Pain Education and Therapeutic Exercise for Fibromyalgia

NCT03641495 | Completed

• 1 other identifier: University of Valladolid
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; therapeutic exercise; physiotherapy

Outcome Measures

Primary Outcomes (4)

• Pain Intensity: VAS

  The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline

  Baseline

• Pain Intensity: VAS

  The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention

  through study completion, an average 10 weeks

• Fibromyalgia Impact Questionnaire

  The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline

  Baseline

• Fibromyalgia Impact Questionnaire

  The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention

  through study completion, an average 10 weeks

Secondary Outcomes (18)

• Fatigue

  Baseline

• Fatigue

  through study completion, an average 10 weeks

• Quality of Sleep

  Baseline

• Quality of Sleep: Pittsburg Sleeping Questionnaire

  through study completion, an average 10 weeks

• Functional Capacity

  Baseline

Study Arms (2)

Pain education plus exercise therapy (PE + ET)

EXPERIMENTAL

Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Other: PE+ET

Exercise therapy (ET)

ACTIVE COMPARATOR

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Other: ET

Interventions

PE+ET OTHER

To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain. To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Pain education plus exercise therapy (PE + ET)

ET OTHER

To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Exercise therapy (ET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• University of Valladolid: collaborator

Study Sites (1)

Sandra Jiménez del Barrio

Soria, 42004, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

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: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 22, 2018
• Study Start: September 3, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)