Efficacy of Thread-Embedding Acupuncture Using the Longitudinal Oblique Technique From BL40 Toward BL57 on KOOS Scores and Joint Range of Motion in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This study aims to evaluate the efficacy of thread embedding acupuncture using a longitudinal oblique technique from BL40 toward BL57 in patients with knee osteoarthritis. The effects of the intervention will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and knee range of motion (ROM), compared with sham thread embedding acupuncture in a double-blind randomized controlled trial.
详细描述
Knee osteoarthritis is a chronic degenerative joint disease associated with knee pain, stiffness, functional limitation, and reduced quality of life. Although pharmacological and non-pharmacological treatments are available, some patients may experience limitations related to treatment duration, adverse effects, or the need for repeated treatment.
Thread embedding acupuncture is an acupuncture modality in which an absorbable thread, such as polydioxanone (PDO), is inserted into selected acupuncture points to provide prolonged mechanical and biological stimulation. Previous studies have investigated thread embedding acupuncture for knee osteoarthritis using various local acupuncture points. However, the use of a longitudinal oblique technique from BL40 toward BL57 has been limited in previous clinical studies.
This study is designed to evaluate the efficacy of thread embedding acupuncture using a longitudinal oblique technique from BL40 toward BL57 in patients with knee osteoarthritis. The intervention is based on a proposed neurophysiological, neuromuscular, neurovascular, and myofascial rationale involving the posterior aspect of the lower extremity.
This study is a double-blind, randomized controlled trial with a parallel-group design. A total of 44 participants will be recruited and randomly allocated in a 1:1 ratio into two groups using permuted block randomization with a block size of four. The intervention group will receive thread embedding acupuncture, while the control group will receive sham thread embedding acupuncture.
Participants will be men and women aged 51 to 70 years with bilateral knee osteoarthritis diagnosed clinically and radiologically according to the American College of Rheumatology criteria and with Kellgren-Lawrence grade II or III osteoarthritis. Participants must have a Numeric Rating Scale pain score greater than 3 during activity and must be able to complete the KOOS questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and the outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 51 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 51 to 70 years.
- •Clinically and radiologically diagnosed with bilateral knee osteoarthritis according to ACR (American College of Rheumatology) criteria.
- •Kellgren-Lawrence grade II or III knee osteoarthritis.
- •NRS (Numeric Rating Scale) score >3 during activity (activities of daily living or light exercise).
- •Body Mass Index (BMI) ≥18.5 kg/m².
- •Knee functional limitations assessable via the KOOS.
- •Ability to understand and complete the KOOS questionnaire. MMSE score >23 (normal or no significant cognitive impairment).
- •Willingness to complete the study and sign the informed consent form.
排除标准
- •History of knee surgery such as total knee replacement, arthroscopy, or ligament reconstruction.
- •Inflammatory joint disease or autoimmune conditions (e.g., rheumatoid arthritis, gouty arthritis, spondyloarthritis, or lupus arthritis) assessed via clinical symptoms and/or radiological findings.
- •Presence of a tumor, wound, or local infection at the injection site.
- •History of peripheral vascular disease, DVT/thromboembolism, aneurysm or pseudoaneurysm, or coagulation/bleeding disorders.
- •Presence of a blood disorder or use of blood thinners (combination antiplatelet or anticoagulant therapy) with an INR ≤ 2.0; history of spontaneous bleeding, thrombocytopenia, or coagulation disorders.
- •Uncontrolled diabetes mellitus or severe systemic disease with a random blood glucose (RBG) level ≥200 mg/dL (measured via capillary blood using a glucometer).
- •Random blood glucose (RBG) level ≥200 mg/dL in non-diabetic patients (measured via capillary blood using a glucometer for all study participants).
- •History of keloids.
- •Routine use of steroids or NSAIDs, or use of topical analgesics prior to therapy and during the study period.
- •Not currently receiving intra-articular knee injections (corticosteroids or hyaluronic acid) and has not received them in the last 3 months.
- •Presence of a Baker's cyst in the popliteal fossa, identified during physical examination.
- •Patients currently undergoing physiotherapy or who have undergone it within the last month.
- •Prior receipt of thread-embedding acupuncture therapy in the knee area or at acupuncture points BL40-BL57 within the last 6 months, or other forms of acupuncture within the last 2 weeks.
- •History of hypersensitivity or allergic reactions to polydioxanone (PDO) threads or procedure needle materials (e.g., stainless steel).
研究组 & 干预措施
Intervention Group
Participants randomized to the experimental group will receive bilateral thread embedding acupuncture at BL40 using a longitudinal oblique technique toward BL57. A sterile 26G × 60 mm needle containing monofilament PDO thread will be inserted at approximately 15° toward the distal posterior lower leg. BL40 will be identified at the midpoint of the popliteal crease, with anatomical palpation before insertion. EMLA® cream will be applied under occlusion for 60 minutes. BMI, height, weight, and individual anatomy will be considered for safety. The needle will be withdrawn after PDO implantation, leaving the thread completely buried beneath the skin. No redirection or aggressive manipulation will be performed. The procedure will stop if abnormal neurological symptoms occur. Pressure, antiseptic care, and sterile dressing will follow, with post-procedure monitoring for adverse events.
干预措施: Thread Embedding Acupuncture (Device)
Control Group
Participants randomized to the sham comparator group will receive sham acupuncture at bilateral BL40 in the prone position. BL40 will be identified at the midpoint of the popliteal crease, followed by aseptic and antiseptic preparation with 4% chlorhexidine gluconate. EMLA® cream will be applied under plastic wrap for 60 minutes. A sterile 0.25 × 25 mm manual acupuncture needle will be inserted bilaterally at BL40 using a longitudinal oblique technique toward the distal posterior lower leg in the direction of BL57 at approximately 15°. The needle will be rapidly withdrawn without PDO implantation. Pressure will be applied for 10 seconds or until bleeding stops, followed by antiseptic care and sterile plaster. Participants will be monitored for adverse events and undergo the same outcome assessments. After study completion, the sham group may receive actual thread embedding acupuncture.
干预措施: Sham Thread Embedding Acupuncture (Device)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Before therapy, week 2, week 4, week 8
The KOOS is a 42-item patient-reported outcome questionnaire consisting of five subscales: Pain (9 items), Symptoms (7 items), Activities of Daily Living (17 items), Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each subscale is scored from 0 to 100, with higher scores indicating better knee-related health status. Change in KOOS from baseline, assessing knee pain, symptoms, activities of daily living, sport and recreational activities, and knee-related quality of life. KOOS will be assessed at baseline and at weeks 2, 4, and 8 after intervention. Changes in KOOS scores from baseline will be evaluated at each follow-up time point (week 2, week 4, and week 8).
次要结局
- Change in ROM (Range of Motion)(Before therapy, week 2, week 8)
研究者
Oki Rachma Agustin
MD
Universitas Indonesia