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Explain Pain in Fibromyalgia Patients

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ClinicalTrials.gov Identifier: NCT02474875
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : February 29, 2016
Sponsor:
Collaborators:
Universidad Rey Juan Carlos
University of Alcala
University of Valencia
Information provided by (Responsible Party):
J.J. Amer-Cuenca, Cardenal Herrera University

Brief Summary:

Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results.

The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Explain Pain in Fibromyalgia Patients
Study Start Date : June 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Educational program Control Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: talk about medical issues (drugs, nutrition, importance of sleep...)
Other: Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)

Experimental: Educational program High Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Other: Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)

Experimental: Educational program Diluted Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Other: Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)

Experimental: Educational program Concentrated Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: educational sessions about the neurophysiology of pain
Other: Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)




Primary Outcome Measures :
  1. Change in Visual Analog Scale [ Time Frame: Baseline - 6 weeks - 3 months ]
    On this continuous, horizontal scale used, where 0 is ''no pain" and 100 is ''worst possible pain" (0-100 mm line), subjects will be asked to mark the line with a cross somewhere between both extremes that best reflect their sensation


Secondary Outcome Measures :
  1. Change in Fibromyalgia Impact Questionnaire [ Time Frame: Baseline - 6 weeks - 3 months ]
    A validated self-reported questionnaire developed for FM (scores range from 0 to 100, average FM patients score about 50 and severely affected patients score >70) wich measures multidimensional function/health-related quality of life.

  2. Change in Pressure Pain Threshold [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Pressure Pain Threshold (PPT) is defined as the lowest pressure that, using standardized testing conditions, needs to be applied in order to cause the slightest sensation of pain. It is a reliable and widely used measure. PPTs will be the average intensity of three consecutive measurements, applied every 30 seconds, measured using an analogue Wagner algometer (Wagner Instruments, Greenwich, CT) fitted with a 1 cm2 pressure, with an approximate rate of pressure increase of 1 Kg/s.

  3. Change in Medical Outcomes Study Short Form 36 (SF-36) [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Physical Component Summary score of the Medical Outcomes Study Short Form 36 [SF-36] will be used. More than 10% improvement in SF-36 physical function has been identified as a responder-to-treatment definition for FM clinical trials

  4. Change in Patient Global Impression of Change Scale [ Time Frame: Baseline - 6 weeks - 3 months ]
    The patient global impression of change scale (PGIC) is recommended for evaluating participant ratings of overall improvement in pain treatment trials. The PGIC uses a 7-point Likert scale that varies from 1 "very much improved" to 7 "very much worse" to quantify patient global response to treatment and have been previously used in FM treatment trials.

  5. Change in Depression subscale of the Hospital Anxiety and Depression Scale [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) includes 7 items to assess depressive symptoms, with each item answered on a four-point (0 to 3) scale so that possible scores range from 0 to 21 with higher scores indicating more severe symptoms. An analysis of data from three pregabalin FM trials supports diagnostic validity of the HADS by showing that, using a standard cutoff score of ≥11 on the HADS-D to identify patients with major depressive disorder

  6. Change in Fatigue Severity Scale [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Fatigue Severity Scale (FSS)20 is a 9-item unidimensional measure of fatigue that has been demonstrated to be valid and reliabile in FM patients. The FSS measures fatigue by quantifying the impact of fatigue on specific types of functioning. Each item is scored on a 7-point rating scale, and the FSS score is derived by averaging all items to yield a score from 1 to 7 with higher scores indicating more severe fatigue symptoms.

  7. Change in Jenkins Sleep Scale [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Jenkins Sleep Scale (JSS) is a 4-item self-report questionnaire designed to measure how often a subject has experienced sleep problems in the past month and has been studied in FM patients and found to be valid, reliable, and able to detect change after treatment. JSS items evaluate trouble falling asleep, staying asleep, waking up several times, and awakening unrefreshed with each item scored on a 5-point Likert scale from 0 = "not at all" to 5 = "22-31 days." Scores vary from 0 to 20 with higher scores indicating more frequent sleep problems.

  8. Change in Manual Tender Point Survey [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Manual Tender Point Survey (MTPS) is a standardized approach to performing the tender point exam in which FM patients rate pain severity upon digital palpation of each tender point on a verbal 11 point number rating scale. Pain severity ratings from the 18 tender points are averaged to yield a Fibromyalgia Intensity Score (FIS) that varies from 0 to 10 with higher scores indicating more severe tenderness. Change in the severity of pain at tender point sites has been shown to be a better measure of tenderness than change in the number of tender points.

  9. Change in Neurophysiology of Pain Test [ Time Frame: Baseline - 6 weeks - 3 months ]
    The Neurophysiology of Pain Test—patient version consists of 19 true-false choice items (scores ranging from 0 to 19, with high scores representing a better knowledge regarding pain neurophysiology). This test evaluates whether patients can understand currently accurate information about the neurophysiology of pain.



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

Inclusion Criteria:

  • American College of Rheumatology classification criteria for FM, both 1990 and 2010
  • Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries
  • On stable doses of medications for FM ≥ 4 weeks

Exclusion Criteria:

  • Suffer from an inflammatory rheumatic conditions
  • Have a planned elective surgery during the study period
  • Have ongoing unresolved disability claims
  • Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis
  • Do not speak Spanish fluently

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): NCT02474875


Locations
Spain
Unviversidad de Alcalá
Alcalá de Henares, Spain
Universidad Rey Juan Carlos
Alcorcón, Spain
Universidad CEU Cardenal Herrera
Valencia, Spain
Universidad de Valencia
Valencia, Spain
Sponsors and Collaborators
Cardenal Herrera University
Universidad Rey Juan Carlos
University of Alcala
University of Valencia
Investigators
Study Director: Juan J. Amer-Cuenca Head of Physical Therapy Department

Publications:
Responsible Party: J.J. Amer-Cuenca, Head of Department, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02474875     History of Changes
Other Study ID Numbers: CEI14 / 008
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

Keywords provided by J.J. Amer-Cuenca, Cardenal Herrera University:
Fibromyalgia
Patient education
Central sensitization

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