Condition category
Musculoskeletal Diseases
Date applied
13/04/2017
Date assigned
03/05/2017
Last edited
10/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Hui Yang

ORCID ID

http://orcid.org/0000-0001-7796-4869

Contact details

Zhejiang University of Chinese Medicine
548 Binwen Road
Hangzhou
Zhejiang
Hangzhou
310053
China
+86 180 697 52299
zcmuclinic@zcmu.edu.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013zjtcm-031

Study information

Scientific title

The auxiliary diagnostic value of fissured tongue on axial and peripheral joint dysfunction in Ankylosing Spondylitis

Acronym

Study hypothesis

This study is aim to identity whether fissured tongue (FT) has auxiliary diagnostic value in ankylosing spondylitis (AS).

Ethics approval

Zhejiang Chinese Medicine University ethics review board, 01/03/2013, ref: no.2013zjtcm-031

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

06/01/2013

Overall trial end date

09/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 15 to 67 years old
2. Diagnosed with AS (fulfill the modified New York criteria for ankylosing spondylitis)

Participant type

Patient

Age group

Adult

Gender

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.

Participant exclusion criteria

1. Obvious fissured tongue existing from childhood
2. Diagnosis of traumatic fissured tongue
3. Reluctance to take tongue photographs

Recruitment start date

08/01/2013

Recruitment end date

04/01/2014

Locations

Countries of recruitment

China

Trial participating centre

Zhejiang University Of Chinese Medicine
Laboratory Of Immunologic & Rheumatology
Hangzhou
310053
China

Trial participating centre

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

Trial participating centre

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

Sponsor information

Organisation

Zhejiang University Of Chinese Medicine

Sponsor details

548 Binwen Road
Hangzhou
Zhejiang
Hangzhou
310053
China
+86 866 13587
zcmuclinic@zcmu.edu.cn

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Natural Science Foundation of Zhejiang Province

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Public Welfare Industry

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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

Intention to publish date

06/01/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/08/2017: Internal review.