Vas, JorgeAguilar, InmaculadaCampos, M ÁngelesMéndez, CamilaPerea-Milla, EmilioModesto, ManuelaCaro, PalomaMartos, FranciscoGarcía-Ruiz, Antonio J2015-07-082015-07-082008Vas J, Aguilar I, Campos MA, Méndez C, Perea-Milla E, Modesto M, et al. Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol. BMC Complement Altern Med. 2008;8:36http://hdl.handle.net/10668/1922Study protocol; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;BACKGROUND Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. METHODS/DESIGN The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. DISCUSSION This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. TRIAL REGISTRATION Current Controlled Trials ISRCTN01897462.enDolor de espaldaAcupuntura AuricularEnfermedad crónicaDimensión del dolorAtención primariaEnfermedades de la Columna VertebralMedical Subject Headings::Named Groups::Persons::Age Groups::AdultMedical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Pain::Back PainMedical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Chronic DiseaseMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle AgedMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Neurological::Neurologic Examination::Pain MeasurementMedical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health CareMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research DesignMedical Subject Headings::Diseases::Musculoskeletal Diseases::Bone Diseases::Spinal DiseasesMedical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment OutcomeMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Complementary Therapies::Auriculotherapy::Acupuncture, Earresearch article18601750open access10.1186/1472-6882-8-361472-6882PMC2481242