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Completed

NCT Number: NCT04735029

Focal Thermal Therapy Acupoint OA Knee RCT

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Randomized Controlled Trial Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal gun

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

Other

A hydrocollator heat pack used to simulate traditional thermal therapy

Primary outcomes

  1. Visual analogue scale (VAS) for pain

    Time frame: Baseline

    10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.

  2. Visual analogue scale (VAS) for pain

    Time frame: 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.

  3. Knee range of movement (ROM)

    Time frame: Baseline

    Knee range of movement (ROM) in the supine position using a goniometer; Numeric

  4. Knee range of movement (ROM)

    Time frame: After 1 year

    Knee range of movement (ROM) in the supine position using a goniometer; Numeric

  5. Quadriceps and hamstrings muscle strength

    Time frame: Baseline

    Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric

  6. Quadriceps and hamstrings muscle strength

    Time frame: After 1 year

    Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric

  7. Western Ontario and McMasters Universities (WOMAC)

    Time frame: Baseline

    Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric

  8. Western Ontario and McMasters Universities (WOMAC)

    Time frame: After 1 year

    Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric

  9. Short Form-12 version 2 (SF-12v2)

    Time frame: Baseline

    Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome

  10. Short Form-12 version 2 (SF-12v2)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: ThermAcuRCT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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