Clinical trial NCT04735029: Focal Thermal Therapy Acupoint OA Knee RCT
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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Randomized Controlled Trial
Keywords: knee osteoarthritis
acupuncture
randomized control trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Heat pack group; Group 2: Thermal Gun group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analogue scale (VAS) for pain
timeFrame: Baseline
measure: Visual analogue scale (VAS) for pain
timeFrame: After 1 year
measure: Knee range of movement (ROM)
timeFrame: Baseline
measure: Knee range of movement (ROM)
timeFrame: After 1 year
measure: Quadriceps and hamstrings muscle strength
timeFrame: Baseline
measure: Quadriceps and hamstrings muscle strength
timeFrame: After 1 year
measure: Western Ontario and McMasters Universities (WOMAC)
timeFrame: Baseline
measure: Western Ontario and McMasters Universities (WOMAC)
timeFrame: After 1 year
measure: Short Form-12 version 2 (SF-12v2)
timeFrame: Baseline
measure: Short Form-12 version 2 (SF-12v2)
timeFrame: After 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Kevin Ki-Wai Ho
role: STUDY_DIRECTOR
References:
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.