Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of fumigation in conjunction with acupuncture for knee osteoarthritis, participators were collected from acupuncture and Chinese traumatology clinic at Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital. Participators were randomized into 3 groups, one for acupuncture with fumigation, one for acupuncture with diluted fumigation, one for acupuncture only.

Detailed Description
-----------------
Patient population. Between June 2015 and November 2017, research subjects were recruited via poster display and clinician referral, to participate in a three-armed, randomized, controlled trial to be conducted in the Traumatology Department Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital.

Official Title
-----------------
Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Fumigation
* Other: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of knee diagnosed by X-ray films According Ahlbäck System, more than stage1 The Visual Analogue Scale of pain over 20mm in 100mm Exclusion Criteria: The Visual Analogue Scale of pain less than 20mm in 100mm Received injection or scope treatment over knees Received more than 3 times of operation With severe inflammation (including fever, fluid, pus, gout, Rheumatic arthritis, etc.) With sever systemic diseases (including metastatic cancer, coronary artery disease, lung disease, etc.) With history of skin problem after other thermal treatment Under other experiments Women with pregnant, breastfeeding or prepare for pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fumigation Full<br>Full Fumigation after acupuncture, 2 times per week, for 4 weeks. | Other: Fumigation<br>* use Fumigation to increase the improvement of osteoarthritis of knee<br>|
| Active Comparator: Fumigation 1/16<br>1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks. | Other: Fumigation<br>* use Fumigation to increase the improvement of osteoarthritis of knee<br>|
| Active Comparator: Acupuncture<br>Acupuncture only, 2 times per week, for 4 weeks. | Other: Acupuncture<br>* Acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale of pain | This scale is used to asses change in pain intensity between pre and post intervention measures and change against established baseline measures. Patients are asked to rate their pain by choosing a number along a horizontal line of fixed length (100mm). The number scale ranges from 0-10, with 0 representing 'no pain' and 10 being 'worst pain possible'. | This numeric measure is assed and recorded pre and post intervention at each of the study protocols bi-weekly interventions over (4) weeks, for a maximum of (8) sessions and a total of (16) measurements per individual patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Record Questionnaire before the study starting and after study finished | This questionnaire is administered and recorded after patients have been enrolled in the trial and prior to their first intervention to establish a baseline. At the completion of the protocol's full course of treatment, bi-weekly treatment over (4) weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee, Fumigation, Acupuncture