NCT02474875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

June 12, 2015

Last Update Submit

September 28, 2018

Conditions

Fibromyalgia

Keywords

FibromyalgiaPatient educationCentral sensitization

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale

    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 Outcomes (9)

  • Change in Fibromyalgia Impact Questionnaire

    Baseline - 6 weeks - 3 months

  • Change in Pressure Pain Threshold

    Baseline - 6 weeks - 3 months

  • Change in Medical Outcomes Study Short Form 36 (SF-36)

    Baseline - 6 weeks - 3 months

  • Change in Patient Global Impression of Change Scale

    Baseline - 6 weeks - 3 months

  • Change in Depression subscale of the Hospital Anxiety and Depression Scale

    Baseline - 6 weeks - 3 months

  • +4 more secondary outcomes

Study Arms (4)

Educational program Control Group

ACTIVE COMPARATOR

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

Educational program High Dose Group

EXPERIMENTAL

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

Educational program Diluted Low Dose Group

EXPERIMENTAL

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

Educational program Concentrated Low Dose Group

EXPERIMENTAL

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

Interventions

Educational programOTHER

Patients in experimental groups will receive different educational sessions (contents and duration)

Educational program Concentrated Low Dose GroupEducational program Control GroupEducational program Diluted Low Dose GroupEducational program High Dose Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unviversidad de Alcalá

Alcalá de Henares, Spain

Location

Universidad Rey Juan Carlos

Alcorcón, Spain

Location

Universidad CEU Cardenal Herrera

Valencia, Spain

Location

Universidad de Valencia

Valencia, Spain

Location

Related Publications (4)

  • Van Oosterwijck J, Meeus M, Paul L, De Schryver M, Pascal A, Lambrecht L, Nijs J. Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial. Clin J Pain. 2013 Oct;29(10):873-82. doi: 10.1097/AJP.0b013e31827c7a7d.

    PMID: 23370076BACKGROUND

  • van Ittersum MW, van Wilgen CP, Groothoff JW, van der Schans CP. Is appreciation of written education about pain neurophysiology related to changes in illness perceptions and health status in patients with fibromyalgia? Patient Educ Couns. 2011 Nov;85(2):269-74. doi: 10.1016/j.pec.2010.09.006. Epub 2010 Sep 29.

    PMID: 20880654BACKGROUND

  • Boomershine CS. A comprehensive evaluation of standardized assessment tools in the diagnosis of fibromyalgia and in the assessment of fibromyalgia severity. Pain Res Treat. 2012;2012:653714. doi: 10.1155/2012/653714. Epub 2011 Oct 10.

    PMID: 22110942BACKGROUND

  • Bowering KJ, O'Connell NE, Tabor A, Catley MJ, Leake HB, Moseley GL, Stanton TR. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013 Jan;14(1):3-13. doi: 10.1016/j.jpain.2012.09.007. Epub 2012 Nov 15.

    PMID: 23158879BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Juan J. Amer-Cuenca

    Head of Physical Therapy Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 18, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

ES(4)