Auriculotherapy for Osteoarthritis Knee

NCT02352636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-08-16

No results posted yet for this study

Summary

Osteoarthritis (OA) is the most common form of arthritis in Hong Kong and a prevalent condition in the ageing population. With disease progression, some clients may develop severe pain and profound limitations in ambulation, which may result in morbidity and impaired physical functions. Among the available treatments, pharmacological therapies primarily focus on musculoskeletal pain relief. However, adverse effects, such as gastrointestinal haemorrhage arising from non-steroidal anti-inflammatory drugs have led to an increasing number of concerns regarding the use of these treatments. Other non-invasive complementary methods for osteoarthritic knee (OA knee) should be explored because of the limitations of pharmacological therapy.

Auriculotherapy (AT) is one of the approaches in traditional Chinese medicine (TCM). It is a therapeutic method by which specific points on the auricle are stimulated to treat various disorders of the body. The present study is a four-arm randomised controlled study to determine the effectiveness of AT using magneto-AT (MAT) and/or laser AT (LAT) to improve the conditions of elderly patients suffering from OA knee. The effectiveness of MAT and LAT in terms of alleviating pain, relieving stiffness and promoting a range of motion, and enhancing functional abilities will be determined.

Subjects in 'Treatment arm 1' will receive MAT on specific auricular points on one side of the ear during each treatment session. A deactivated laser will be used to achieve the effect of subject blinding. Subjects in 'Treatment arm 2' will receive LAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LAT). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to have an effect on the OA knee will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study could advance the knowledge on the complementary approaches than can be used to improve OA knee conditions in the elderly.

Conditions

Interventions

OTHER

magnetotherapy

The magnetic pellets will contain an average of \~200 gauss/pellet magnetic flux densities, with a diameter of 1.76 mm

DEVICE

laser auriculotherapy

A laser device (pointer pulse) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. This application belongs to a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer.

OTHER

Placebo

Subjects will serve as a placebo control, and will receive LAT at "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of plaster without magnetic pellets that mimic MAT treatment.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Lorna Suen, MPH, PhD · School of Nursing, The Hong Kong Polytechnic University, Hong Kong.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352636 on ClinicalTrials.gov