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Completed

NCT Number: NCT03659370

Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital

Taipei, 10844, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fumigation

Other

use Fumigation to increase the improvement of osteoarthritis of knee

Acupuncture

Other

Acupuncture

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 6, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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