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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Massage
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • BREUIL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Haptic massage

Arm Description

6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.

Outcomes

Primary Outcome Measures

Effectiveness measured by QIF (Questionnary Impact Fibromyalgia) score
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
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
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
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
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
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.

Full Information

First Posted
July 16, 2015
Last Updated
November 17, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02527551
Brief Title
Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study
Acronym
FEM
Official Title
Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haptic massage
Arm Type
Other
Arm Description
6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
Primary Outcome Measure Information:
Title
Effectiveness measured by QIF (Questionnary Impact Fibromyalgia) score
Description
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.
Time Frame
At the end of 6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
Secondary Outcome Measure Information:
Title
Effectiveness on pain measured by items 4 to 10 of QIF score
Description
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.
Time Frame
3 and 6 months
Title
Effectiveness on fatigue measured by items 4 to 10 of QIF score
Description
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.
Time Frame
3 and 6 months
Title
Effectiveness on anxiety measured by items 4 to 10 of QIF score
Description
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.
Time Frame
3 and 6 months
Title
Effectiveness on stiffness measured by items 4 to 10 of QIF score
Description
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.
Time Frame
3 and 6 months
Title
Effectiveness on depression measured by items 4 to 10 of QIF score
Description
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.
Time Frame
3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane SWEERTVAEGHER, Director
Organizational Affiliation
CHU of the Nice
Official's Role
Study Director
Facility Information:
Facility Name
BREUIL
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study

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