OBJECTIVES: This pilot study explores the methodological implications of evaluating the use of acupuncture in the treatment of disabling breathlessness. DESIGN: A randomized, controlled trial involving three treatments that were used on one occasion, each in random order. SETTINGS: The study was designed to evaluate the feasibility of providing acupuncture treatment on a domiciliary basis, in Southampton (United Kingdom) to patients with disabling breathlessness. SUBJECTS:Sixteen (16) subjects with disabling breathlessness caused by chronic lung disease (primarily chronic obstructive pulmonary disease [COPD]) were recruited from the respiratory medicine clinics of Southampton University Hospitals Trust. INTERVENTIONS: The treatments were real acupuncture, dummy acupuncture, and mock transelectrical nerve stimulation (TENS). OUTCOMES: To evaluate the respiratory outcome measures, to look at the credibility of the three treatments (using a previously validated Borkovec and Nau scale), and to calculate the sample size for a larger, more definitive study. RESULTS:Twelve (12) subjects completed the study. The acupuncture was a predefined point prescription that had been found previously to be of value in this condition, an approach that could be taught to health professionals and provided on a domiciliary basis. The treatment was provided only on one occasion, therefore, we did not expect a clear therapeutic benefit to emerge, but some nonsignificant benefit was noted as a consequence of acupuncture treatment. The shuttle test that we used as an objective measure of breathlessness was impractical in a domiciliary environment and will not be used in further studies. Each of the three treatments was equally credible at the outset, although real and dummy acupuncture were considered by the patients to be preferable choices after the completion of treatment. CONCLUSIONS: It was possible to carry out this study on a domiciliary basis. The information obtained will allow us to design a much clearer definitive study and the small, but statistically insignificant, response to acupuncture has allowed us to estimate sample size.
RCT Entities:
OBJECTIVES: This pilot study explores the methodological implications of evaluating the use of acupuncture in the treatment of disabling breathlessness. DESIGN: A randomized, controlled trial involving three treatments that were used on one occasion, each in random order. SETTINGS: The study was designed to evaluate the feasibility of providing acupuncture treatment on a domiciliary basis, in Southampton (United Kingdom) to patients with disabling breathlessness. SUBJECTS: Sixteen (16) subjects with disabling breathlessness caused by chronic lung disease (primarily chronic obstructive pulmonary disease [COPD]) were recruited from the respiratory medicine clinics of Southampton University Hospitals Trust. INTERVENTIONS: The treatments were real acupuncture, dummy acupuncture, and mock transelectrical nerve stimulation (TENS). OUTCOMES: To evaluate the respiratory outcome measures, to look at the credibility of the three treatments (using a previously validated Borkovec and Nau scale), and to calculate the sample size for a larger, more definitive study. RESULTS: Twelve (12) subjects completed the study. The acupuncture was a predefined point prescription that had been found previously to be of value in this condition, an approach that could be taught to health professionals and provided on a domiciliary basis. The treatment was provided only on one occasion, therefore, we did not expect a clear therapeutic benefit to emerge, but some nonsignificant benefit was noted as a consequence of acupuncture treatment. The shuttle test that we used as an objective measure of breathlessness was impractical in a domiciliary environment and will not be used in further studies. Each of the three treatments was equally credible at the outset, although real and dummy acupuncture were considered by the patients to be preferable choices after the completion of treatment. CONCLUSIONS: It was possible to carry out this study on a domiciliary basis. The information obtained will allow us to design a much clearer definitive study and the small, but statistically insignificant, response to acupuncture has allowed us to estimate sample size.