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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
302
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.
Institut Català de la Salut
Tortosa, Tarragona, Spain
Change in life quality
to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best).
Time frame: change from life quality at 3, 9 and 15 months after the beginning of the study
Change in functional impact of fibromyalgia
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).
Time frame: Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.
Change in tender points
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).
Time frame: Change from tender points at 3, 9 and 15 months after the beginning of the study.
Change in Visual Analog Scale for pain (VAS)
The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).
Time frame: Change from VAS at 3, 9 and 15 months after the beginning of the study.
Change in mood indicator (anxiety)
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).
Time frame: Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.
Change in mood indicator (depression)
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).
Time frame: Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.
Sociodemographic characteristics of the patients
age, sex, level of education, work disability and family coexistence
Time frame: baseline (pre intervention period)
Presence/absence of physical manifestations
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)
Time frame: baseline (pre intervention period)
Presence/absence of physical or psychic trigger factor of fibromyalgia
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
Presence/absence of family history of fibromyalgia
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
Diagnosis date
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
diagnosis date of fibromyalgia
Time frame: baseline (pre intervention period)
Years of evolution
years of evolution of fibromyalgia
Time frame: baseline (pre intervention period)
presence/absence of pathological history: arthrosis, arthritis and mental health problems
To be evaluated with a questionnaire (yes/no type)
Time frame: baseline (pre intervention period)
Test of the thyroid stimulating hormone
Analytic results in milliunits per litre (mUI/L)
Time frame: baseline (pre intervention period)
Hemogram
Analytic results of hemogram
Time frame: baseline (pre intervention period)
Glucose, creatinine and C-reactive protein tests
Analytic results of each test in mg/dl
Time frame: baseline (pre intervention period)
Liver Function Tests
Analytic results of each test
Time frame: baseline (pre intervention period)
Globular sedimentation rate
Analytic results in mm
Time frame: baseline (pre intervention period)
Rheumatoid factor
Analytic results in IU/mL
Time frame: baseline (pre intervention period)
Pharmacy billing cost
antidepressants, analgesics and others
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of visits
cost of visits to family doctor or nurse and cost of urgency visits
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of referrals
cost of referrals to external consultations
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
cost of lost productivity due to sick leave
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention