Auriculotherapy for Osteoarthritis Knee

NCT02352636 | Completed Phase 3 DMC

• 1 other identifier: G-YBBR
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale of pain (NRS) :

  According to the OMERACT III conference, which was conducted to establish a core set of outcome measures for future OA trials, the perception of pain has the highest preference among the core set of efficacy domains. Therefore, pain perception using NRS is adopted in this study as a primary outcome. The use of NRS is also considered as a good first choice to evaluate pain perception for most older adults because of its established psychometric properties, increased ability to discriminate pain levels, and common use in clinical practice. The NRS could be administered in written or verbal form, and it involves asking the subject to select a number, from 1 to 10 to the nearest 0.5 interval, to represent their maximal OA induced knee pain in the recent 2 to 3 days.

  collected at baseline up to 3 months after therapy

Secondary Outcomes (4)

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

  collected at baseline up to 3 months after therapy

• Standard goniometer

  collected at baseline up to 3 months after therapy

• Timed-up-and-go test (TUGT)

  collected at baseline up to 3 months after therapy

• Subjects' expectations towards therapy

  collected at baseline up to 3 months after therapy

Study Arms (4)

Treatment arm 1

ACTIVE COMPARATOR

Subjects will receive magnetotherapy (MAT). The magnetic pellets will contain an average of \~200 gauss/pellet magnetic flux densities, with a diameter of 1.76 mm. The experimental object will be applied to the reactive region of each of the six selected acupoints as detected by an acupoint detector. The justifications for selecting these acupoints are described below. To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" prior to the application of MAT. Subjects will be asked to wear a pair of laser protective goggles to "blind" them during therapy administration.

Other: magnetotherapy

Treatment arm 2

ACTIVE COMPARATOR

Subjects will receive laser auriculotherapy (LAT). 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 use12, 26. 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. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear. Laser protective goggles will be provided to the subjects and the researchers for eye protection. Similarly, a plaster without magnetic pellets that mimics MAT treatment will be applied on these six acupoints after LAT.

Device: laser auriculotherapy

Treatment arm 3

EXPERIMENTAL

Subjects will receive a combined approach using MAT and LAT. LAT will be administered prior to the application of MAT on the selected auricular points, which would be implemented similar to the procedures in treatment arm 1 and 2.

Other: magnetotherapy; Device: laser auriculotherapy

Placebo arm

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

magnetotherapy OTHER

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

Treatment arm 1; Treatment arm 3

laser auriculotherapy DEVICE

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.

Treatment arm 2; Treatment arm 3

Placebo OTHER

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.

Placebo arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The OA condition will be assessed by physical examination based on the clinical criteria of the American College of Rheumatology criteria. The clinical criteria consisted of pain in the knee and any three of the following:
• aged 50 years of age or over;
• \<=30 minutes of morning stiffness;
• crepitus on active joint motion;
• bony tenderness;
• bony enlargement; or
• no palpable joint warmth.
• This classification has been reported to yield 84% specificity and 89% sensitivity for diagnosis of OA knee.

You may not qualify if:

• other connective tissue diseases affecting the knee;
• knee joint steroid injections within the preceding three months;
• having a hearing aid or pacemaker in situ (this is to avoid possible interaction between the pacemaker and the magnetic pellets);
• receiving AT within the preceding three months;
• suffering from aural injuries or infections; and
• inability to understand instructions or give consent.
• The assessment is conducted by a research assistant who will receive intensive coaching on the physical assessment and therapy administration by the research team. Potential subjects will be further assessed by a registered medical practitioner who has over 15 years of clinical experience when the assessment on the OA condition by the RA and the research team is in doubt.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

Sai Kung District Community Centre

Hong Kong, Hong Kong, 00000, Hong Kong

Location

The Neighbourhood Advice-Action Council

Hong Kong, Hong Kong, 00000, Hong Kong

Location

Related Publications (1)

• Suen LK, Yeh CH, Yeung SK. Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study. BMC Complement Altern Med. 2016 Jul 29;16:257. doi: 10.1186/s12906-016-1242-6.

  PMID: 27473749 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lorna Suen, MPH, PhD

  School of Nursing, The Hong Kong Polytechnic University, Hong Kong.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

HK (2)