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Clinical Trials/NCT04735029
NCT04735029
Completed
Not Applicable

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

Chinese University of Hong Kong0 sites76 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Chinese University of Hong Kong
Enrollment
76
Primary Endpoint
Short Form-12 version 2 (SF-12v2)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 31, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Ho Ki Wai

Clinical Professional Consultant

Chinese University of Hong Kong

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

Outcomes

Primary Outcomes

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

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

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

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.

Knee range of movement (ROM)

Time Frame: After 1 year

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

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