Recruitment and inclusion procedures as “pain killers” in clinical trials?

• Main Authors: Nothnagel H, Brown Menard M, Kvarstein G, Norheim AJ, Weiss T, Puta C, Mist SD, Musial F
• Format: Article in Journal/Newspaper
• Language: English
• Published: Dove Medical Press 2019
• Subjects: Chronic neck pain; Hawthorne effect; Natural course of the disease; Regression to the mean; Clinical trial; Recruitment; Medicine (General); R5-920; Arctic; Hawthorne; Norway; Tromsø; Northern Norway; Arctic University of Norway; UiT The Arctic University of Norway
• Online Access: https://doaj.org/article/d272aa2b1591499ba2222610ac42874d

H Nothnagel,1–3 M Brown Menard4,5, G Kvarstein,6 AJ Norheim,3 T Weiss,7 C Puta1,8, SD Mist,9 F Musial31Department of Sports Medicine and Health Promotion, Friedrich Schiller University Jena, Jena, Germany; 2Department of Psychiatry and Psychotherapy, Jena University Hospital, Jena, Germany; 3Department of Community Medicine, The National Research Center for Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway; 4Crocker Institute, Kiawah Island, SC, USA; 5School of Integrative Medicine and Health Sciences, Saybrook University, Oakland, CA, USA; 6Pain clinic, University Hospital of Northern Norway, UiT The Arctic University of Norway, Tromsø, Norway; 7Department of Biological and Clinical Psychology, Friedrich Schiller University, Jena, Germany; 8Center for Interdisciplinary Prevention of Diseases related to Professional Activities, Friedrich Schiller University, Jena, Germany; 9Oregon Health & Science University, Portland, OR, USABackground: Recruitment and inclusion procedures in clinical trials are time critical. This holds particularly true for studies investigating patients with fluctuating symptom patterns, like those with chronic neck pain. In a feasibility study on neck pain, we found a clinically relevant decrease in pain ratings within the recruitment period. This paper analyses the phenomenon and gives recommendations for recruitment procedures in clinical trials on pain.Methods: Changes in pain intensity scores of 44 chronic neck pain patients (6 males and 36 females; mean age: 45.3±13.2 years) between the first telephone contact and baseline assessment were analyzed. Inclusion criterion was a mean pain intensity of ≥40 on a 0–100 numerical rating scale during the last three months. Statistical analyses were performed using ANOVA and parametric/non-parametric correlation coefficients.Results: Average pain intensity score decreased significantly from 60.3±13.3 at telephone interview to 38.1±21.7 at baseline assessment. This represents a relative change ...