ThermAcuRCT: Focal Thermal Therapy Acupoint OA Knee RCT

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT04735029

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Randomized Controlled Trial	Device: Thermal gun Other: Heat pack	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group 1: Heat pack group; Group 2: Thermal Gun groupGroup 1: Heat pack group; Group 2: Thermal Gun group

Masking:

Double (Participant, Care Provider)

Masking Description:

Envelope

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Ho Ki Wai, Clinical Professional Consultant, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04735029

Other Study ID Numbers:

2016.555-T

First Posted:

Feb 2, 2021

Last Update Posted:

Feb 4, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Ho Ki Wai, Clinical Professional Consultant, Chinese University of Hong Kong

knee osteoarthritis

acupuncture

randomized control trial

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Feb 4, 2021