Explain Pain in Fibromyalgia Patients

NCT ID: NCT02474875

Last Updated: 2018-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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...)

Group Type ACTIVE_COMPARATOR

Educational program

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Educational program

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Educational program

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Educational program

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

University of Alcala

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role collaborator

Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

J.J. Amer-Cuenca

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juan J. Amer-Cuenca

Role: STUDY_DIRECTOR

Head of Physical Therapy Department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unviversidad de Alcalá

Alcalá de Henares, , Spain

Site Status

Universidad Rey Juan Carlos

Alcorcón, , Spain

Site Status

Universidad CEU Cardenal Herrera

Valencia, , Spain

Site Status

Universidad de Valencia

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23370076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20880654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22110942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23158879 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEI14 / 008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

New Educational Tool for FM
NCT04571853 UNKNOWN NA