Focal Thermal Therapy Acupoint OA Knee RCT

NCT ID: NCT04735029

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-12-31

Brief Summary

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Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

Detailed Description

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Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

A randomized control trial was conducted in 76 patients with osteoarthritis of the knee, diagnosed by an experienced orthopedic surgeon. Following inclusion and exclusion selection, patients were randomly allocated to group 1 (Heat Pack) or group 2 (Thermal Gun). All patients received 30 minutes of treatment in each session, twice a week for 4 weeks. They also received an education program and taught home knee exercises. Outcome measurements were Visual Analog Scale (VAS) for pain intensity, muscle power, knee ROM, WOMAC and SF-12v2.

Conditions

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Osteoarthritis, Knee Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Heat pack group; Group 2: Thermal Gun group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Envelope

Study Groups

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Thermal Gun group

The thermal gun applied on acupressure points in TCM. The thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Group Type EXPERIMENTAL

Thermal gun

Intervention Type DEVICE

Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Heat Pack group

A hydrocollator heat pack used to simulate traditional thermal therapy. The application of the heat pack was wrapped with six layers of terry towels to bring the temperature down to around 43°C.

Group Type ACTIVE_COMPARATOR

Heat pack

Intervention Type OTHER

A hydrocollator heat pack used to simulate traditional thermal therapy

Interventions

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Thermal gun

Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Intervention Type DEVICE

Heat pack

A hydrocollator heat pack used to simulate traditional thermal therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male or female patients aged 40 years old or older
* clinical and radiological diagnosis of osteoarthritis of the knee based on the OA Knee clinical guidelines and radiological evidence
* normal skin sensation to heat, cold, pins and pricks (i.e. passed the required Skin Sensation Test)
* not participating in any other clinical trial at time of this study
* be able to complete the whole trial period
* no cognitive dysfunction and was able to sign the consent form

Exclusion Criteria

* received bilateral knee arthroplasty before this study
* polyarthritis affecting more than both knee
* active skin lesion
* women in pregnancy or breasts feeding
* received acupuncture and/or moxibustion within one month of the study
* unable to comply with the study protocol
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ho Ki Wai

Clinical Professional Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Ki-Wai Ho

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

References

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Ho KK, Kwok AW, Chau WW, Xia SM, Wang YL, Cheng JC. A randomized controlled trial on the effect of focal thermal therapy at acupressure points treating osteoarthritis of the knee. J Orthop Surg Res. 2021 Apr 27;16(1):282. doi: 10.1186/s13018-021-02398-2.

Reference Type DERIVED
PMID: 33906695 (View on PubMed)

Other Identifiers

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2016.555-T

Identifier Type: -

Identifier Source: org_study_id

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