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J Am Geriatr Soc. 2018 Dec 8. doi: 10.1111/jgs.15684. [Epub ahead of print]

Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database.

Author information

1
School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada.
2
Bruyère Research Institute, Ottawa, Ontario, Canada.
3
Institute of Bone and Joint Research, The Kolling Institute/Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
4
School of Human Kinetics, University of Ottawa, Ottawa, Ontario, Canada.

Abstract

BACKGROUND/OBJECTIVES:

The burden of low back pain (LBP) is high, especially for older adults who experience a higher number of years living with a disability. However, this population is not being well represented in clinical trials (CTs). This study analyzed the International Clinical Trial Registry Platform (ICTRP) database from the World Health Organization to verify the future trend in the participation of older adults in registered CTs on LBP.

DESIGN:

We performed a cross-sectional review of the ICTRP searching for prospective protocols planning interventions for LBP with registration dates from January 2015 through November 2018. From the protocols of the eligible studies, we extracted those planning to include older adults.

RESULTS:

A total of 167 protocols for CTs for LBP were planning to recruit participants older than 65 years. However, only five registries (2.99%; pooled sample = 169 participants) were designed to target participants specifically older than 65 years. The exclusion of older participants was not justified and imposed through an arbitrary upper-age limit in 93.6% of the protocols. Most of the protocols are from single-center studies, and a greater number are planned to be carried out in developed regions. Higher interest was in pharmacologic interventions, devices/technology, and physical rehabilitation.

CONCLUSION:

Older adults with LBP will continue to be underinvestigated in CTs for LBP in the near future. In general, ongoing trials are small, planned in developed regions, and proposing pharmacologic interventions to deal with LBP.

KEYWORDS:

ageism; clinical trial; low back pain; qualitative research; therapeutics

PMID:
30536367
DOI:
10.1111/jgs.15684

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