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Effect of Ear Seeds associated with Exercise in people with Chronic Pain

Additional effect of 8 weeks of Auriculotherapy associated with Exercise practice in people with Chronic Musculoskeletal Pain in primary health care: randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3xbdyym
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-01-01
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

Depression

Interventions

This is a three-arm, triple-blind, randomized controlled clinical trial. Participants will be randomly allocated to auriculotherapy plus exercise, placebo auriculotherapy plus exercise, or exercise al
E02.190.204
G11.427.410.698.277

Sponsors

Universidade Federal dos Vales do Jequitinhonha e Mucuri
Lead Sponsor
Prefeitura Municipal de Diamantina
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Primary Health Care users in the city of Diamantina-MG; both sexes; age between 18 and 65 years; nonspecific low back pain (pain between the lower margins of the ribs and the gluteal folds) (AIRAKSINEN et al., 2006); neck pain; osteoarthritis; pain lasting at least three months; pain intensity with a minimum score of 5 points on the numerical pain scale

Exclusion criteria

Exclusion criteria: Fibromyalgia; neoplasms; radiculopathies; active inflammatory diseases; previous fractures of the spine or lower limbs; previous surgery; other treatment for pain besides exercise in the last 3 months; presence of infection; inflammation or injury in the ear; allergy to microporous tape; use of opioid-type pain relief medications; contraindications for regular physical exercise; pregnancy

Design outcomes

Primary

MeasureTime frame
Pain intensity: A reduction in pain intensity is expected, assessed using the numerical pain scale, with 0 representing no pain" and 10 representing the worst imaginable pain. Pain measurement will be conducted before and after the eight-week intervention and during follow-ups at fifteen days, one month, and three months

Secondary

MeasureTime frame
Disability: A reduction in disability is expected, measured by the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) questionnaire with 12 items, version adapted to the Portuguese language. The questionnaire will be applied before and after eight weeks of intervention and in a follow-up of fifteen days, one month and three months after the end of the activities;Depressive symptoms: A reduction in depressive symptoms is expected, measured using the BDI (Beck Depression Inventory) adapted to Portuguese, applied before and after eight weeks of intervention, and in a follow-up of fifteen days, one month and three months after the end of the activities;Beliefs and attitudes towards pain: These will be measured using the SOPA-brief (Survey of Pain Attitudes-brief). A reduction in the score obtained in the questionnaire is expected which will be applied before and after eight weeks of intervention, and in a follow-up of fifteen days, one month and three months after the end of the intervention

Countries

Brazil

Contacts

Public ContactKaio Pinhal

Universidade Federal dos Vales do Jequitinhonha e Mucuri

kaiopinhal@hotmail.com+55 (35) 991578425

Outcome results

None listed

Source: REBEC (via WHO ICTRP)