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

Completed

Conditions: ncomplicated chronic musculoskeletal rachialgia (neck, mid-back or lower back)
Musculoskeletal Diseases
Dorsalgia

Registration Number: ISRCTN01897462

Lead Sponsor: Carlos III Health Institute (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 400

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Changes in pain intensity, measured on the 100 mm VAS, at 6 months after beginning treatment <br>2. Changes in the McGill Pain Questionnaire (MPQ), at the end of treatment and after 6 months <br>3. Satisfaction on the improvement perceived by the patient, measured at 9 weeks <br>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 <br>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