The auxiliary diagnostic value of fissured tongue in Ankylosing Spondylitis

ISRCTN	ISRCTN23541842
DOI	https://doi.org/10.1186/ISRCTN23541842
Protocol serial number	2013zjtcm-031
Sponsor	Zhejiang University Of Chinese Medicine
Funders	National Natural Science Foundation of Zhejiang Province, National Public Welfare Industry

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Hui Yang
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
Email	zcmuclinic@zcmu.edu.cn

Study information

Primary study design	Observational
Study design	Observational cohort study
Secondary study design	Cohort study
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	There are no secondary outcome measures.
Completion date	09/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	119
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

Zhejiang University Of Chinese Medicine

Laboratory Of Immunologic & Rheumatology
Hangzhou
310053
China

The First Affiliated Hospital of Zhongshan University

Zhejiang University Of Chinese Medicine
The First Affiliated Hospital Of Zhongshan University
Guangzhou
510080
China

The Second Affiliated Hospital Of Zhejiang University Of Medicine

The Second Affiliated Hospital Of Zhejiang University Of Medicine
Hangzhou
310053
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/08/2017: Internal review.