There is a need for health providers to disseminate the results of high quality trials to justify
health care policy. Non pharmacological treatments (NPT) are recommended for the treatment of
osteoarthritis (OA). NPT (including medical devices, technical interventions, participative
interventions, and nutraceuticals) represent a wide range of treatments for OA. While the reference
study design to evaluate the effects of NPT is the randomized controlled trial (RCT), other study
designs are also appropriate. Specific methodological issues are associated with RCTs designed for the
assessment of the efficacy of NPTs in OA. The key points of a high quality clinical trial protocol to
assess the efficacy of NPT for the treatment of OA are presented and justified. The methodology
proposed is mostly in line with the International Conference of Harmonization (ICH) guidelines,
European Agency for the Evaluation of Medicinal Products (EMEA) recommendations and the
recommended efficacy core sets for assessment of OA. Grading quality for RCT assessing NPT in OA
is challenging. Four features represent specific challenges to conducting high quality RCTs assessing
NPT in comparison with those assessing pharmacological treatment : 1) the potential influence of care
providers on treatment (e.g. experience of a therapist for a physical therapy intervention), 2) the choice
of comparator (waiting list, usual care, sham intervention, another NPT, or a pharmacological
treatment), 3) the blinding of the intervention and 4) the methods of randomization and assignation of
the intervention. Depending on the nature of the NPT, bias can be limited using adapted methodological
issues but are often not fully avoided.
Keywords: Osteoarthritis, clinical trials, nonpharmacological treatments.
