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Auriculotherapy in sleep disorders in patients with rheumatoid Arthritis.

Invasive auricular acupuncture in sleep disorder in patients with rheumatoid Arthritis: a randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-69cyr2
Enrollment
Unknown
Registered
2019-07-04
Start date
2018-03-05
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

Rheumatoid arthritis

Interventions

Invasive atrial acupuncture (AAI) was performed in the blind and randomized controlled study type in two groups: Control group (CG) with 8 patients who received invasive atrial acupuncture (AAI) at no
Other
E02.190.044.133

Sponsors

Faculdade de Medicina de Marília
Lead Sponsor
Faculdade de Medicina de Marília
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Rheumatoid Arthritis; age greater than or equal to 18 to 100 years; difficulties related to sleep: starting and / or maintaining sleep and also the presence of non-sleepy sleep for at least 1 month.

Exclusion criteria

Exclusion criteria: Cutaneous lesions in the auricular pavilion that prevent the placement of atrial acupuncture points; amputation of the auricular pavilion; previous otoplasty; suspected or confirmed pregnancy; phobia by needles; previous atrial acupuncture; deficits in vision, hearing or cognitive impairment that prevent the proposed evaluations from being performed.

Design outcomes

Primary

MeasureTime frame
The general objective of the present study was to analyze the effects of Invasive Auricular Acupuncture (AAI) on sleep disorders in women with rheumatoid arthritis. A controlled blinded and randomized study was conducted in two groups: Control group (CG) - atrial acupuncture at non-specific points to sleep and Intervention Group (GI) - atrial acupuncture at specific points to sleep, with evaluations performed in 4 moments immediately before of the first session of the AAI (T0), after the fourth session (T1), after the eighth session (T2) and after 1 month of the last session (T3), being weekly sessions for 8 weeks. Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Visual Analog Pain Scale (EVA-D) at rest and Health Assessment Questionnaire (HAQ) were applied. Expected outcome 1: In the study, it was expected that the sleep quality present in the PSQI, ESS and FSS variables presented superiority in the results in relation to the control group.;Result found 1: In the study, the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Visual Analog Pain Scale (EVA-D) at rest and Health Assessment Questionnaire (HAQ) significant difference between the control and intervention groups in relation to time, but there was no significant difference in relation to the group and the interaction between them.;Result found 2: In the intervention group, invasive atrial acupuncture (AAI) presented a significant difference in relation to the evolution and durability of the results in sleep disorders, fatigue and visual analogue scale to pain at rest.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactMirian Kusano

Faculdade de Medicina de Marília

emi_inumar@yahoo.com.br+55-14-997970770

Outcome results

None listed

Source: REBEC (via WHO ICTRP)