RT Journal Article T1 Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220] A1 Vas, Jorge A1 Perea-Milla, Emilio A1 Mendez, Camila A1 Galante, Antonia Herrera A1 Madrazo, Fernando A1 Medina, Ivan A1 Ortega, Caridad A1 Olmo, Victoria A1 Perez Fernandez, Francisco A1 Hernandez, Luz A1 Seminario, Jose Maria A1 Brioso, Mauricio A1 Luna, Francisco A1 Gordo, Isabel A1 Godoy, Ana Maria A1 Jimenez, Carmen A1 Ruiz, Manuel Anselmo A1 Montes, Joaquin A1 Hidalgo, Alonso A1 Gonzalez-Quevedo, Rosa A1 Bosch, Pablo A1 Vazquez, Antonio A1 Lozano, Juan Vicente K1 Artralgia K1 Enfermedad crónica K1 Estudios de seguimiento K1 Estudios multicéntricos como asunto K1 Dimensión del dolor K1 Síndrome de Abducción Dolorosa del Hombro K1 Analgesia por Acupuntura AB BACKGROUNDAlthough the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis).METHODS/DESIGNRandomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat.DISCUSSIONThe discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis. PB BioMed Central SN 1472-6882 YR 2005 FD 2005-10-14 LK http://hdl.handle.net/10668/1925 UL http://hdl.handle.net/10668/1925 LA en NO Vas J, Perea-Milla E, Mendez C, Herrera Galante G, Madrazo F, Medina I, et al. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220]. BMC Complementary and Alternative Medicine 2005, 5:19 NO Journal Article; Study Protocol DS RISalud RD Apr 7, 2025