Fibromyalgia Different Approaches: Acupuncture vs Migratens

NCT04098757 | Unknown DMC

• 1 other identifier: 1917CESC FrIDAy
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia, Primary; Fibromyalgic Sindrome

Keywords

Fibromyalgia; Fibromyalgic Sindrome (FMS); Pain; Acupuncture; Nutraceutical products

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months

Secondary Outcomes (4)

• 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

• 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

• percentage of adverse effect

  6 months

Study Arms (2)

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

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.

Interventions

Migratens DIETARY_SUPPLEMENT

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.

Migratens

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: female affected by fybromialgia age between 30-65 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• years old
• female sex
• signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Vittorio Schweiger: lead

Study Sites (1)

Nrc

Verona, Italia, 37134, Italy

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: September 23, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)