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Needling Techniques for Knee Osteoarthritis
NA trial testing Acupuncture in Knee Osteoarthritis in 64 participants. Completed in 12 June 2022.
| Lead sponsor | Svijetlana Perculija Durdevic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 2 January 2021 |
| Primary completion | 18 December 2021 |
| Estimated completion | 12 June 2022 |
| Sites | 1 location across Croatia |
Svijetlana Perculija Durdevic
50 and older, any sex, with Knee Osteoarthritis or Kidney Yin Deficiency. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 11.6 | ± 11.633 |
| C Group in Week 15 | 54.4 | ± 19.4 |
Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 2.4 | ± 2.4 |
| C Group in Week 15 | 11.3 | ± 4.6 |
Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 0.7 | ± 0.9 |
| C Group in Week 15 | 4.6 | ± 1.9 |
Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulti
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 8.6 | ± 8.8 |
| C Group in Week 15 | 38.6 | ± 13.9 |
Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 12.6 | ± 12 |
| C Group in Week 15 | 61 | ± 19.5 |
The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on KD.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 10.8 | ± 6.7 |
| C Group in Week 15 | 24.8 | ± 12.5 |
DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic o
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 96.0 | ± 183.7 |
| C Group in Week 15 | 870.0 | ± 950.2 |
The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 0.429 | ± 1.6 |
| C Group in Week 15 | 0.42 | ± 1.35 |
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 0.607 | ± 2.27 |
| C Group in Week 15 | 0.714 | ± 1.78 |
Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 94.1 | ± 17.1 |
| C Group in Week 15 | 90.2 | ± 18.9 |
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 96.1 | ± 17.3 |
| C Group in Week 15 | 91.4 | ± 18.6 |
Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume.
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 55.3 | ± 5.84 |
| C Group in Week 15 | 58.3 | ± 5.87 |
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 58.7 | ± 6.88 |
| C Group in Week 15 | 55.7 | ± 9.25 |
Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a low
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 43.1 | ± 3.9 |
| C Group in Week 15 | 41.8 | ± 3.23 |
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 15 | 43.1 | ± 4.14 |
| C Group in Week 15 | 41.8 | ± 3.0 |
Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome
| Group | Value | 95% CI |
|---|---|---|
| A Group in Week 24 | 20.4 | ± 18.4 |
| C Group in Week 24 | 53.4 | ± 20.5 |
Time frame: The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acupuncture Group | Control Group |
|---|---|---|---|
| suprapatellar knee jount effusion (M13.1) | Injury, poisoning and procedural complications | — | — |
| hematoma subcutaneus | Injury, poisoning and procedural complications | — | — |
| hematoma of upper leg | Injury, poisoning and procedural complications | — | — |
Data from ClinicalTrials.gov NCT05014542 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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