N/A
N=64
Needling Techniques for Knee Osteoarthritis
Knee Osteoarthritis · Kidney Yin Deficiency · Kidney Yang Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT05014542 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: WOMAC Total in Week 15 — 11.6; 54.4 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Procedure); Conventional Medical Treatment (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Svijetlana Perculija Durdevic
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC Total in Week 15 |
11.6; 54.4 | <0.001 sig |
| SECONDARY WOMAC Pain in Week 15 |
2.4; 11.3 | <.001 sig |
| SECONDARY WOMAC Stiffness in Week 15 |
0.7; 4.6 | <0.001 sig |
| SECONDARY WOMAC Functional Disability in Week 15 |
8.6; 38.6 | <0.001 sig |
| SECONDARY VAS in Week 15 |
12.6; 61 | <0.001 sig |
| SECONDARY KDSQ in Week 15 |
10.8; 24.8 | <0.001 sig |
| SECONDARY DRUG in Week 15 |
96.0; 870.0 | <0.001 sig |
| SECONDARY Active Extension L and R Knees in Week 15 |
0.429; 0.42; 0.607; 0.714 | 0.8493 |
| SECONDARY Active Flexion L and R Knees in Week 15 |
94.1; 90.2; 96.1; 91.4 | 0.490 |
| SECONDARY Circumference of L and R Upper Leg in Week 15 |
55.3; 58.3; 58.7; 55.7 | 0.083 |
| SECONDARY Circumference of L and R Knees in Week 15 |
43.1; 41.8; 43.1; 41.8 | 0.341 |
| SECONDARY WOMAC Total in Week 24 |
20.4; 53.4 | <0.001 sig |
| SECONDARY WOMAC Pain in Week 24 |
4.5; 11 | <.001 sig |
| SECONDARY WOMAC Stiffness in Week 24 |
1.1; 3.4 | <0.001 sig |
| SECONDARY WOMAC Functional Disability in Week 24 |
14.7; 39.0 | <0.001 sig |
| SECONDARY VAS in Week 24 |
13.8; 59.5 | <0.001 sig |
| SECONDARY KDSQ in Week 24 |
13.9; 25.0 | <0.001 sig |
| SECONDARY DRUG in Week 24 |
184.0; 765.5 | <0.001 sig |
| SECONDARY Active Extension L and R Knee in Week 24 |
0; 0; 0; 0 | — |
| SECONDARY Active Flexion L and R Knees in Week 24 |
98.6; 99.5; 101.6; 99.8 | 0.953 |
| SECONDARY Circumference of L and R Upper Leg in Week 24 |
58.8; 57.2; 59.3; 57.2 | 0.261 |
| SECONDARY Circumference of L and R Knee in Week 24 |
43.6; 42.4; 44.0; 42.4 | 0.445 |
| SECONDARY WOMAC Total in Week 39 |
22.0; 18.2; 56.4; 57.3 | <0.001 sig |
| SECONDARY WOMAC Pain in Week 39 |
5.3; 4.7; 11.5; 11.7 | <0.001 sig |
| SECONDARY WOMAC Stiffness in Week 39 |
1.2; 1.2; 3.8; 4.2 | <0.001 sig |
| SECONDARY WOMAC Functional Disability in Week 39 |
15.5; 12.3; 40.8; 41.9 | <0.001 sig |
| SECONDARY VAS in Week 39 |
18.3; 28.0; 59.5; 59.1 | <0.001 sig |
| SECONDARY KDSQ in Week 39 |
14.6; 14.8; 27.2; 26.2 | <0.001 sig |
| SECONDARY DRUG by Added Assessment in Week 39, Crossover Part |
276.1; 319.6; 637.5; 625.0 | 0.204 |
| SECONDARY Lequesne Index in Week 24, Between-group Analysis |
5.1; 12.63 | < 0.001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05014542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.