR criteria
- Widespread pain index (WPI) = 7 and Symptom Severity (SS) scale score = 5 or WPI
between 3 and 6 and SS scale score = 9;
- Presence of symptoms at the same intensity for at least 3 months;
- Available to participate in the proposed sessions six weeks
- Drug Therapy Stable fibromyalgia for one month without amendment in the next 6 months,
excluding analgesics
- Having signed an informed consent
- Affiliated to a health insurance plan
Exclusion criteria
- Vulnerable people: pregnant women, and breastfeeding women (a urine pregnancy test
will be performed), minors, adults under guardianship, deprived of freedom, those
hospitalized without consent, hospitalized in a health and social facility for other
purposes as research, people unable to consent
- Chronic Inflammatory joint disease associated
- Other non-pharmacological treatments (acupuncture, cognitive-behavioral therapy etc
...)
- Impairments severe visceral: heart, kidney, liver in the previous year
- Individualized psychiatric pathology
- Current Infectious diseases
- Skin lesions contra-indicating massage
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
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Intervention(s)
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Other: Massage
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Primary Outcome(s)
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Effectiveness measured by QIF (Questionnary Impact Fibromyalgia) score
[Time Frame: At the end of 6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.]
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Secondary Outcome(s)
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Effectiveness on fatigue measured by items 4 to 10 of QIF score
[Time Frame: 3 and 6 months]
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Effectiveness on stiffness measured by items 4 to 10 of QIF score
[Time Frame: 3 and 6 months]
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Effectiveness on depression measured by items 4 to 10 of QIF score
[Time Frame: 3 and 6 months]
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Effectiveness on anxiety measured by items 4 to 10 of QIF score
[Time Frame: 3 and 6 months]
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Effectiveness on pain measured by items 4 to 10 of QIF score
[Time Frame: 3 and 6 months]
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Secondary ID(s)
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15-AOI-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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