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Functional exercise program associated with neuromodulation in pain, physical abilities and quality of life of patients with fibromyalgia.

tDCS Associated Functional Exercise Program in pain, functional Performance and quality of Life of Fibromyalgia Patients: Randomized, placebo-controlled, Double-Blind Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8pfq8c
Enrollment
Unknown
Registered
2019-12-10
Start date
2019-12-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women

Interventions

Exercise Protocol (Active Group and Control Group) - Occurs for 8 weeks, 3 times per week. Begin care with walking for about 5 minutes, fitness with exercises for upper limbs, and trunk for 30 minutes
Other
G11.427.410.698.277
E02.331.750

Sponsors

Monayane Grazielly Leite Matias
Lead Sponsor
Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Sex/Gender
Female
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Being a woman diagnosed with fibromyalgia in the age group between 30 and 70 years old; present availability to attend the intervention; not hypersensitive to electric current; have not had previous treatment with tDCS; have not performed regular exercise in the last 3 months; and have a medical certificate allowing the practice of exercise.

Exclusion criteria

Exclusion criteria: Presence of epileptic disease, history of seizure, psychiatric disorders, presence of rheumatic disease, except Fibromyalgia; pregnancy, metallic brain implant; at any time and for whatever reason express a desire to leave the study; missing during the ETCC protocol.

Design outcomes

Primary

MeasureTime frame
Pain - visual analog scale, assessment: 48 hours before treatment (baseline), every 5 days before and after tDCS, 4 weeks and 8 weeks; ;Cardiorespiratory capacity - 6-minute walk test - Assessment: 48 hours before treatment (baseline), 4 weeks and 8 weeks; ;Pain Threshold - Wagner Pain Test ™ - Model FPX Digital Algometer - assessment: 48 hours before treatment (baseline), fifth day of ETCC, 4 weeks and 8 weeks;;Strength - sit-up test, evaluation: 48 hours before treatment (baseline), 4 weeks and 8 weeks;;Muscle Performance - Isokinetic Dynamometer (Biodex Multi-Joint System 3, Biodex Biomecal System Inc, New York, USA) to assess peak torque, power and total work, evaluation: 48 hours before treatment (baseline), 4 weeks and 8 weeks;

Secondary

MeasureTime frame
Fatigue - The multidimensional fatigue inventory (MFI), assessment 48h before intervention, fifth day of tDCS, 4 weeks and 8 weeks; ;Borg effort level (CR-10) - after every day of exercise, assessment 48h before intervention, fifth day of tDCS, 4 weeks and 8 weeks; ;Quality of life - Fibromyalgia Impact Questionnaire (FIQ), assessment 48h before intervention, fifth day of tDCS, 4 weeks and 8 weeks;  ;Depression - Beck's depression scale, assessment 48 hours before intervention, fifth day of tDCS, 4 weeks and 8 weeks;  ;Anxiety - visual analogue anxiety scale, assessment 48h before intervention, fifth day of tDCS, 4 weeks and 8 weeks;;Felling scale, every 5 days before and after ETCC

Countries

Brazil

Contacts

Public ContactUnuversidade Federal do Norte

Universidade Federal do Rio Grande do Norte

ppgfis@ccs.com.br+5508433422001

Outcome results

None listed

Source: REBEC (via WHO ICTRP)