Needling Techniques for Knee Osteoarthritis

• Status: Active, not recruiting
• Trial end date: 2022-02-27
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Analgesics

Criteria

Inclusion Criteria:

• Clinical diagnosis of Knee Osteoarthritis

• Knee Osteoarthritis for at least 6 months

• painful knee in last month

• radiographic changes of the knee (Kellgren-Lawrence grade 2 or more)

• signed informed consent

• participant can move independently

Exclusion Criteria:

• if the participant got knee intra-articular injection 3 months before his entry into the study

• uncontrolled malignant disease

• unstable heart disease

• advanced organ failure disease (NYHA III or IV, or a more than the twofold increase of creatinin, or marked dyspnea)

• unstable psychiatrist's disease

• bleeding diathesis

• anticoagulant use