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Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study (FEM)

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ClinicalTrials.gov Identifier: NCT02527551
Recruitment Status : Unknown
Verified May 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : August 19, 2015
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown etiology, characterized by generalized body pain, hyperalgesia and other functional and emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might be severe by its physical and psychological consequences. The etiology of FMS remains unknown but recent studies suggest a disorder of central pain modulation, neurotransmitters, sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues. Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been reported, inducing muscle weakness and local biochemical changes that participate to pain hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are included in chronic pain management recommendations.

Massages are recognized as haptic when the hands of the practitioner move on the skin of the patient; haptic massage is superficial if the pressure applied on the skin is similar to the weight of the hand and it's a deep haptic massage when the pressure applied is over the weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are largely used for athlete to improve muscle recovery and treat tendinitis. All massages evaluate in FMS are superficial haptic massage; they are recognized as efficient on pain, anxiety and depression if they are performed at least on 5 weeks but these effects are transient et remain to be optimized. The efficacy of deep haptic massage has not been evaluated in pathological conditions. The investigators hypothesize that, in FMS patients, deep intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber fibers A lemniscal conveyed by the way that bypass chronic pain information carried by the C fibers of the extra-lemniscal pathway: this is the "Gate Control" theory for inhibiting pain information.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Massage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study
Study Start Date : November 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Haptic massage
6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
Other: Massage
6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.




Primary Outcome Measures :
  1. 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. ]

    To evaluate the effectiveness of the Massage Haptic in 20 women with FMS (defined according to the criteria of the American College of Rheumatology and active disease defined by a Widespread Pain Index (WPI)vscore ≥ 7 and a symptom severity score (SS) ≥ 5 or WPI between 3 and 6 and SS score ≥ 9), recruited in the clinics of the Rheumatology Department of Nice, after 6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.

    Primary endpoint: overall score of impact questionnaire fibromyalgia (QIF). Indeed, in the fibromyalgia studies QIF is used as a criterion for evaluating the effectiveness of drug treatments like non-drug treatments.



Secondary Outcome Measures :
  1. Effectiveness on pain measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ]

    To assess the continuing effects at 3 and 6 months and the impact on pain The effectiveness of haptic massage will be evaluated in the same manner as the main objective.

    The effectiveness of haptic massage on pain will be evaluated through the individual analysis of the items 4 to 10 of QIF score. These items are listed by EVA.


  2. Effectiveness on fatigue measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ]

    To assess the continuing effects at 3 and 6 months and the impact on fatigue The effectiveness of haptic massage will be evaluated in the same manner as the main objective.

    The effectiveness of haptic massage on fatigue will be evaluated through the individual analysis of the items 4 to 10 of QIF score. These items are listed by EVA.


  3. Effectiveness on anxiety measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ]

    To assess the continuing effects at 3 and 6 months and the impact on anxiety The effectiveness of haptic massage will be evaluated in the same manner as the main objective.

    The effectiveness of haptic massage on anxiety will be evaluated through the individual analysis of the items 4 to 10 of QIF score. These items are listed by EVA.


  4. Effectiveness on stiffness measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ]

    To assess the continuing effects at 3 and 6 months and the impact on stiffness The effectiveness of haptic massage will be evaluated in the same manner as the main objective.

    The effectiveness of haptic massage on stiffness will be evaluated through the individual analysis of the items 4 to 10 of QIF score. These items are listed by EVA.


  5. Effectiveness on depression measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ]

    To assess the continuing effects at 3 and 6 months and the impact on depression The effectiveness of haptic massage will be evaluated in the same manner as the main objective.

    The effectiveness of haptic massage on depression will be evaluated through the individual analysis of the items 4 to 10 of QIF score. These items are listed by EVA.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527551


Contacts
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Contact: Veronique BREUIL, MD, PhD +33 4 92 03 55 12 breuil.v@chu-nice.fr
Contact: Arnaud CHOPLIN +33 4 92 03 64 53 Arnaud.choplin@unice.fr

Locations
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France
BREUIL Recruiting
Nice, France, 06000
Contact: VERONIQUE BREUIL, MD    4 92 03 55 12 ext +33      
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Study Director: Stéphane SWEERTVAEGHER, Director CHU of the Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02527551     History of Changes
Other Study ID Numbers: 15-AOI-06
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases