Efficacy and safety of acupuncture for chronic... : PAIN (original) (raw)

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Efficacy and safety of acupuncture for chronic uncomplicated neck pain: A randomised controlled study

Vas, Jorgea,*; Perea-Milla, Emiliob; Méndez, Camilac; Navarro, Cayetana Sánchezd; León Rubio, José Maríae; Brioso, Mauricioa; Obrero, Inmaculada Garcíaf

a_Pain Treatment Unit, Dos Hermanas “A” Primary Healthcare Centre, Dos Hermanas, Sevilla, Spain_

b_Research Support Unit, Hospital Costa del Sol, Red IRYSS, Marbella, Málaga, Spain_

c_Andalusian Public Health Service, Sevilla, Spain_

d_Specialised High Resolution Centre, Rehabilitation Service, Hospital de Valme, Dos Hermanas, Sevilla, Spain_

e_Department of Social Psychology, School of Psychology, Universidad de Sevilla, Sevilla, Spain_

f_Rehabilitation Service, Hospital Virgen del Rocío, Sevilla, Spain_

*Corresponding author. Present address: Unidad de Tratamiento del Dolor, Centro de Salud Dos Hermanas A, Segovia s/n. 41700 Dos Hermanas, Spain. Tel.: +34 954729811.

E-mail address:[email protected]

Submitted September 15, 2005; revised May 31, 2006; accepted July 6, 2006.

☆Conflict of interest statement: There are no conflicts of interest. Authors’ contributions: Conception and design, J. Vas. Analysis and interpretation of the data, E. Perea-Milla, C. Mendez, J. M. León Rubio. Drafting of the article, J. Vas, E. Perea-Milla, C. Mendez. Critical revision of the article for important intellectual content, J. Vas, E. Perea-Milla, C. Mendez. Final approval of the article, J. Vas. Statistical expertise, E. Perea-Milla, C. Mendez. Obtaining of funding, J. Vas. Administrative, technical and logistic support, J. Vas. Collection and assembly of data, C. Sanchez, M. Brioso, I. Garcia Obrero. Grant support: The study protocol was developed in 2001 and was funded by the Consejeria de Salud de la Junta de Andalucia (File No. 52/02) in 2002, and partially by the IRYSS network (File No. G03/202). Recruitment began in 2002 and was completed in 2004.

Abstract

Chronic neck pain is highly prevalent. To determine the efficacy and safety of acupuncture, in comparison with transcutaneous nerve stimulation-placebo (TENS-placebo) in the treatment of chronic uncomplicated neck pain, a single blind prospective study was designed, to be carried out at a Primary Healthcare Centre, with random assignment to two parallel groups and with evaluation and analysis by independent evaluators. A random assignment was made from 123 patients of the 149 initially recruited. These patients had been diagnosed with uncomplicated neck pain and experienced neck motion-related pain intensity equal to or exceeding 30 on a visual analogue scale (VAS) from 0 to 100 mm. The treatment with acupuncture was compared with TENS-placebo, applied over 5 sessions in three weeks. The primary endpoint was the change in maximum pain intensity related to motion of the neck, one week after the final treatment. Sensitivity was analysed per protocol (PP) and variant analyses were by intention to treat (ITT). Adjustment was made for confounders by multiple linear regression, including baseline values and rescue therapy. By ITT analysis, the change in the pain-VAS variable was greater among the experimental group (28.1 (95% CI 21.4–34.7)). The improvements in quality of life (physical aspect), active neck mobility and reduced rescue medication were clinically and statistically significant. In the treatment of the intensity of chronic neck pain, acupuncture is more effective than the placebo treatment and presents a safety profile making it suitable for routine use in clinical practice.