Focal Thermal Therapy Acupoint OA Knee RCT

Osteoarthritis, Knee Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735029
• Other study ID #: 2016.555-T
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Randomized Controlled Trial

Intervention

Device:
• Thermal gun
Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Other:
• Heat pack
A hydrocollator heat pack used to simulate traditional thermal therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	After 1 year
Primary	Knee range of movement (ROM)	Knee range of movement (ROM) in the supine position using a goniometer; Numeric	Baseline
Primary	Knee range of movement (ROM)	Knee range of movement (ROM) in the supine position using a goniometer; Numeric	After 1 year
Primary	Quadriceps and hamstrings muscle strength	Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric	Baseline
Primary	Quadriceps and hamstrings muscle strength	Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric	After 1 year
Primary	Western Ontario and McMasters Universities (WOMAC)	Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric	Baseline
Primary	Western Ontario and McMasters Universities (WOMAC)	Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric	After 1 year
Primary	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	Baseline
Primary	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	After 1 year