Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659370
• Other study ID #: Fumigation 2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Fumigation
use Fumigation to increase the improvement of osteoarthritis of knee
• Acupuncture
Acupuncture

Locations

Country	Name	City	State
Taiwan	Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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