title: Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain.
abstract: The evidence to guide use of spinal manipulative therapy (SMT) for patients with shoulder pain is limited. A validated sham comparator is needed to ascertain the unique effects of SMT. We investigated the plausibility of a thoracic sham-SMT comparator for SMT in patients with shoulder pain. Participants (n = 56) with subacromial impingement syndrome were randomized to thoracic SMT or a sham-SMT. An examiner blinded to group assignment took measures pre- and post-treatment of shoulder active range of motion (AROM) and perceived effects of the assigned intervention. Treatment consisted of six upper, middle and lower thoracic SMT or sham-SMT. The sham-SMT was identical to the SMT, except no thrust was applied. Believability as an active treatment was measured post-treatment. Believability as an active treatment was not different between groups (χ(2) = 2.19; p = 0.15). Perceptions of effects were not different between groups at pre-treatment (t = 0.12; p = 0.90) or post-treatment (t = 0.40; p = 0.69), and demonstrated equivalency with 95% confidence between groups at pre- and post-treatment. There was no significant change in shoulder flexion in either group over time, or in the sham-SMT for internal rotation (p > 0.05). The SMT group had an increase of 6.49° in internal rotation over time (p = 0.04). The thoracic sham-SMT of this study is a plausible comparator for SMT in patients with shoulder pain. The sham-SMT was believable as an active treatment, perceived as having equal beneficial effects both when verbally described and after familiarization with the treatment, and has an inert effect on shoulder AROM. This comparator can be considered for used in clinical trials investigating thoracic SMT. IRB number: HM 13182.
authors.affiliation: Division of Biokinesiology and Physical Therapy, University of Southern California, 1540 E. Alcazar Street, CHP 155, Los Angeles, CA 90089, USA. Electronic address: lmichene@usc.edu.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Michener
authors.affiliation: United States Army Research Institute for Environmental Medicine, 15 Kansas Street, Natick, MA 01760, USA.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Kardouni
authors.affiliation: Faculdade de Ciências de Saúde do Trairi, Universidade Federal do Rio Grande do Norte, Santa Cruz, RN, Brazil.
authors.forename: Catarina O
authors.initials: CO
authors.lastname: Sousa
authors.affiliation: Riverside Health System, Newport News, VA 23607, USA.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Ely
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D020393:Manipulation, Spinal / Q000379:methods*; D011446:Prospective Studies; D016059:Range of Motion, Articular / Q000502:physiology; D019534:Shoulder Impingement Syndrome / Q000503:physiopathology / Q000628:therapy*; D013904:Thoracic Vertebrae / Q000503:physiopathology*; D016896:Treatment Outcome
keywords: Rotator cuff; Sham; Thoracic spinal manipulation; Validity