Focal Thermal Therapy Acupoint OA Knee RCT (ThermAcuRCT)

A Randomized Controlled Trial on the Effect of Focal Thermal Therapy at Acupuncture Points in the Treatment of Osteoarthritis of the Knee

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Randomized Controlled Trial
• Intervention / Treatment: Device: Thermal gun; Other: Heat pack

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Thermal gun; Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.
Active Comparator: 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.	Other: Heat pack; A hydrocollator heat pack used to simulate traditional thermal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) for pain	10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.	Baseline
Visual analogue scale (VAS) for pain	10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.	After 1 year
Knee range of movement (ROM)	Knee range of movement (ROM) in the supine position using a goniometer; Numeric	Baseline
Knee range of movement (ROM)	Knee range of movement (ROM) in the supine position using a goniometer; Numeric	After 1 year
Quadriceps and hamstrings muscle strength	Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric	Baseline
Quadriceps and hamstrings muscle strength	Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric	After 1 year
Western Ontario and McMasters Universities (WOMAC)	Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric	Baseline
Western Ontario and McMasters Universities (WOMAC)	Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric	After 1 year
Short Form-12 version 2 (SF-12v2)	Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome	Baseline
Short Form-12 version 2 (SF-12v2)	Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome	After 1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Director: Kevin Ki-Wai Ho, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: knee osteoarthritis; acupuncture; randomized control trial
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2016.555-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No