Focal Thermal Therapy Acupoint OA Knee RCT

Study 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.

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

Conditions
-----------------
Osteoarthritis, Knee, Randomized Controlled Trial

Intervention / Treatment
-----------------
* Device: Thermal gun
* Other: Heat pack


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Heat pack group; Group 2: Thermal Gun group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Gun group<br>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. | Device: Thermal gun<br>* Thermal gun used a heat-generating ceramic head to apply a dual effect called heat-and-light-pressure on the acupuncture points.<br>|
| Active Comparator: Heat Pack group<br>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. | Other: Heat pack<br>* A hydrocollator heat pack used to simulate traditional thermal therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis, acupuncture, randomized control trial