Efficacy of intra-articular hyaluronan (Synvisc®) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus): study protocol for a randomised placebo controlled trial
2009

Efficacy of Hyaluronan for Hallux Limitus Treatment

Sample size: 150 publication Evidence: moderate

Author Information

Author(s): Munteanu Shannon E, Menz Hylton B, Zammit Gerard V, Landorf Karl B, Handley Christopher J, ElZarka Ayman, DeLuca Jason

Primary Institution: La Trobe University

Hypothesis

Does intra-articular hyaluronan (Synvisc®) reduce pain and improve function in people with hallux limitus?

Conclusion

This study aims to evaluate the effectiveness of intra-articular hyaluronan for treating osteoarthritis of the first metatarsophalangeal joint.

Supporting Evidence

  • The study is the first randomized controlled trial to evaluate hyaluronan for hallux limitus.
  • Previous studies lacked a placebo control group, which this study addresses.
  • The sample size is designed to provide sufficient power to detect clinically significant differences.

Takeaway

This study is testing if a special injection can help people with foot pain feel better and move easier.

Methodology

Participants will receive either hyaluronan or saline injections and will be assessed for pain and function at multiple time points.

Potential Biases

There is a risk of bias due to the injector being aware of the treatment being administered.

Limitations

The study may be limited by the potential for a placebo effect and the lack of blinding for the injector.

Participant Demographics

Community-dwelling men and women aged 18 and over with hallux limitus.

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1757-1146-2-2

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