Are older people missing from low back pain clinical trials?

Abstract

Background: There is evidence to suggest that older people are under-represented in randomised clinical trials of health interventions. Purpose: The aim of this review was to systematically examine the age-related inclusion criteria distribution of participants in randomized controlled trials (RCTs) of low back pain (LBP) interventions and to investigate if this distribution pattern changes overtime. Methods: We systematically reviewed 400 randomly selected RCTs on non-specific LBP published since 1992 and identified by a clinical query on PubMed. Included studies were grouped according to treatment type. Data were extracted on year of publication, types of treatment, total number of participants, age inclusion criteria and age of included participants. Results: 274 RCTs, published between 1992 and 2010 met the inclusion criteria. A total of 41.6% (n= 114) of the included trials excluded people over 65 years. The pooled mean age of participants was 44.3 years (95% CI: 42.4–46.3 years); the pooled minimum age for inclusion was 19.8 years and the pooled maximum age for inclusion, 65.4 years. The review found no trend in including older participants in RCTs on LBP over time. Conclusion(s): Despite an ageing population around the globe, older people are systematically excluded from RCTs evaluating management of LBP and there is no evidence of change in this practice over the last two decades. Implications:Future trialsmust include participants older than 65 years of age if we are to make inferences of treatment effectiveness to the older patient with low back pain.