Saline Injections vs Education and Exercise in Knee Osteoarthritis
Status:
Completed
Trial end date:
2020-12-18
Target enrollment:
Participant gender:
Summary
Knee osteoarthritis (OA) is a highly prevalent musculoskeletal condition mainly affecting
older people, causing pain, physical disability, and reduced quality of life. Exercise and
patient education are non-pharmacological interventions for knee OA unanimously recommended
by leading international organisations and authorities based on extensive research that
documents that exercise and education are superior to no-attention control groups.
In Denmark, an initiative to implement these recommendations was initiated in 2013. The
initiative is called Good Life with osteoArthritis in Denmark (GLA:D) and aims at
facilitating high quality care of patients with OA in the Danish population. The core
components of the GLA:D program are 8 weeks of education (2 sessions) and supervised
neuromuscular exercise delivered by GLA:D certified physiotherapists. The GLA:D concept has
been exported to Canada, China and Australia.
While several randomised controlled trials have investigated exercise and education for knee
OA none have used a placebo comparison group. The effect size of exercise plus education
therapy is in line with the current theories that the contact with a caring clinician that
believes in efficacy of the treatments he/she provides can result in beneficial health
effects. In exercise and education programs (such as the GLA:D program) frequent and lengthy
contacts with a physiotherapist are typically necessary. Hence, a significant proportion of
the beneficial effects can be expected to be attributable to placebo or placebo.like effects.
In trials of intra-articular treatment of knee OA (e.g. in trials of corticosteroids,
viscosupplementation, or platelet-rich-plasma) saline injections are a commonly used as
placebo comparator. While saline is recognised as a pharmacologically inert agent, a recent
systematic review and meta-analysis concluded that although intra-articular saline injection
is often used as a "placebo" treatment in clinical trials for knee OA it can provide
substantial pain relief. The effect size of saline injections is in line with the current
theories that the "invasiveness" of a procedure is an important determinant for the magnitude
of placebo effects.
This trial aims to compare a widely used 8-week education plus exercise program (the GLA:D
program) with 4 intra-articular saline injections as treatments of knee OA symptoms. Outcomes
are taken at baseline, after 8-weeks of treatment (week 9) and after additionally 4 weeks of
follow-up (week 12).