A study protocol for the validation of a prognostic model with an emphasis on modifiable factors to predict chronic pain after a new episode of acute- or subacute nonspecific idiopathic, non-traumatic neck pain presenting in primary care

Background: The primary objective of this study is to identify which modifiable and non-modifiable factors are independent predictors of the development of chronic pain in patients with acute- or subacute nonspecific idiopathic, non-traumatic neck pain, and secondly, to combine these to develop and internally validate a prognostic prediction model. Methods: A prospective cohort study will be conducted by physiotherapists in 30 primary physiotherapy practices between January 26, 2020, and August 31, 2022, with a 6-month follow-up until March 17, 2023. Patients who consult a physiotherapist with a new episode of acute- (0 to 3 weeks) or subacute neck pain (4 to 12 weeks) will complete a baseline questionnaire. After their first appointment, candidate prognostic variables will be collected from participants regarding their neck pain symptoms, prior conditions, work-related factors, general factors, psychological and behavioral factors. Follow-up assessments will be conducted at six weeks, three months, and six months after the initial assessment. The primary outcome measure is the Numeric Pain Rating Scale (NPRS) to examine the presence of chronic pain. If the pain is present at six weeks, three months, and six months with a score of NPRS ≥3, it is classified as chronic pain. An initial exploratory analysis will use univariate logistic regression to assess the relationship between candidate prognostic factors at baseline and outcome. Multiple logistic regression analyses will be conducted. The discriminative ability of the prognostic model will be determined based on the Area Under the receiver operating characteristic Curve (AUC), calibration will be assessed using a calibration plot and formally tested using the Hosmer and Lemeshow goodness-of-fit test, and model fit will be quantified as Nagelkerke’s R2. Internal validation will be performed using bootstrapping-resampling to yield a measure of overfitting and the optimism-corrected AUC. Discussion: The results of this study will improve the understanding of prognostic and potential protective factors, which will help clinicians guide their clinical decision making, develop an individualized treatment approach, and predict chronic neck pain more accurately.