The recruitment process, including inclusion and exclusion criteria, for CWP patients and healthy controls (CON) has previously been described in detail (Gerdle et al., 2014 (
link)). None of the included subjects used any type of opioid, steroidal, or anticoagulatory medication. Exclusion criteria also included medical history record of bursitis, tendonitis, capsulitis, post-operative conditions in the neck/shoulder area, previous neck trauma, disorder of the spine, neurological disease, rheumatoid arthritis or any other systemic diseases, metabolic disease, malignancy, severe psychiatric illness or pregnancy, or difficulties understanding the Swedish language.
The healthy CON group consisted of women between 20 and 65 years. They were recruited through local newspaper advertisements. Women with CWP were recruited from former patients with CWP at the Pain and Rehabilitation Centre of the University Hospital, Linköping, Sweden and from an organization for FMS patients. As reported in previous studies, (Gerdle et al., 2010 (
link), 2014 (
link); Ghafouri et al., 2013 (
link)) a total of 19 CWP and 24 CON were initially recruited in the original study. However, four participants were not used because there were difficulties collecting blood samples (two CWP subjects) and because two plasma samples (one CWP and one CON) were insufficient for further proteomic analysis. This resulted in 16 CWP and 23 CON samples. Hence, the proteomic data that this present study is based on has previously been published (Wåhlén et al., 2017 (
link)). However, in this present study, one of the CWP patients was excluded due to unclear diagnosis after detailed analysis and due to the fact that this patient had incomplete data in the health questionnaire. This exclusion resulted in statistical analysis of 38 plasma samples in this present study, 15 plasma samples from CWP and 23 from CON.
To confirm the individual eligibility, all participants (CWP and CON) received a standardized clinical examination. The ACR 90 criteria were used for classification of FMS/CWP (Wolfe et al., 1990 (
link)). The recruiting process started in January 2010 and finished in May 2011. Hence, the revised ACR criteria from 2016 was not available. The examination was followed by a health questionnaire (see below). At the clinical examination, weight and height were registered. Based on these measurements, BMI (kg/m
2) was calculated as weight (kg)/height (m)
2 and classified according to the criteria developed by the World Health Organization (WHO): < 18.5 = underweight; 18.5–24.9 = normal range; 25.0–29.9 = overweight; and ≥30.0 = obesity.
All participants signed a written consent form before the start of the study after receiving verbal and written information about the objectives and procedures of the study. The study was approved by the Regional Ethical Review Board in Linköping, Sweden (Dnr: M10–08, M233–09, Dnr: 2010/164–32) and followed the guidelines according to the Declaration of Helsinki. All methods were carried out in accordance with the approved ethical application.
Wåhlén K., Ghafouri B., Ghafouri N, & Gerdle B. (2018). Plasma Protein Pattern Correlates With Pain Intensity and Psychological Distress in Women With Chronic Widespread Pain. Frontiers in Psychology, 9, 2400.