Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.

Pain and Moderate to Vigorous Physical Activity in Adolescence: An International Population-Based Survey.

OBJECTIVE: To evaluate whether individual types of pain (headache, stomach-ache, and backache) or multiple pains affect the odds of young people achieving the recommended 60 minutes of moderate to vigorous physical activity (MVPA) per day in a large representative sample. DESIGN: Multicenter cross-sectional survey. SETTING: Twenty-eight countries across Europe and North America. SUBJECTS: Adolescents (N = 242,103). METHODS: An analysis of data collected in two waves (2001/02 and 2005/06) of the health behavior in school-aged children (HBSC) study was performed. Survey questions included the HBSC symptoms checklist and the amount of regular physical activity. Multilevel logistic regression was used to account for clustering effect of MVPA within countries. Models investigated the relationship between pain and physical activity, adjusted for the HBSC study year. Six models were conducted separately for gender and age-group (11, 13, and 15 years) strata. RESULTS: In general, the presence of pain was associated with reduced physical activity. Headache alone was associated with reduced physical activity in all six strata (odd ratios 0.77-0.84), stomach-ache alone in five strata (0.77-0.92), and backache alone in four strata (0.86-0.96). In 11- and 13-year-old girls, headache, stomach-ache, and backache, individually and in combination, were associated with decreased odds of being physically active (odds ratios ranging from 0.73 to 0.91). Within the other four age and gender strata, the relationship was less consistent. CONCLUSION: Pain is associated with reduced physical activity in adolescents but this association varies according to gender, age, and the type of pain experienced.

An international survey of pain in adolescents.

BACKGROUND: A common belief is that pain is uncommon and short lived in adolescents. However, the burden of pain in adolescents is unclear because of limitations in previous research. The aim of this study is to estimate the prevalence of headache, stomach-ache and backache in adolescents and to explore the extent to which these three forms of pain coexist based upon a representative sample of adolescents from 28 countries. METHODS: Data were analysed from three consecutive waves (1997/98, 2001/02 and 2005/06) of the Health Behavior in School-aged Children: WHO Collaborative Cross-National survey (HBSC). Prevalence estimates are based upon adolescents who reported experiencing headache, stomach-ache or backache at least monthly for the last 6 months. RESULTS: There were a total of 404,206 participants with a mean (±SD) age of 13.6 (±1.7) years (range 9.8 to 17.3 years). The prevalence of headache was 54.1%, stomach-ache 49.8%, backache 37%, and at least one of the three pains 74.4%. Girls had a higher prevalence of the three pains than boys and the prevalence of pain increased with age. Headache, stomach-ache and backache frequently coexist, for example, of those with headache: 21.2% had headache alone, 31% suffered from both headache and stomach-ache, 12.1% suffered from backache and headache, and 35.7% had all three pains. CONCLUSIONS: Somatic pain is very common in adolescents, more often coexisting than occurring in isolation. Our data supports the need for further research to improve the understanding of these pains in adolescents.

Psychometric testing confirms that the Brazilian-Portuguese adaptations, the original versions of the Fear-Avoidance Beliefs Questionnaire, and the Tampa Scale of Kinesiophobia have similar measurement properties.

STUDY DESIGN: Translation, cross-cultural adaptation, and psychometric testing of 2 questionnaires. OBJECTIVE: The objectives of this study were to translate and cross-culturally adapt the Fear-Avoidance Beliefs Questionnaire (FABQ) to Brazilian-Portuguese and to test the psychometric properties of the Brazilian-Portuguese versions of the FABQ and the Tampa Scale of Kinesiophobia (TSK). SUMMARY OF BACKGROUND DATA: Self-report measures of fear-avoidance have been widely used in clinical practice and in research. To date there is no Brazilian-Portuguese version of the FABQ and the Brazilian-Portuguese TSK has not yet been comprehensively tested. METHODS: The FABQ was cross-culturally adapted after the recommendations from the Guidelines for the process of cross-cultural adaptation of self-report measures. The Brazilian-Portuguese versions of the FABQ and the TSK were tested for internal consistency, reproducibility, ceiling and floor effects, construct validity, and internal and external responsiveness. RESULTS: Both instruments yielded high values for internal consistency and reproducibility [(Cronbach's alpha FABQ = 0.93 and TSK = 0.82) and (Intraclass Correlation Coefficient FABQ = 0.96 and TSK = 0.93)]. No ceiling and floor effects were detected in either questionnaire. The FABQ and TSK were highly correlated (r = 0.86) and they were moderately correlated with the pain numerical rating scale at baseline (r = 0.42 and r = 0.43, respectively) showing good construct validity. The TSK was shown to be more responsive than the FABQ in all internal and external responsiveness analyses. CONCLUSION: Both the Brazilian-Portuguese versions of the FABQ and the TSK are equally useful in terms of description and identification of patients with fear-avoidance behavior; however, in situations that clinicians or researchers aimed to use fear-avoidance as a follow-up measurement for treatment outcomes it seems that the TSK is the better option due to its better capacity to identify change over time.