Fibromyalgia Clinical Trial
Official 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
NCT number | NCT04049006 |
Other study ID # | PI1800943 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 31, 2021 |
Verified date | August 2019 |
Source | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 302 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Institut Català de la Salut | Tortosa | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Institut Català de la Salut, Instituto de Salud Carlos III |
Spain,
Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Fernandez Saez J, Goncalves AQ, Casajuana M. Cost-utility analysis of a multicomponent intervention for fibromyalgia syndr — View Citation
Arfuch VM, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Goncalves AQ, Berenguera A. Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in prim — View Citation
Arfuch VM, Caballol Angelats R, Aguilar Martin C, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Berenguera A. Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary — View Citation
Arfuch VM, Queiroga Goncalves A, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Berenguera A. Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: — View Citation
Caballol Angelats R, Goncalves AQ, Aguilar Martin C, Sancho Sol MC, Gonzalez Serra G, Casajuana M, Carrasco-Querol N, Fernandez-Saez J, Dalmau Llorca MR, Abellana R, Berenguera A; SensiTEbre group. Effectiveness, cost-utility, and benefits of a multicompo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | change from life quality at 3, 9 and 15 months after the beginning of the study | |
Primary | 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). | Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study. | |
Primary | 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). | Change from tender points at 3, 9 and 15 months after the beginning of the study. | |
Primary | 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). | Change from VAS at 3, 9 and 15 months after the beginning of the study. | |
Primary | 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). | Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study. | |
Primary | 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). | Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study. | |
Secondary | Sociodemographic characteristics of the patients | age, sex, level of education, work disability and family coexistence | baseline (pre intervention period) | |
Secondary | 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) | baseline (pre intervention period) | |
Secondary | Presence/absence of physical or psychic trigger factor of fibromyalgia | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | Presence/absence of family history of fibromyalgia | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | Diagnosis date | diagnosis date of fibromyalgia | baseline (pre intervention period) | |
Secondary | Years of evolution | years of evolution of fibromyalgia | baseline (pre intervention period) | |
Secondary | presence/absence of pathological history: arthrosis, arthritis and mental health problems | To be evaluated with a questionnaire (yes/no type) | baseline (pre intervention period) | |
Secondary | Test of the thyroid stimulating hormone | Analytic results in milliunits per litre (mUI/L) | baseline (pre intervention period) | |
Secondary | Hemogram | Analytic results of hemogram | baseline (pre intervention period) | |
Secondary | Glucose, creatinine and C-reactive protein tests | Analytic results of each test in mg/dl | baseline (pre intervention period) | |
Secondary | Liver Function Tests | Analytic results of each test | baseline (pre intervention period) | |
Secondary | Globular sedimentation rate | Analytic results in mm | baseline (pre intervention period) | |
Secondary | Rheumatoid factor | Analytic results in IU/mL | baseline (pre intervention period) | |
Secondary | Pharmacy billing cost | antidepressants, analgesics and others | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | |
Secondary | Cost of visits | cost of visits to family doctor or nurse and cost of urgency visits | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | |
Secondary | Cost of referrals | cost of referrals to external consultations | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention | |
Secondary | Cost of lost productivity | cost of lost productivity due to sick leave | one year before the beginning of the intervention in comparison with one year after the beginning of the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |