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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee osteoarthritis, acupuncture, randomized control trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    January 27, 2021
    Last Updated
    February 3, 2021
    Sponsor
    Chinese University of Hong Kong
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    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

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    Focal Thermal Therapy Acupoint OA Knee RCT

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