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Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03659370
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Fumigation Other: Acupuncture Not Applicable

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  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Visual Analogue Scale of pain [ 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. ]
    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 :
  1. Questionnaire [ 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 ]
    Record Questionnaire before the study starting and after study finished



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659370


Locations
Taiwan
Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Taipei City, Taiwan, 10844
Sponsors and Collaborators
Taipei City Hospital
Investigators
Study Chair: CHUNG-HUA HSU, PhD Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,

Responsible Party: Taipei City Hospital
ClinicalTrials.gov Identifier: NCT03659370     History of Changes
Other Study ID Numbers: Fumigation 2016
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei City Hospital:
Osteoarthritis
Knee
Fumigation
Acupuncture

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases