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Fibromyalgia Different Approaches: Acupuncture vs Migratens

NCT04098757 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2019-09-23

No results posted yet for this study

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.

Conditions

  • Fibromyalgia, Primary
  • Fibromyalgic Sindrome

Interventions

DIETARY_SUPPLEMENT

Migratens

2 sachets/day: 800 mg of α-Lipoic acid, 450 mg of magnesium bisglycinate, 300 mg of L-Tryptophan, 20 mcg of Vitamin D3, 2.4 mg of Vitamin B2, 25 mg of Niacin, 150 mg of Coenzyme Q10. Patients who receive Migratens food supplementation have to take 2 sachets / day for 12 weeks. The supplement will be prescribed as usual and the assumption of the same will be recorded by partecipants in the appropriate daily; if the subject does not continue the indication the data collected up to that moment will be considered.

Sponsors & Collaborators

  • Vittorio Schweiger

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098757 on ClinicalTrials.gov