Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Fumigation; Other: Acupuncture

• Registration Number: NCT03659370
• Lead Sponsor: Taipei City Hospital

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fumigation Full	Fumigation	Full Fumigation after acupuncture, 2 times per week, for 4 weeks.
Fumigation 1/16	Fumigation	1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks.
Acupuncture	Acupuncture	Acupuncture only, 2 times per week, for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of pain	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.	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

Name	Time	Method
Questionnaire	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	Record Questionnaire before the study starting and after study finished

Trial Locations

Locations (1)

Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital; 🇨🇳 Taipei City, Taiwan