The purpose of this open-label, twenty-four weeks-long clinical study is to investigate the
efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to conventional
treatment in comparison to conventional therapy alone and assessment of its eventual
prolonged efficacy after nine weeks without treatment. Long term effects of acupuncture on
KOA are not yet confirmed. A safety assessment will be done.
It will be interesting to find possible additional benefits of acupuncture while treating
knee/s with in advance determined acupuncture protocol for KOA since Traditional Chinese
Medicine (TCM) theory connects KOA with Kidney deficiency syndrome. Acupuncture treatment
point prescription will use local points for KOA and non-local points with their influence on
KOA through Kidney deficiency as a root cause.
The deep layered chronic pathological condition like KOA requires a higher number of
acupuncture treatments. This study will provide three cycles of acupuncture treatments, which
are three weeks long each, with treatment frequency three times weekly. It is to be expected
that study design with twenty-seven acupuncture treatments of KOA in fifteen weeks achieves
improvement with the KOA and Kidney deficiency symptoms, additionally. Also, treatment
effectiveness is expected at the final assessment nine weeks after the last acupuncture
treatment. That could confirm holistic aspect of TCM.
Sixty-four patients with symptomatic KOA will be randomly allocated into the Acupuncture
group or Control group (standard care) according to their permanent, unique, and coincidental
Personal Identification Number which is given to all citizens in Croatia. Before experiment
starts participant's demographic and disease parameters of both groups will be compared at
baseline. Prescribed acupuncture protocol will be provided to the Acupuncture group.
Objective assessments of therapeutic efficacy will be done by a physiatrist at three
time-points: baseline, after final acupuncture treatment (15th Week), and at the 24th Week as
the final one. Subjective evaluation of symptoms intensity will be assessed by Western
Ontario and McMaster University Arthritis Index (WOMAC) total score and subscales, Visual
Analogue Scale (VAS), Kidney Deficiency Syndrome Questionnaire (KDSQ). Analgesics taken by
participants for pain will be recorded.
Hypothesis: Decrease in symptoms intensity could be achieved after treatment in experimental
group compared to control.
Phase:
N/A
Details
Lead Sponsor:
Svijetlana Perculija Durdevic
Collaborators:
Health Center Zagreb East Health Center Zagreb East, Ljiljana Karadakic Nanjing University of Chinese Medicine Nanjing University of Chinese Medicine, Xueping Zhou, Li Ren School of Medicine, University of Zagreb School of Medicine, University of Zagreb, Pero Hrabac