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Completed

NCT Number: NCT04049006

Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients

Fibromyalgia (FM) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. Despite controversies about the most appropriate treatment, studies indicate that a multidisciplinary treatment would be effective. This study aims to analyze the effectiveness and cost-utility of a complex intervention in the quality of life (main variable), the functional impact, the mood and the pain of people with FM treated in the Primary Care Teams (PCTs) of the Catalan Institute of Health (CIH).

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Català de la Salut

Tortosa, Tarragona, 43500, Spain

About this study

Methods and analysis: Mixed methodology study following the recommendations of the Medical Research Council, with two phases. Phase 1: Randomized pragmatic clinical trial with patients diagnosed with FM and assigned to one of the 11 PCTs of the CIH (Territorial management of "Terras del Ebro"). A total sample of 336 patients is estimated.

The usual clinical practice will be carried out in the control group and the usual practice and the complex treatment, in the intervention group. The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. Statistical analysis: Assessment of the standardized mean response and of the size of the standardized effect and multivariate logistic regression analysis will be performed. The economic analysis will be based on useful measures. Phase 2: Qualitative socio-constructivist study to identify the improvement aspects of the intervention according to the results obtained and the opinions and experiences of the participants (patients and professionals). The sampling will be theoretical with 2 discussion groups composed of participants in the intervention and 2 discussion groups of professionals from different PCTs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all criteria must be met):

  • Have a clinical diagnosis of fibromyalgia
  • Have a fixed or mobile telephone
  • Voluntarily accept participation in the project

Exclusion criteria

  • Active psychotic outbreak;
  • Intellectual deficiency;
  • Severe depression and personality disorder;
  • Self and hetero-aggressive behaviors;
  • Individual assessment of active consumption of psychoactive substances;
  • Incompatibility with the group's schedule.

Treatment and study plan

complex treatment

Other

The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. The sessions will be conducted in the primary health care by trained professionals.

Primary outcomes

  1. Change in life quality

    Time frame: change from life quality at 3, 9 and 15 months after the beginning of the study

    to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best).

  2. Change in functional impact of fibromyalgia

    Time frame: Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.

    to be evaluated with the Revised Questionnaire on the Impact of Fibromyalgia (FIQR) It will be measured by a scale Likert: 0 (best) to 100 (worst).

  3. Change in tender points

    Time frame: Change from tender points at 3, 9 and 15 months after the beginning of the study.

    Tender points evaluate the presence of pain in 18 areas of the body and will be measured by a scale Likert: 0 (best) to 18 (worst).

  4. Change in Visual Analog Scale for pain (VAS)

    Time frame: Change from VAS at 3, 9 and 15 months after the beginning of the study.

    The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).

  5. Change in mood indicator (anxiety)

    Time frame: Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.

    To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).

  6. Change in mood indicator (depression)

    Time frame: Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.

    To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).

Secondary outcomes

  1. Sociodemographic characteristics of the patients

    Time frame: baseline (pre intervention period)

    age, sex, level of education, work disability and family coexistence

  2. Presence/absence of physical manifestations

    Time frame: baseline (pre intervention period)

    Physical manifestations to be evaluated: non-repairing sleep, excessive fatigue, dryness of mucous membranes, Raynaud's phenomenon, Intolerance to olfactory and auditory stimuli, cephalgia lumbar, increased sensitivity to the side effects of drugs and paresthesia of hands and feet. To be evaluated with a questionnaire (yes/no type)

  3. Presence/absence of physical or psychic trigger factor of fibromyalgia

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  4. Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  5. Presence/absence of family history of fibromyalgia

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  6. presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  7. presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  8. Diagnosis date

    Time frame: baseline (pre intervention period)

    diagnosis date of fibromyalgia

  9. Years of evolution

    Time frame: baseline (pre intervention period)

    years of evolution of fibromyalgia

  10. presence/absence of pathological history: arthrosis, arthritis and mental health problems

    Time frame: baseline (pre intervention period)

    To be evaluated with a questionnaire (yes/no type)

  11. Test of the thyroid stimulating hormone

    Time frame: baseline (pre intervention period)

    Analytic results in milliunits per litre (mUI/L)

  12. Hemogram

    Time frame: baseline (pre intervention period)

    Analytic results of hemogram

  13. Glucose, creatinine and C-reactive protein tests

    Time frame: baseline (pre intervention period)

    Analytic results of each test in mg/dl

  14. Liver Function Tests

    Time frame: baseline (pre intervention period)

    Analytic results of each test

  15. Globular sedimentation rate

    Time frame: baseline (pre intervention period)

    Analytic results in mm

  16. Rheumatoid factor

    Time frame: baseline (pre intervention period)

    Analytic results in IU/mL

  17. Pharmacy billing cost

    Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

    antidepressants, analgesics and others

  18. Cost of visits

    Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

    cost of visits to family doctor or nurse and cost of urgency visits

  19. Cost of referrals

    Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

    cost of referrals to external consultations

  20. Cost of lost productivity

    Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

    cost of lost productivity due to sick leave

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Institut Català de la Salut
  • Instituto de Salud Carlos III

Registry information

Official study title

Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2019
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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