Clinical trial NCT03641495: Pain Education and Therapeutic Exercise for Fibromyalgia
Official title: Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
therapeutic exercise
physiotherapy
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: University of Valladolid
First posted: 2018-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.


Eligibility criteria: Inclusion Criteria:

* Diagnosed medically with Fibromyalgia
* Diagnosed according to the American College of Rheumatology criteria
* Agreement to attend to treatment sessions

Exclusion Criteria:

* Any kind of contraindications for physical activity
* Other kind of diseases that could limit the intervention
* Previous surgery last year
* Medication modifications in the last 3 months

Primary outcomes:
measure: Pain Intensity: VAS
timeFrame: Baseline
measure: Pain Intensity: VAS
timeFrame: through study completion, an average 10 weeks
measure: Fibromyalgia Impact Questionnaire
timeFrame: Baseline
measure: Fibromyalgia Impact Questionnaire
timeFrame: through study completion, an average 10 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: through study completion, an average 10 weeks
measure: Quality of Sleep
timeFrame: Baseline
measure: Quality of Sleep: Pittsburg Sleeping Questionnaire
timeFrame: through study completion, an average 10 weeks
measure: Functional Capacity
timeFrame: Baseline
measure: Functional Capacity
timeFrame: through study completion, an average 10 weeks
measure: body strength
timeFrame: baseline
measure: body strength
timeFrame: through study completion, an average 10 weeks
measure: Pressure pain threshold
timeFrame: baseline
measure: Pressure pain threshold
timeFrame: through study completion, an average 10 weeks
measure: Anxiety and Depression
timeFrame: Baseline
measure: Anxiety and Depression
timeFrame: through study completion, an average 10 weeks
measure: kinesiophobia
timeFrame: baseline
measure: kinesiophobia
timeFrame: through study completion, an average 10 weeks
measure: Quality of life: HAQ
timeFrame: baseline
measure: Quality of life: HAQ
timeFrame: through study completion, an average 10 weeks
measure: Central sensitization
timeFrame: baseline
measure: Central sensitization
timeFrame: through study completion, an average 10 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Sandra Jiménez del Barrio
Study officials:
References: