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

NCT ID: NCT03925467

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2020-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

proximal acupoints

Acupuncture needles will be administered at proximal acupoints

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

distal acupoints

Acupuncture needles will be administered at distal acupoints

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

sham acupoints

Sham acupuncture needles will be administered in the abdominal sham acupoints.

Group Type: PLACEBO_COMPARATOR

Acupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Lee, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Central Contacts

Yu-Chen Lee, M.D.,PhD

Role: CONTACT

d5167@mail.cmuh.org.tw

886-975-682023

Other Identifiers

CMUH108-REC2-033

Identifier Type: -

Identifier Source: org_study_id