Explain Pain in Fibromyalgia Patients

September 28, 2018 updated by: J.J. Amer-Cuenca, Cardenal Herrera University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcalá de Henares, Spain
        • Unviversidad de Alcalá
      • Alcorcón, Spain
        • Universidad Rey Juan Carlos
      • Valencia, Spain
        • Universidad CEU Cardenal Herrera
      • Valencia, Spain
        • Universidad de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline - 6 weeks - 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months
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
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months
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
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months
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.
Baseline - 6 weeks - 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Collaborators

University of Alcala
University of Valencia
Universidad Rey Juan Carlos

Investigators

  • Study Director: Juan J. Amer-Cuenca, Head of Physical Therapy Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI14 / 008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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