Needling Techniques for Knee Osteoarthritis

Summary

The thirty-nine-week open-label clinical study investigates the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to analgesics compared to analgesics only and assesses the effects after 9 and 24 weeks, with safety assessment provided.

The study seeks to find possible additional benefits of acupuncture on Kidney Deficiency (KD) while treating KOA with an acupuncture protocol designed to treat KOA following Traditional Chinese Medicine (TCM) theory, which connects KOA with KD as its root cause. The points prescription uses local and Kidney-related points to treat KOA.

The chronic conditions require a higher number of acupuncture treatments. This study will provide acupuncture treatments in three cycles, each three weeks long, with frequency three times weekly. Twenty-seven acupuncture treatments of KOA during fifteen weeks tend to improve KOA and KDS; symptoms are assessed in 10 successive time points, and treatment effects and effect persistence are analysed.

64 patients with symptomatic KOA are randomly allocated into the Acupuncture (A) or Control (C) group according to their permanent, unique, and coincidental Personal Identification Number, which is randomly given to all citizens in Croatia. Before the experiment starts, demographics and disease parameters of all participants are compared. To objectify acupuncture effects, the enrolled physiatrist's measures included knee measures at 3 time points: baseline, at the end of acupuncture (Week 15), and nine weeks later (Week 24). Subjective evaluations of symptoms are assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total and subscales scores, Numeric Rating Scale (NRS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every 3 weeks till the 24th week (9 assessments). Analgesics taken by participants (DRUG) in the last three days before the assessments are recorded. Acupuncture treatment was promised to all participants. Therefore, at Week 25, the between-group analysis ended, and the C group crossed over to receive the identical acupuncture protocol. The 10th assessment in Week 39 was used to estimate, by within-group analysis, the immediate effects of the acupuncture in group C and the effect persistence in group A.

The Lequesne index was introduced additionally at Week 24 as another measure of the knee's functional state.

Conditions

• Knee Osteoarthritis
• Kidney Yin Deficiency
• Kidney Yang Deficiency

Interventions

PROCEDURE

Acupuncture

Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment is 30 minutes. All treatments will be equal.

DRUG

Conventional Medical Treatment

Participants could take their standard conventional medical treatment or analgesics. Analgesics therapy is prescribed by their general practitioner. The dose of analgesics could be modified according to participants' symptoms intensity.

Sponsors & Collaborators

• Nanjing University of Chinese Medicine, Xueping Zhou, Li Ren

  collaborator UNKNOWN

• School of Medicine, University of Zagreb, Pero Hrabac

  collaborator UNKNOWN

• Health Center Zagreb East, Ljiljana Karadakic

  collaborator UNKNOWN

• Svijetlana Perculija Durdevic

  lead OTHER

Principal Investigators

• Svijetlana Perculija Durdevic, M.D. · Family Medicine Practice Svijetlana Perculija Durdevic, MD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-02

Primary Completion

2021-12-18

Completion

2022-06-12

Countries

• Croatia

Study Locations