Back to resultsChinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fumigation
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee, Fumigation, Acupuncture
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
Sites / Locations
- Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fumigation Full
Fumigation 1/16
Acupuncture
Arm Description
Full Fumigation after acupuncture, 2 times per week, for 4 weeks.
1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks.
Acupuncture only, 2 times per week, for 4 weeks.
Outcomes
Primary Outcome Measures
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'.
Secondary Outcome Measures
Questionnaire
Record Questionnaire before the study starting and after study finished
Full Information
NCT ID
NCT03659370
First Posted
August 20, 2018
Last Updated
September 6, 2018
Sponsor
Taipei City Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03659370
Brief Title
Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
Official Title
Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Knee, Fumigation, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fumigation Full
Arm Type
Active Comparator
Arm Description
Full Fumigation after acupuncture, 2 times per week, for 4 weeks.
Arm Title
Fumigation 1/16
Arm Type
Active Comparator
Arm Description
1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture only, 2 times per week, for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Fumigation
Intervention Description
use Fumigation to increase the improvement of osteoarthritis of knee
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture
Primary Outcome Measure Information:
Title
Visual Analogue Scale of pain
Description
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'.
Time Frame
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 Measure Information:
Title
Questionnaire
Description
Record Questionnaire before the study starting and after study finished
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHUNG-HUA HSU, PhD
Organizational Affiliation
Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,
Official's Role
Study Chair
Facility Information:
Facility Name
Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
City
Taipei City
ZIP/Postal Code
10844
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
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