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Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

Abstract

The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18–80 years with pain and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed by the patient at 0, 1, 3, 6, 9 and 12 months and knee score and knee function assessed by an orthopaedic surgeon at 0, 6 and 12 months. Within the first month, three patients dropped out. The remaining 21/19 patients in the intervention/control groups generally improved, but there was no statistically significant difference between the groups. The improvement was shown in the patients’ self-assessment scores that decreased from randomisation until 1 year later (intervention/control group, medians): pain −1.92/−2.18 (P = 0.95, F test, general linear mixed model); stiffness −0.93/−0.43 (P = 0.11); function −7.23/−3.36 (P = 0.63). The surgeon’s scores also generally improved, i.e. increased: knee score +16.4/+8.2 (P = 0.65); knee function +10.5/+5.8 (P = 0.79). In the protocol-based subgroup analysis, the 15 intervention patients of the 32 patients who had a positive response to the initial conventional acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial including only patients who respond positively to initial conventional acupuncture.

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Acknowledgements

We thank the patients who volunteered to take part in this study. We acknowledge the help of the late Jens Klitsgaard for teaching KN the gold implantation procedure in dogs. We thank Poul A. Pedersen and Irene H. Wittrup for scientific advice, Carl Jensen for interpretation of X-rays, Henrik Menck for doing the orthopaedic examinations, and Lone Brixen, Willy Karlslund and Lise Bergsøe for technical assistance. The funding of this study was provided by Velux Foundation, PLU Foundation, E Danielsen and Wife Foundation, Wholesaler Chr. Andersen and Ingeborg Andersen née Schmidt Foundation, Torben and Alice Frimodt Foundation, Sara Kristine Dalby Krabbe’s grant, 1993 Jubilee Foundation and Else Nicolajsen’s grant. The work on this study was independent of the funders.

Conflict of interest statement

Dr. Nejrup makes use of gold bead implantation in her clinic. The remaining three authors have no competing interests to declare.

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Correspondence to Niels de Fine Olivarius.

Additional information

Trial registration: ClinTrials.gov ID NCT00487370

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Nejrup, K., de Fine Olivarius, N., Jacobsen, J.L. et al. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study. Clin Rheumatol 27, 1363 (2008). https://doi.org/10.1007/s10067-008-0918-9

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  • DOI: https://doi.org/10.1007/s10067-008-0918-9

Keywords

  • Acupuncture
  • Gold bead implantation
  • Knee function
  • Knee osteoarthritis
  • Knee stiffness
  • Randomised controlled trial