NCT03044067

Brief Summary

Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

February 1, 2017

Enrollment Period

Same day

First QC Date

February 2, 2017

Last Update Submit

May 2, 2017

Conditions

Fibromyalgia

Keywords

Chronic painFibromyalgiaPain neuroscience educationExercise

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline function at 1 month

    This outcome will be measured with the pain disability index (PDI)

    1 month

  • Change from Baseline pain at 1 month

    This outcome will be measured with the numerical pain rating scale (NRS)

    1 month

Secondary Outcomes (1)

  • Change from Baseline self-efficacy at 1 moths

    1 month

Study Arms (2)

Pain neuroscience education + Exercise

EXPERIMENTAL

Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities.

Other: Pain neuroscience education + Exercise

Exercise

ACTIVE COMPARATOR

Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.

Other: Exercise

Interventions

Pain neuroscience education + ExerciseOTHER

A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.

Pain neuroscience education + Exercise
ExerciseOTHER

A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.

Exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-70 years.
  • Willing and able to participate
  • Diagnosis of Fibromyalgia

You may not qualify if:

  • Systemic diseases
  • Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibromyalgiaChronic PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alejandro Luque Suarez, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Matias Soto, PT

CONTACT

616375349msjavi93@gmail.com

Alejandro Luque Suarez, PhD

CONTACT

aluques@uma.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 6, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share