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

NCT03925467 | Unknown

• 1 other identifier: CMUH108-REC2-033
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; acupuncture; radial pressure pulse-wave; spectral energy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Range of knee motion

  1) 10 min before acupuncture; 2) within 20 min after needle removal

• Visual analog scale (VAS)

  1) within 40 min before acupuncture; 2) within 20 min after needle removal

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  within 40 min before acupuncture

Study Arms (3)

proximal acupoints

EXPERIMENTAL

Acupuncture needles will be administered at proximal acupoints

Other: Acupuncture

distal acupoints

EXPERIMENTAL

Acupuncture needles will be administered at distal acupoints

Other: Acupuncture

sham acupoints

PLACEBO COMPARATOR

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

Other: Acupuncture

Interventions

Acupuncture 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; proximal acupoints; sham acupoints

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yu-Chen Lee, M.D.,PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chen Lee, M.D.,PhD

CONTACT

886-975-682023; d5167@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups, pre-post intervention study

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 24, 2019
• Study Start: April 30, 2019
• Primary Completion: March 24, 2020
• Study Completion: April 1, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04