Focal Thermal Therapy Acupoint OA Knee RCT (ThermAcuRCT)
Primary Purpose
Osteoarthritis, Knee, Randomized Controlled Trial
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal gun
Heat pack
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee osteoarthritis, acupuncture, randomized control trial
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thermal Gun group
Heat Pack group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Knee range of movement (ROM)
Knee range of movement (ROM) in the supine position using a goniometer; Numeric
Knee range of movement (ROM)
Knee range of movement (ROM) in the supine position using a goniometer; Numeric
Quadriceps and hamstrings muscle strength
Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric
Quadriceps and hamstrings muscle strength
Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric
Western Ontario and McMasters Universities (WOMAC)
Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric
Western Ontario and McMasters Universities (WOMAC)
Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04735029
First Posted
January 27, 2021
Last Updated
February 3, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04735029
Brief Title
Focal Thermal Therapy Acupoint OA Knee RCT
Acronym
ThermAcuRCT
Official Title
A Randomized Controlled Trial on the Effect of Focal Thermal Therapy at Acupuncture Points in the Treatment of Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Randomized Controlled Trial
Keywords
knee osteoarthritis, acupuncture, randomized control trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Heat pack group; Group 2: Thermal Gun group
Masking
ParticipantCare Provider
Masking Description
Envelope
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal Gun group
Arm Type
Experimental
Arm Description
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.
Arm Title
Heat Pack group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Thermal gun
Intervention Description
Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.
Intervention Type
Other
Intervention Name(s)
Heat pack
Intervention Description
A hydrocollator heat pack used to simulate traditional thermal therapy
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) for pain
Description
10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.
Time Frame
Baseline
Title
Visual analogue scale (VAS) for pain
Description
10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.
Time Frame
After 1 year
Title
Knee range of movement (ROM)
Description
Knee range of movement (ROM) in the supine position using a goniometer; Numeric
Time Frame
Baseline
Title
Knee range of movement (ROM)
Description
Knee range of movement (ROM) in the supine position using a goniometer; Numeric
Time Frame
After 1 year
Title
Quadriceps and hamstrings muscle strength
Description
Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric
Time Frame
Baseline
Title
Quadriceps and hamstrings muscle strength
Description
Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric
Time Frame
After 1 year
Title
Western Ontario and McMasters Universities (WOMAC)
Description
Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric
Time Frame
Baseline
Title
Western Ontario and McMasters Universities (WOMAC)
Description
Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric
Time Frame
After 1 year
Title
Short Form-12 version 2 (SF-12v2)
Description
Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome
Time Frame
Baseline
Title
Short Form-12 version 2 (SF-12v2)
Description
Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome
Time Frame
After 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ki-Wai Ho
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33906695
Citation
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.
Results Reference
derived
Learn more about this trial
Focal Thermal Therapy Acupoint OA Knee RCT
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