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Clinical Trials/NCT04098757
NCT04098757UnknownNot Applicable

Observation of Patients Affected by Fibromyalgic Syndrome (FMS): Comparison of Different Therapeutic Approaches

Vittorio Schweiger1 site in 1 country61 target enrollmentStarted: January 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
61
Locations
1
Primary Endpoint
visual analogue scale pain reduction in fibromyalgic patients from baseline to 6 months follow-up

Study Overview

Brief Summary

Fibromyalgia or Fibromyalgic Sindrome (FMS) is a chronic debilitating pain syndrome, characterized by widespread chronic musculoskeletal pain and generalized painful hypersensitivity, which may be associated with systemic, cognitive and psycho-emotional somatic disorders. Etiology is not completely known. The diagnosis of fibromyalgia is anamnestic and clinical, without evident alterations at the objective examination or at laboratory and radiology investigations. According last guidelines, the best approach to treat FMS must be personalized and multidisciplinary, including pharmacological and non-pharmacological interventions. Moreover, a correct treatment of comorbidities, practice of bland physical activity or meditative discipline, as well as a pychological support are very important in FMS.

The aim of this study is to evaluate the activity of some common therapeutic pathways available for FMS: acupuncture and nutraceutical products; the latter are numerous on the market and based on powerful antioxidants. In this case Migratens was chosen for its composition: α-lipoic acid, polyvitaminic complexes (B and D group vitamins), coenzyme Q10, magnesium and tryptophan.

Detailed Description

Fibromyalgia or Fibromyalgic Sindrome (FMS) is a chronic debilitating pain syndrome, affecting about 2-4% of the general population, with an average peak between 30 and 50 years, but with a significantly higher prevalence, until about 8-10%, if considered only female sex or greater age. Fibromyalgia is characterized by the presence of widespread chronic musculoskeletal pain and generalized painful hypersensitivity, which may be associated with systemic, cognitive and psycho-emotional somatic disorders, such as: asthenia, sleep disorders, depression, anxiety, headache, paresthesia, dry eye, tachycardia, intercostal pain, dyspnoea, gastrointestinal or gynecological or urological disorders.

Etiology is not completely known, even if genetic, environmental, physical and emotional factors seem to interact and promote an hypersensitive state, both at central and peripheral level, leading to a functional disorder of pain modulation system. Sleep or immune system disorders, focal tissue abnormalities, physical or psychological trauma seem to trigger the disease, but many patients are not able to identify any apparent cause.

Validated questionnaires, including the Fibromyalgia Impact Questionnaire (FIQ), are used to assess the impact of fibromyalgia on people's health and quality of life; in 2016 this survey was revised (FIQR) to intercept almost the entire spectrum (domains) of problems related to the disease and response to treatment, as well as to include other relevant parameters in the evaluation of the FMS patient (eg assessment of cognitive functions, balance problems, etc.), absent in the original version. In this scale the score of each item ranges from 0 to 10. First block of questions concerns the physical function of the subject and the related physical difficulties experienced in the last week; the subtotal score of first 9 items is divided by three, therefore the maximum score is 30. Second domain concerns FMS impact on general health in the last week and consists of two questions; the relative score remains unchanged, so maximum score is 20. Third domain consists of 10 items concerning the severity of main symptoms related to fibromyalgia experienced in the last week; addition of these is divided by two, thus maximum score is 50. Sum of all three domains corresponds to the total of the questionnaire and its interpretation is as follows: 0-42 mild FMS, 43-59 moderate FMS, 60-74 severe FMS, 75-100 FMS very serious. In this survey also depression is valuated, in a scale from 0 (absence of mood disorder) to 10 (severe depression).

Visual Analogue Scale (VAS) is a visual representation of severity of pain felt by the patient, indicated on a 10 cm long line, where one end indicates the absence of ache (0), while the other corresponds to the worst pain imaginable (10).

According last guidelines, the best approach to treat FMS must be personalized and multidisciplinary, including pharmacological and non-pharmacological interventions. Drugs, with off-label indication for fibromyalgia, are amitriptyline, duloxetine and pregabalin, in monotherapy or combined. If there is no response, patients may try to employ analgesics and anti-inflammatories as needed or use complementary and alternative therapies (for example: acupuncture, transcranial stimulation or TENS, cannabinoid derivatives, nutraceutical products, vitamin D supplementation). Moreover, a correct treatment of comorbidities, practice of bland physical activity or meditative discipline, as well as a pychological support are very important in FMS.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients not under pharmacological treatment for at least six months,
  • patients with a new diagnosis of fibromyalgia (FM)
  • hypovitaminosis D (vitamin D <30 mg / ml) or patients already in oral supplementation with 1,000 IU / day. People with hypovitaminosis are treated with Vitamin D supplementation
  • 30 - 65 years old
  • female sex
  • signature of informed consent

Exclusion Criteria

  • patients treated with active drugs on the neuroendocrine system
  • intake of drugs that can influence skeletal metabolism
  • addition of other fibromyalgia medicines other than those included in the study, during the observational period
  • allergies to components of the food supplement used
  • use of oral hypoglycemic agents
  • participation in other studies
  • recent acupuncture treatments elsewhere
  • severe psychiatric or neurological disorders

Outcomes

Primary Outcomes

visual analogue scale pain reduction in fibromyalgic patients from baseline to 6 months follow-up

Time Frame: 6 months

to observe pain reduction in fibromyalgic patients treated with nutraceutic (Migratens®) - Groupo A, and with acupuncture - Group B, at the end of the study. visual analogue scale is anagogic scale that evaluate continuous aspect of the scale differentiates it from discrete scales such as the Likert scale, from 0 to 10.

Secondary Outcomes

  • percentage of adverse effect(6 months)
  • Cenestesi improvement measured with revised Fibromyalgia Impact Questionnaire SCORE in fibromyalgic patients from baseline to 6 months follow-up(6 months)
  • visual analogue scale pain reduction in fibromyalgic patients from 3 month to 6 month(3 and 6 months)
  • visual analogue scale pain reduction in fibromyalgic patients from baseline to 1 month follow-up, from baseline to 3 months follow-up(1 and 3 months)

Investigators

Sponsor
Vittorio Schweiger
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Vittorio Schweiger

PROFESSOR

Azienda Ospedaliera Universitaria Integrata Verona

Study Sites (1)

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