Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

NCT03659370 | Completed

• 1 other identifier: Fumigation 2016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee; Fumigation; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Fumigation Full

ACTIVE COMPARATOR

Full Fumigation after acupuncture, 2 times per week, for 4 weeks.

Other: Fumigation

Fumigation 1/16

ACTIVE COMPARATOR

1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks.

Other: Fumigation

Acupuncture

ACTIVE COMPARATOR

Acupuncture only, 2 times per week, for 4 weeks.

Other: Acupuncture

Interventions

Fumigation OTHER

use Fumigation to increase the improvement of osteoarthritis of knee

Fumigation 1/16; Fumigation Full

Acupuncture OTHER

Acupuncture

Acupuncture

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of knee diagnosed by X-ray films
• According Ahlbäck System, more than stage1
• The Visual Analogue Scale of pain over 20mm in 100mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital

Taipei, 10844, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Fumigation; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Complementary Therapies; Therapeutics

Study Officials

• CHUNG-HUA HSU, PhD

  Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 10, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)