Status:
COMPLETED
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Fibromyalgia
Lead Sponsor:
University of Nove de Julho
Collaborating Sponsors:
Multi Radiance Medical
Conditions:
Fibromyalgia
Eligibility:
FEMALE
30-55 years
Phase:
NA
Brief Summary
Fibromyalgia (FM) syndrome is defined by the American College of Rheumatology (ACR), as a chronic widespread pain and tenderness in at least eleven of eighteen specific tender points. Despite the incr...
Detailed Description
To achieve the proposed objectives it will be performed a randomized, triple-blind, placebo-controlled trial, with voluntary patients with fibromyalgia. Ninety patients will be randomly allocated to t...
Eligibility Criteria
Inclusion
- being female;
- age between 30 and 55 years;
- have an ovulatory cycle;
- height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of \> or = to 18.5 kg/ m2;
- present a diagnosis of fibromyalgia and meet the current criteria of the American College of Rheumatology;
- had symptoms of fibromyalgia greater than 3 months;
- Widespread Pain Index (WPI) score \> or = to 9, Visual Analogue Scale score \> or = to 50 Fibromyalgia Impact Questionnaire score \> or = to 50
- is not pregnant;
- not having diabetes mellitus and uncontrolled blood pressure;
- not having psychiatric illness or having malignant tumors;
- did not present dengue, Zika or Chikungunya in the last year;
- not to be hypersensitive to light;
- cognitive level enough to understand the procedures and follow the guidelines;
- consent to participate in the study and sign the consent form.
Exclusion
- arthritis, chronic fatigue syndrome, lupus, auto-immune diseases;
- cognitive changes;
- people who perform some exercise;
- having a pacemaker;
- people under the age of 30 and more than 55 years;
- injuries in the last 6 months;
- not attend for more than two consecutive sessions;
- at any time and for any reason expressing an intention to leave the study.
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04322812
Start Date
March 31 2020
End Date
October 30 2020
Last Update
June 11 2021
Active Locations (1)
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1
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil, 01504-001