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

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ClinicalTrials.gov Identifier: NCT03925467
Recruitment Status : Unknown
Verified April 2019 by China Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Acupuncture Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three groups, pre-post intervention study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Immediate Effects of Proximal and Distal Acupoints on the Radial Pressure Pulse-wave in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : March 24, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: proximal acupoints
Acupuncture needles will be administered at proximal acupoints
 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.
Experimental: distal acupoints
Acupuncture needles will be administered at distal acupoints
 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.
Placebo Comparator: sham acupoints
Sham acupuncture needles will be administered in the abdominal sham acupoints.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of Radial Pressure Pulse-wave at cunkou (1) [ Time Frame: 20 min before acupuncture ]
    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.

  2. Assessment of Radial Pressure Pulse-wave at cunkou (2) [ Time Frame: 10 min after acupuncture ]
    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.


Secondary Outcome Measures :
  1. Range of knee motion [ Time Frame: 1) 10 min before acupuncture; 2) within 20 min after needle removal ]
    Range of knee motion will be examined by a goniometer.

  2. Visual analog scale (VAS) [ Time Frame: 1) within 40 min before acupuncture; 2) within 20 min after needle removal ]
    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)

  3. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: within 40 min before acupuncture ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925467


Contacts
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Contact: Yu-Chen Lee, M.D.,PhD 886-975-682023 d5167@mail.cmuh.org.tw

Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Yu-Chen Lee, M.D.,PhD China Medical University Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03925467    
Other Study ID Numbers: CMUH108-REC2-033
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
knee osteoarthritis
acupuncture
radial pressure pulse-wave
spectral energy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases