Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Acupuncture; Other: Fumigation

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10844
    • Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Study Chair: CHUNG-HUA HSU, PhD, Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Acupuncture; Knee; Fumigation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Fumigation 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No