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Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01897462
Enrollment
400
Registered
2008-06-05
Start date
2008-05-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Uncomplicated chronic musculoskeletal rachialgia (neck, mid-back or lower back) Musculoskeletal Diseases Dorsalgia

Interventions

True auriculotherapy using pressure with vaccaria seeds (TAP): Application of auricular implants with vaccaria seeds (vaccaria segetalis Garcke, known in China as Wang bu liu xing) as an individualis

Sponsors

Carlos III Health Institute (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, aged at least 18 years 2. Uncomplicated chronic muscular-skeletal rachialgia (neck, mid-back or lower back), diagnosed by clinical background and physical examination 3. Have not previously received treatment with auricular implants

Exclusion criteria

Exclusion criteria: 1. Protrusion or prolapse of one or more intervertebral discs with concurrent neurological symptoms 2. Infectious spondylopathy 3. Previous surgery of the spinal column 4. Rachialgia caused by inflammatory disease, malign or autoimmmune 5. Congenital deformities of the spinal column, except mild degrees of scoliosis or lordosis 6. Vertebral fractures 7. Spinal stenosis 8. Spondylolysis or spondylolystesis 9. Skin complaints in the auricular pavilion or allergy to sticking plaster 10. Pregnancy 11. Lawsuits brought by reason of rachialgia 12. Incapacity to fill in the questionnaires or respond to the evaluator's questions

Design outcomes

Primary

MeasureTime frame
Changes in pain intensity, measured on the 100 mm visual analogue scale (VAS), at 9 weeks after beginning treatment

Secondary

MeasureTime frame
1. Changes in pain intensity, measured on the 100 mm VAS, at 6 months after beginning treatment 2. Changes in the McGill Pain Questionnaire (MPQ), at the end of treatment and after 6 months 3. Satisfaction on the improvement perceived by the patient, measured at 9 weeks 4. Changes in health-related quality of life, according to the Spanish version of the 12-item Short Form health survey, version 2, at the end of treatment and after 6 months 5. Changes in the results of the Lattinen test and in the consumption of analgesics and NSAIDs (whether or not prescribed by the GP), at the time of randomisation, after each treatment session, at the end of treatment and after 6 months

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026