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临床试验/NCT05014542
NCT05014542已完成不适用

Needling Techniques for Tonifying Kidneys and Dredging Meridians for Knee Osteoarthritis: A Randomized Clinical Trial

Svijetlana Perculija Durdevic1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
WOMAC Total in Week 15

研究概览

简要总结

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.

详细描述

KOA's high prevalence assures the trial's participation motivation of patients regarding associated pain and functional impairment. Besides pain and stiffness, patients experience muscle weakness, poor balance, and joint distortion in an advanced stage. KOA attacks the diseased ones at the age of 50. Pain worsens with joint loading and becomes relieved by rest. KOA supposes bones remodelling, cartilage thinning, synovial thickening, and joint space narrowing. The advanced stage is presented by joint instability, squaring, and even subluxation.

KOA involves both knees and the contributing symptoms of old age from the scope of Kidney deficiency syndromes, such as weakness, insomnia, depression, tinnitus, forgetfulness, feeling cold, hot, low back pain, thirst at night, and disturbed urination could be manifested.

The acupuncture treatment of KOA follows syndrome differentiation. The treatment principle distinguishes the deficient root (primary Kidney deficiency and secondary Blood deficiency) as the cause, and the excessive branch (knee bone Bi syndrome) when in empty Cou Li spaces, the external factor becomes entraped, consequently. An aspiration with treatment is to tonify the Kidney, nourish Qi, tonify and invigorate Blood, remove Damp and Cold by transferring them toward the deficiency rather than expelling, and relieve the channels and collaterals from the obstruction. Moreover, knee meridians should be dredged to improve knee symptoms by a simultaneous reinforcing-reducing technique on local points and reinforcing on KD-related points. Eventually, the improvements of KD indicate better life quality.

The study's design involves two groups: an acupuncture (A) group that receives acupuncture treatment adjunctive to analgesics, and a control (C) group that receives only analgesics. Participants were recruited from the target population of patients over 50 from 2 Family Medicine practices with confirmed KOA. The study sample was formed with inclusion and exclusion criteria. 64 patients were recruited. All medical data of the participants were available to the investigator. After fulfilling the SOAP form (Subjective, Objective, Assessment, Plan) and getting informed written consent, the study sample was randomly allocated into two groups by size of their permanent, unique eleven-digit long Personal Identification Numbers (OIB), which is assigned to all Croatian citizens. Its first ten digits are accidentally chosen, and the last is a control number. Every second participant ordered by the size of OIB belongs to the same group; odd ones belong to the A group, and even ones to the C group. Demographic and disease parameters are compared at baseline to determine if the groups are comparable. All study participants received analgesics and could modify dosages according to their needs. Analgesics were nonsteroidal anti-inflammatory drugs (NSAIDs) and/or tramadol. Taken analgesics were recorded at Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, and 39. The dose represents an average daily dose of analgesics from the last three days. The dose was recorded after conversion to the comparable dose of the selected representative (ibuprofen), the most prescribed one. The given data will be statistically processed and analyzed.

Patients in the A group started with acupuncture treatment in September 2021, with the first treatment cycle. Each of the 3 treatment cycles, in total, is three weeks long, each consists of 9 treatments, patients will receive acupuncture three times per week and the two adjacent acupuncture cycles are separated by three weeks without acupuncture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The assessor of the physiatrists' measures and the assessor in charge of helping fill in WOMAC, VAS, KDSQ, DRUG, and Lequesne index were blind to the fact to which group participants belonged.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Acupuncture Group

Experimental

Participants in Acupuncture group will get acupuncture treatments to their symptomatic knee/knees according to the study protocol. Acupuncture will be provided to participants in three cycles, each three weeks duration, with frequency three times weekly. Period between the cycles is three weeks long. Participants will get acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type.

干预措施: Acupuncture (Procedure)

Acupuncture Group

Experimental

Participants in Acupuncture group will get acupuncture treatments to their symptomatic knee/knees according to the study protocol. Acupuncture will be provided to participants in three cycles, each three weeks duration, with frequency three times weekly. Period between the cycles is three weeks long. Participants will get acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type.

干预措施: Conventional Medical Treatment (Drug)

Control Group

Active Comparator

Participants in Control group will get their standard conventional treatment (analgesics) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type.

干预措施: Conventional Medical Treatment (Drug)

结局指标

主要结局

WOMAC Total in Week 15

时间窗: Week 15

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.

次要结局

  • WOMAC Pain in Week 15(Week 15)
  • WOMAC Stiffness in Week 15(Week 15)
  • WOMAC Functional Disability in Week 15(Week 15)
  • VAS in Week 15(Week 15)
  • KDSQ in Week 15(Week 15)
  • DRUG in Week 15(Week 15)
  • Active Extension L and R Knees in Week 15(Week 15)
  • Active Flexion L and R Knees in Week 15(Week 15)
  • Circumference of L and R Upper Leg in Week 15(Week15)
  • Circumference of L and R Knees in Week 15(Week 15)
  • WOMAC Total in Week 24(Week 24)
  • WOMAC Pain in Week 24(Week 24)
  • WOMAC Stiffness in Week 24(Week 24)
  • WOMAC Functional Disability in Week 24(Week 24)
  • VAS in Week 24(Week 24)
  • KDSQ in Week 24(Week 24)
  • DRUG in Week 24(Week 24)
  • Active Extension L and R Knee in Week 24(Week 24)
  • Active Flexion L and R Knees in Week 24(Week 24)
  • Circumference of L and R Upper Leg in Week 24(Week 24)
  • Circumference of L and R Knee in Week 24(Week 24)
  • WOMAC Total in Week 39(Week 39)
  • WOMAC Pain in Week 39(Week 39)
  • WOMAC Stiffness in Week 39(Week 39)
  • WOMAC Functional Disability in Week 39(Week 39)
  • VAS in Week 39(Week 39)
  • KDSQ in Week 39(Week 39)
  • DRUG by Added Assessment in Week 39, Crossover Part(Week 39)
  • Lequesne Index in Week 24, Between-group Analysis(Week 24)

研究者

发起方
Svijetlana Perculija Durdevic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Svijetlana Perculija Durdevic

Head of Family Medicine Practice, Principal Investigator

Family Medicine Practice Svijetlana Perculija Durdevic, MD

研究点 (1)

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