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Fibromyalgia Different Approaches: Acupuncture vs Migratens (FrIDAy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098757
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Vittorio Schweiger, Azienda Ospedaliera Universitaria Integrata Verona

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.


Condition or disease Intervention/treatment
Fibromyalgia, Primary Fibromyalgic Sindrome Dietary Supplement: Migratens

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Observation of Patients Affected by Fibromyalgic Syndrome (FMS): Comparison of Different Therapeutic Approaches
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.

acupuncture
2 sessions a week, for a total of 10 (5 weeks), performed by the same operator, repeatable if necessary, after a therapeutic interval of at least one month. Each session lasts about 20-30 minutes per patient. Tewa J Type sterile disposable needles, coated, with a Chinese-style copper wire handle, with a guide tube, of 22x13 mm (CJ 2213) and 30x25 mm (CJ 3025) will be used. Acupuncture will be carried out by same trained operator.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. visual analogue scale pain reduction in fibromyalgic patients from baseline to 1 month follow-up, from baseline to 3 months follow-up [ Time Frame: 1 and 3 months ]
    - to observe pain reduction in fibromyalgic patients treated with nutraceutic (Migratens®) - Groupo A, and with acupuncture - Group B, at different follow up time 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.

  2. Cenestesi improvement measured with revised Fibromyalgia Impact Questionnaire SCORE in fibromyalgic patients from baseline to 6 months follow-up [ Time Frame: 6 months ]
    to value general improvement of cenestesi between two groups. each of the 9 questiona of questionnaire present a score from 0 to 10 to evaluate haw fibromyalgia make activities difficult, zero score correspond to no difficult and 10 to always difficult.

  3. visual analogue scale pain reduction in fibromyalgic patients from 3 month to 6 month [ Time Frame: 3 and 6 months ]
    to observe time of pain reduction or pain free after treatment end. 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.

  4. percentage of adverse effect [ Time Frame: 6 months ]
    to observe number and type of treatment adverse effect during study time



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female affected by fybromialgia age between 30-65 years old
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from fibromyalgia for at least 6 months according to the modified criteria of 2016 affering to Verona's Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098757


Locations
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Italy
Nrc
Verona, Italia, Italy, 37134
Sponsors and Collaborators
Vittorio Schweiger
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Responsible Party: Vittorio Schweiger, PROFESSOR, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT04098757    
Other Study ID Numbers: 1917CESC FrIDAy
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vittorio Schweiger, Azienda Ospedaliera Universitaria Integrata Verona:
Fibromyalgia
Fibromyalgic Sindrome (FMS)
Pain
Acupuncture
Nutraceutical products
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases