This article outlines the meticulous process of formulating a methodologically robust protocol aimed at evaluating the effectiveness of acupuncture in addressing painful shoulder conditions. In 2000, Romoli, et. al., based in a northern Italian hospital, presents the questions and considerations that guided the development of their randomized controlled trial (RCT), which includes three distinct intervention groups, one of which serves as a control.

The study employs a randomized controlled trial design and is conducted in a hospital setting in northern Italy, where a significant number of painful shoulder cases are treated daily. The interdisciplinary team comprises physician/acupuncturists, physiotherapists, and assessors, all dedicated to the success of the research endeavor.

The trial involves sixty participants experiencing monolateral painful shoulder symptoms, with specified exclusion criteria to ensure homogeneity within the study population.

Participants are randomly assigned to one of three groups: acupuncture + mobilization, mobilization alone (control), or ear acupuncture + mobilization. This comprehensive approach allows for a nuanced assessment of acupuncture’s impact on painful shoulder conditions.

The study assesses the severity of pain using visual analogue scale (VAS) and the McGill Pain Questionnaire, along with measuring the restriction of range of motion (ROM) in the shoulder joint. Notably, the protocol incorporates the voluntary use of pain medication (Tenoxicam 20 mg) to further elucidate the treatment outcomes.

The research team successfully developed a protocol and methodology designed to address common flaws and challenges encountered in previous clinical trials on acupuncture. The rigorous design enhances the credibility and reliability of the study findings.

This study underscores the importance of collaboration between experienced clinicians, researchers, and statisticians in designing and preparing clinical trials on acupuncture and other complementary and alternative therapies. The insights gained from this project will benefit physicians and acupuncture specialists, providing valuable guidance for future research endeavors in this domain.

Reference: Romoli, M., Windt, D. V. D., Giovanzana, P., Masserano, G., Vignali, F., Quirico, E., & Giommi, A. (2000). International research project to devise a protocol to test the effectiveness of acupuncture on painful shoulder. The Journal of Alternative and Complementary Medicine, 6(3), 281-287.