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Pain Education and Therapeutic Exercise for Fibromyalgia

Només els usuaris registrats poden traduir articles
Inicieu sessió / registreu-vos
L'enllaç es desa al porta-retalls
EstatCompletat
Patrocinadors
Universidad de Zaragoza
Col·laboradors
University of Valladolid

Paraules clau

Resum

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.

Dates

Darrera verificació: 06/30/2020
Primer enviat: 08/15/2018
Inscripció estimada enviada: 08/20/2018
Publicat per primera vegada: 08/21/2018
Última actualització enviada: 07/05/2020
Publicació de l'última actualització: 07/06/2020
Data d'inici de l'estudi real: 09/02/2018
Data estimada de finalització primària: 01/29/2019
Data estimada de finalització de l’estudi: 01/29/2019

Condició o malaltia

Fibromyalgia

Intervenció / tractament

Other: Pain education plus exercise therapy (PE + ET)

Other: Exercise therapy (ET)

Fase

-

Grups de braços

BraçIntervenció / tractament
Experimental: Pain education plus exercise therapy (PE + ET)
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: Pain education plus exercise therapy (PE + ET)
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.
Active Comparator: Exercise therapy (ET)
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
Other: Exercise therapy (ET)
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Criteris d'elegibilitat

Edats elegibles per estudiar 18 Years Per a 18 Years
Sexes elegibles per estudiarAll
Accepta voluntaris saludables
Criteris

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

Resultat

Mesures de resultats primaris

1. Pain Intensity: VAS [Baseline]

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

2. Pain Intensity: VAS [through study completion, an average 10 weeks]

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

3. Fibromyalgia Impact Questionnaire [Baseline]

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

4. Fibromyalgia Impact Questionnaire [through study completion, an average 10 weeks]

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

Mesures de resultats secundaris

1. Fatigue [Baseline]

The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline

2. Fatigue [through study completion, an average 10 weeks]

The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention

3. Quality of Sleep [Baseline]

The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline

4. Quality of Sleep: Pittsburg Sleeping Questionnaire [through study completion, an average 10 weeks]

The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention

5. Functional Capacity [Baseline]

The investigators measure the functional capacity with Senior Fitness Test at baseline

6. Functional Capacity [through study completion, an average 10 weeks]

The investigators measure the functional capacity with Senior Fitness Test at the end of treatment

7. body strength [baseline]

The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline

8. body strength [through study completion, an average 10 weeks]

The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment

9. Pressure pain threshold [baseline]

The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline

10. Pressure pain threshold [through study completion, an average 10 weeks]

The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment

11. Anxiety and Depression [Baseline]

The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline

12. Anxiety and Depression [through study completion, an average 10 weeks]

The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention

13. kinesiophobia [baseline]

The investigators measure the kinesiophobia with TAMPA questionnaire at baseline

14. kinesiophobia [through study completion, an average 10 weeks]

The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment

15. Quality of life: HAQ [baseline]

The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline

16. Quality of life: HAQ [through study completion, an average 10 weeks]

The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment

17. Central sensitization [baseline]

The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline

18. Central sensitization [through study completion, an average 10 weeks]

The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment

19. Analysis of tryptophan metabolites [baseline]

The investigators measure the tryptophan metabolites with blood test analysis at baseline

20. Analysis of tryptophan metabolites [through study completion, an average 10 weeks]

The investigators measure the tryptophan metabolites with blood test analysis at baseline

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