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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03925467
• Other study ID #: CMUH108-REC2-033
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2019
• Source: China Medical University Hospital
• Contact: Yu-Chen Lee, M.D.,PhD
• Phone: 886-975-682023
• Email: d5167[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 1, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Patients meet at least three out of the following six conditions:

• Any gender aged 50 years or above;

• Have less than 30 mins of morning stiffness;

• Crepitus on active motion;

• Bony tenderness;

• Bony enlargement;

• No palpable warmth.

Exclusion Criteria:

• Subjects who are unable to walk.

• Malignancy,

• Any acute medical condition,

• Poorly controlled diabetes or hypertension,

• A motor or sensory nerve defect,

• Blood clotting disease,

• Mental illness,

• Dementia,

• Mental retardation or other abnormal person on the organic mind.

• Subjects with intra-articular solid or hyaluronic acid injection in the past 3 months.

• Knee surgery,

• Knee trauma,

• Congenital knee deformation,

• Severe knee varus or valgus deformation,

• Endocrine,metabolic, infectious, inflammatory, secondary degenerative knee arthritis caused by problems with rheumatic immune diseases.

• Subjects who are hypersensitive to needles.

• Subjects who are unwilling to cooperate or sign the subject consent.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Radial Pressure Pulse-wave at cunkou (1)	Assessment of Radial Pressure Pulse-wave at cunkou ie at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph at 10 min before acupuncture.	20 min before acupuncture
Primary	Assessment of Radial Pressure Pulse-wave at cunkou (2)	Assessment of Radial Pressure Pulse-wave at cunkou ie at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph at 10 min after acupuncture.	10 min after acupuncture
Secondary	Range of knee motion	Range of knee motion will be examined by a goniometer.	1) 10 min before acupuncture; 2) within 20 min after needle removal
Secondary	Visual analog scale (VAS)	The intensity of pain is measure using VAS for pain. It is incorporated into the questionnaire with a scale of 0 (no pain) to 10 (worst pain possible)	1) within 40 min before acupuncture; 2) within 20 min after needle removal
Secondary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	A questionnaire developed to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.	within 40 min before acupuncture