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Trial record 10 of 97 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT02527551
First received: July 16, 2015
Last updated: May 3, 2016
Last verified: May 2016
  Purpose

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 Intervention
Fibromyalgia
Other: Massage

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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:
  • Effectiveness on pain measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

    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.


  • Effectiveness on fatigue measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

    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.


  • Effectiveness on anxiety measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

    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.


  • Effectiveness on stiffness measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

    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.


  • Effectiveness on depression measured by items 4 to 10 of QIF score [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 20
Study Start Date: November 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02527551

Contacts
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
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
Study Director: Stéphane SWEERTVAEGHER, Director CHU of the Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02527551     History of Changes
Other Study ID Numbers: 15-AOI-06 
Study First Received: July 16, 2015
Last Updated: May 3, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on December 02, 2016