The auxiliary diagnostic value of fissured tongue in Ankylosing Spondylitis
| ISRCTN | ISRCTN23541842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23541842 |
| Secondary identifying numbers | 2013zjtcm-031 |
- Submission date
- 13/04/2017
- Registration date
- 03/05/2017
- Last edited
- 10/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Ankylosing spondylitis (AS) is a long-term disease that causes inflammation (swelling) in the spine and other areas of the body. Symptoms include back pain, stiffness, swelling and tiredness. There is usually a delay in diagnosing AS as the symptoms are usually thought to be caused by general back pain. Fissured tongues (FT) are a condition where the surface of the tongue has deep grooves. In Traditional Chinese Medicine (TCM), fissured tongues are shown to have an impact on the auxiliary (additional) diagnostic value in AS. Other studies have shown that FT is more common in people with disease than in healthy individuals, for example people with psoriasis have an increased rate of FT. Other immune diseases have similar symptoms. The aim of this study is to identify whether fissured tongue (FT) has an auxiliary diagnostic value in ankylosing spondylitis (AS).
Who can participate?
Adults aged 15 to 67 years old who are diagnosed with ankylosing spondylitis.
What does the study involve?
Participants are allocated to one of two groups based on if they have a fissured tongue or not. All participants undergo three study visits spaced 12 weeks apart. They are assessed for their level of fissured tongue and their pain levels. Also, blood samples are taken to test specific markers and levels found in the blood. They also have scans taken of their spine. The results for each group are compared to see if fissured tongues have a diagnostic value in AS.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
This study is being run by the Zhejiang University of Chinese Medicine (China) and takes place in two affiliated hospitals (China).
When is the study starting and how long is it expected to run for?
January 2013 to January 2015
Who is funding the study?
1. National Natural Science Foundation of Zhejiang Province (China)
2. National Public Welfare Industry (China)
Who is the main contact?
Dr Hui Yang
zcmuclinic@zcmu.edu.cn
Contact information
Public
Zhejiang University of Chinese Medicine
548 Binwen Road
Hangzhou
Zhejiang
Hangzhou
310053
China
 ORCID ID |
0000-0001-7796-4869 |
|---|---|
| Phone | +86 180 697 52299 |
| zcmuclinic@zcmu.edu.cn |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The auxiliary diagnostic value of fissured tongue on axial and peripheral joint dysfunction in Ankylosing Spondylitis |
| Study objectives | This study is aim to identity whether fissured tongue (FT) has auxiliary diagnostic value in ankylosing spondylitis (AS). |
| Ethics approval(s) | Zhejiang Chinese Medicine University ethics review board, 01/03/2013, ref: no.2013zjtcm-031 |
| Health condition(s) or problem(s) studied | Ankylosing spondylitis |
| Intervention | Participants are screened and undergo a clinical examination and medical history. All participants are screened for pre-existing disease, such as hypertension, dyslipidemia, diabetes mellitus, and inflammatory bowel disease. Information on the use of medications, including meloxicam, salazosulfapyridine, methotrexatep, folic acid, etanercept, thalidomide, celebrex, and methylprednisolone is retrieved from the medical records. Participants are divided to one of two groups based on if they have a fissured tongue or not. Fissured tongue group (FT): Participants this in group are assessed at baseline, week 12 and week 24 (for follow up). Participants are assessed for their fissured tongue level. Participants have their pain levels assessed using the axial joint pain (AJP) and peripheral joint pain (PJP) levels scale and the visual analog scale (VAS). Participants also complete a morning stiff sale (SMS) that categorically lists the duration of morning stiffness as no stiffness. The axial and peripheral arthritis levels are assessed by physicians. Participants also undergo a physical examination and have a blood test to evaluate the complete blood cell count and measurement of blood levels of glucose, creatinine, electrolytes, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, lipoprotein(a), antistreptolysin O (ASO), erythrocyte sedimentation rate(ESR), and C-reactive protein (CRP). Disease activity was evaluated with the erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Middle-finger-to-floor distance and occiput-to-wall distance was used to evaluate spinal flexibility. Plain radiographs of the axial and peripheral were obtained from participants to determine the progress of axial and peripheral arthritis. Non-fissue tongue group (NFT): Participants undergo the same testing as the fissured tongue group. The results from each group are compared to see if fissured tongues have an auxiliary diagnostic value in AS. |
| Intervention type | Other |
| Primary outcome measure | 1. Fissured tongue level is measured using photographs and computer programs at baseline, and week 24 2. Axial joint paint is measured using the visual analog scale, stiff morning time scale (SMS) and physical examinations at baseline, week 12 and week 24 3. Peripheral joint pain level is measured using the visual analog scale, stiff morning time scale (SMS) and physical examination at baseline, week 12 and week 24 4. HLA-B27 is measured using flow cytometry at baseline, week 12 and week 24 5. C-reactive protein level is measured using clinical samples at baseline, week 12 and week 24 6. Radiographic damage is measured using radiography at baseline, week 12 and week 24 |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 06/01/2013 |
| Completion date | 09/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total of 119 patients (33.3±10.6 years old) were recruited with a median symptom duration of 6.0 years. |
| Key inclusion criteria | 1. Adults aged 15 to 67 years old 2. Diagnosed with AS (fulfill the modified New York criteria for ankylosing spondylitis) |
| Key exclusion criteria | 1. Obvious fissured tongue existing from childhood 2. Diagnosis of traumatic fissured tongue 3. Reluctance to take tongue photographs |
| Date of first enrolment | 08/01/2013 |
| Date of final enrolment | 04/01/2014 |
Locations
Countries of recruitment
- China
Study participating centres
Hangzhou
310053
China
The First Affiliated Hospital Of Zhongshan University
Guangzhou
510080
China
Hangzhou
310053
China
Sponsor information
University/education
548 Binwen Road
Hangzhou
Zhejiang
Hangzhou
310053
China
| Phone | +86 866 13587 |
|---|---|
| zcmuclinic@zcmu.edu.cn | |
"ROR" |
https://ror.org/04epb4p87 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 06/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from zcmuclinic@zcmu.edu.cn |
Editorial Notes
10/08/2017: Internal review.
