NCT03925467

Immediate Effects of Proximal and Distal Acupoints on the RPPW in Patients With KOA: a Randomized Controlled Trial

Immediate Effects of Proximal and Distal Acupoints on the Radial Pressure Pulse-wave in Patients With Knee Osteoarthritis: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Knee osteoarthritis (KOA) is the most prevalent joint condition and is characterized by the progressive erosion of the articular cartilage. In TCM, Pulse Diagnosis has been one of the key diagnostic components in the clinical examinations. Modern pulse diagnosis studies have found that when the human body develops disease or is under pressure, the high frequency spectral energy (10-50Hz) will significantly change. Augmentation index (AIx) is related to the wave reflection of blood vessels. AIx can function as a useful index to reveal aging blood vessels. The experiment will use spectral energy and AIx as objective judgments about the efficacy of before-acupuncture and after-acupuncture treatment. Method: This randomized controlled study will recruit 120 participants which will be allocated to 3 groups: Distal Acupoints, Proximal Acupoints and Sham Acupoints. Each group will have 40 participants to ensure a sufficient sample size can be attained for statistical analysis. Participants aged 20 or older with acute or chronic arthritis will be recruited when they meet the Clinical Classification Criteria for KOA, that is knee pain and three out of six symptoms can be found in clinical practices, as recommended by the American College of Rheumatology:(a) any gender aged 50 years or above;(b) have less than 30 mins of morning stiffness ; (c) crepitus on active motion; and (d)bony tenderness;(e)bony enlargement; and (f)no palpable warmth.Objective and subjective baseline assessments and outcome evaluations including VAS, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and range of knee motion will be performed. The primary outcome will be the assessment of Spectral Energy and AIx of radial pressure pulse-wave in both wrists (Chun, Guan, and Chy pulse) using the Pulse Sphygmograph before and after the intervention. The secondary outcome involves evaluating VAS and range of knee motion. Expected Outcome: The research findings can be clinical evidence regarding the effect of acupuncture KOA on radial artery. Moreover, the research will explore the immediate-effect difference between distal and proximal acupoints on KOA.

Detailed description

Introduction: Knee osteoarthritis (KOA) is the most prevalent joint condition and is characterized by the progressive erosion of the articular cartilage. In TCM, Pulse Diagnosis has been one of the key diagnostic components in the clinical examinations. Modern pulse diagnosis studies have found that when the human body develops disease or is under pressure, the high frequency spectral energy (10-50Hz) will significantly change. Augmentation index (AIx) is related to the wave reflection of blood vessels. AIx can function as a useful index to reveal aging blood vessels. The experiment will use spectral energy and AIx as objective judgments about the efficacy of before-acupuncture and after-acupuncture treatment. Method: This randomized controlled study will recruit 120 participants which will be allocated to 3 groups: Distal Acupoints, Proximal Acupoints and Sham Acupoints. Each group will have 40 participants to ensure a sufficient sample size can be attained for statistical analysis. Participants aged 20 or older with acute or chronic arthritis will be recruited when they meet the Clinical Classification Criteria for KOA, that is knee pain and three out of six symptoms can be found in clinical practices, as recommended by the American College of Rheumatology:(a) any gender aged 50 years or above;(b) have less than 30 mins of morning stiffness ; (c) crepitus on active motion; and (d)bony tenderness;(e)bony enlargement; and (f)no palpable warmth.Objective and subjective baseline assessments and outcome evaluations including VAS, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and range of knee motion will be performed. The primary outcome will be the assessment of Spectral Energy and AIx of radial pressure pulse-wave in both wrists (Chun, Guan, and Chy pulse) using the Pulse Sphygmograph before and after the intervention. The secondary outcome involves evaluating VAS and range of knee motion. Expected Outcome: The research findings can be clinical evidence regarding the effect of acupuncture KOA on radial artery. Moreover, the research will explore the immediate-effect difference between distal and proximal acupoints on KOA. Other Information: The study will be conducted in China Medical University Hospital(Meide Medical Building) Acupuncture Department and Yiyuantang Chinese Medicine Clinic, Hsinchu City. Under the acupuncture of a qualified Chinese physician who has had at least 10 years of clinical experience, it is expected that the risk to the subject will not exceed the minimum risk. The investigators will begin data collection as soon as the approval of the Research Ethics Committee and the required equipment are available, and is expected to be completed within one year of the IRB approval.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Acupuncture	Proximal acupoints: disposable acupuncture needles will be inserted into acupoints (GB34, SP9, EX-LE2) bilaterally for a depth of 10-30 mm. Distal acupoints: disposable acupuncture needles will be inserted into acupoints (LI11, HT3, TE10) bilaterally for a depth of 10-30 mm. Sham acupoints: Sham acupuncture needles will be administered into sham acupoints RN12, ST21.

Timeline

• Start date: 2019-04-30
• Primary completion: 2020-03-24
• Completion: 2020-04-01
• First posted: 2019-04-24
• Last updated: 2019-04-25