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A New Rehabilitation Tool in Fibromyalgia

Primary Purpose

Fibromyalgia, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercises treatment
Perceptive Rehabilitation Treatment
Control group
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Postural exercise, Back pain, Tender points, Fibromyalgia, Perceptive rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
  • Subjects aged between 18 and 60 years
  • visual analog scale (VAS) for pain > 5

Exclusion Criteria:

  • presence of concomitant autoimmune diseases
  • psychiatric disorders
  • other causes of chronic pain
  • other diseases that prevented physical loading
  • severe scoliosis or kyphoscoliosis
  • surgery of the spine
  • vertebral fractures
  • sciatic pain
  • tumors
  • enrolled in another type of physical therapy program
  • myocardial infarction
  • lower extremity arterial disease
  • major neurological problems
  • diabetes
  • gastrointestinal disease
  • chronic respiratory disease
  • kidney disease
  • poor vision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Physical exercises treatment

    Perceptive Rehabilitation Treatment

    Control group

    Arm Description

    The types of exercises included: low-impact to moderate aerobic training (gradually starting from 50% of the Fc max to 70%-80% of Fc max); walking fast in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes) for a total of 20 consecutive minutes; posture exercises for the back and proprioceptive exercises for the trunk in the supine position to improve axial stability, including diaphragmatic breathing.

    Perceptual surfaces is a therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips; usually, over 100 cones are used for each session. Patients were asked to lie down supine on the surface that was formed by the smoothed apex of these cones, creating reaction forces to the patient's weight, generated by the interaction with the cones.

    The control group did brief educational sessions.

    Outcomes

    Primary Outcome Measures

    Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
    It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.

    Secondary Outcome Measures

    Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
    It comprises 3 sections-function, impact, and symptoms-combining to generate an overall score. The first section contains 10 sub items and focuses on the patient's ability to perform daily tasks that involve the large muscles (eg, cooking, cleaning, walking, shopping, homemaking, socializing, and mobility). The next 2 items ask patients to circle the number of days in the past week in which they felt good and the number of days that they missed work. The last 7 items assess the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score on the FIQ is calculated by adding the following 10 items: the physical function score, the number of days feeling good, the number of work days missed, the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The FIQ score ranges from 0 to 100, with 100 indicating the worst possible score due to Fibromylgia.
    Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
    It is a 20-item self-administered questionnaire that determines the difficulty in performing 8 daily activities (dressing and grooming, getting up, eating, walking, hygiene, reaching, ability to grip, and outside activities). For each item, patients are asked to rate the level of difficulty that they have experienced over the previous week in performing these activities on a 4-point scale from 0 (no difficulty) to 3 (unable to perform). The final HAQ score is the average score of the 8 categories, thus ranging from 0 to 3; higher scores reflect greater levels of disability.

    Full Information

    First Posted
    June 6, 2015
    Last Updated
    June 10, 2015
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02472093
    Brief Title
    A New Rehabilitation Tool in Fibromyalgia
    Official Title
    A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia, Pain
    Keywords
    Postural exercise, Back pain, Tender points, Fibromyalgia, Perceptive rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical exercises treatment
    Arm Type
    Active Comparator
    Arm Description
    The types of exercises included: low-impact to moderate aerobic training (gradually starting from 50% of the Fc max to 70%-80% of Fc max); walking fast in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes) for a total of 20 consecutive minutes; posture exercises for the back and proprioceptive exercises for the trunk in the supine position to improve axial stability, including diaphragmatic breathing.
    Arm Title
    Perceptive Rehabilitation Treatment
    Arm Type
    Experimental
    Arm Description
    Perceptual surfaces is a therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips; usually, over 100 cones are used for each session. Patients were asked to lie down supine on the surface that was formed by the smoothed apex of these cones, creating reaction forces to the patient's weight, generated by the interaction with the cones.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group did brief educational sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Physical exercises treatment
    Other Intervention Name(s)
    Rehabilitation Group Exercises
    Intervention Description
    Includes different types of exercises: low-impact to moderate aerobic training; walking fast in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes) for a total of 20 consecutive minutes; posture exercises for the back and proprioceptive exercises for the trunk in the supine position to improve axial stability, including diaphragmatic breathing. The heart rate was monitored through the use of a heart rate monitor, which allowed not to exceed the threshold.
    Intervention Type
    Other
    Intervention Name(s)
    Perceptive Rehabilitation Treatment
    Other Intervention Name(s)
    Perceptual surfaces
    Intervention Description
    therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    The control group did brief educational sessions.
    Primary Outcome Measure Information:
    Title
    Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
    Description
    It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.
    Time Frame
    baseline, 4 weeks, 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
    Description
    It comprises 3 sections-function, impact, and symptoms-combining to generate an overall score. The first section contains 10 sub items and focuses on the patient's ability to perform daily tasks that involve the large muscles (eg, cooking, cleaning, walking, shopping, homemaking, socializing, and mobility). The next 2 items ask patients to circle the number of days in the past week in which they felt good and the number of days that they missed work. The last 7 items assess the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score on the FIQ is calculated by adding the following 10 items: the physical function score, the number of days feeling good, the number of work days missed, the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The FIQ score ranges from 0 to 100, with 100 indicating the worst possible score due to Fibromylgia.
    Time Frame
    baseline, 4 weeks, 12 weeks
    Title
    Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
    Description
    It is a 20-item self-administered questionnaire that determines the difficulty in performing 8 daily activities (dressing and grooming, getting up, eating, walking, hygiene, reaching, ability to grip, and outside activities). For each item, patients are asked to rate the level of difficulty that they have experienced over the previous week in performing these activities on a 4-point scale from 0 (no difficulty) to 3 (unable to perform). The final HAQ score is the average score of the 8 categories, thus ranging from 0 to 3; higher scores reflect greater levels of disability.
    Time Frame
    baseline, 4 weeks, 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010) Subjects aged between 18 and 60 years visual analog scale (VAS) for pain > 5 Exclusion Criteria: presence of concomitant autoimmune diseases psychiatric disorders other causes of chronic pain other diseases that prevented physical loading severe scoliosis or kyphoscoliosis surgery of the spine vertebral fractures sciatic pain tumors enrolled in another type of physical therapy program myocardial infarction lower extremity arterial disease major neurological problems diabetes gastrointestinal disease chronic respiratory disease kidney disease poor vision
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincenzo Maria Saraceni
    Organizational Affiliation
    Umberto I Hospital, Sapienza University of Rome
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A New Rehabilitation Tool in Fibromyalgia

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