OsteoarthritisNCT03659370
Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
A study testing Fumigation and Acupuncture in people with Osteoarthritis, run by Taipei City Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fumigation and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of knee diagnosed by X-ray films
- According Ahlbäck System, more than stage1
- The Visual Analogue Scale of pain over 20mm in 100mm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Taipei, 10844
About this study
Official title: Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Fumigation, Acupuncture
- Keywords
- Osteoarthritis, Knee, Fumigation, Acupuncture
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FumigationOther
use Fumigation to increase the improvement of osteoarthritis of knee
AcupunctureOther
Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Fumigation Full | Active comparator | Full Fumigation after acupuncture, 2 times per week, for 4 weeks. Receives: Other: Fumigation |
| Fumigation 1/16 | Active comparator | 1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks. Receives: Other: Fumigation |
| Acupuncture | Active comparator | Acupuncture only, 2 times per week, for 4 weeks. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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
Record Questionnaire before the study starting and after study finished
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- CHUNG-HUA HSU, PhD, Study chair, Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659370
- Sponsor's protocol ID
- Fumigation 2016
- Status last verified
- Jun 2018
- First submitted
- 20 Aug 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03659370
- Acronym / sponsor ID
- Fumigation 2016
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Fumigation, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fumigation Full | Active comparator | Other: FumigationFull Fumigation after acupuncture, 2 times per week, for 4 weeks. |
| Fumigation 1/16 | Active comparator | Other: Fumigation1/16 Fumigation after acupuncture, 2 times per week, for 4 weeks. |
| Acupuncture | Active comparator | Other: AcupunctureAcupuncture only, 2 times per week, for 4 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis of knee diagnosed by X-ray films
- According Ahlbäck System, more than stage1
- The Visual Analogue Scale of pain over 20mm in 100mm
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fumigationuse Fumigation to increase the improvement of osteoarthritis of knee | Other | Fumigation 1/16, Fumigation Full |
| AcupunctureAcupuncture | Other | Acupuncture |
Primary outcome
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'.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHUNG-HUA HSU, PhD study chair
Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fumigation and Acupuncture in people with Osteoarthritis, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.