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This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Acupuncture group | Experimental |
| |
| Non-acupoint shallow penetration group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Acupuncture | Device | Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks. According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle. All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index : OSDI | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline. | Visit 11 (after 3 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale of Self Symptoms | every visit | |
| Schirmer 1 Test | visit 1,10 | |
| Tear Film Break-up Time : BUT |
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Inclusion Criteria:
Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunmi Choi, doctor | Korea Institute of Oriental Medicine | Study Director |
| Taehun Kim, Doctor | Korea Institute of Oriental Medicine | Principal Investigator |
| Mi-suk Shin, Master | Korea Institute of Oriental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Korea institute of oriental medicine | Daejeon | Chongchungdo | 302-869 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19958541 | Derived | Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, Jung SY, Kim AR, Seol JU, Choi SM. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009 Dec 3;10:112. doi: 10.1186/1745-6215-10-112. |
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49 participants were tested for eligibility. 6 were excluded because of the insufficient pre-allocation test, denied informed consent and other reasons. After 1 week run-in period, 1 participant was excluded for withdrawal of informed consent. After all, 42 participants were included in this trial.
Recruitment period was from 15 September 2009 to 27 October 2009. Through the advertisements in regional newspapers or university websites, patients were recruited at the clinical research center of the Korea Institute of Oriental Medicine (KIOM) in Daejeon University hospital, Daejeon, Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standardized Acupuncture Group | Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after "de qi" manipulation for the verum acupuncture group. |
| FG001 | Non-acupoint Shallow Penetration Group | 17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standardized Acupuncture Group | Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after "de qi" manipulation for the verum acupuncture group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Surface Disease Index : OSDI | The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline. | Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants. | Posted | Mean | Standard Deviation | Scores on the OSDI score | Visit 11 (after 3 weeks from baseline) | Eye symptoms | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standardized Acupuncture Group | Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after "de qi" manipulation for the verum acupuncture group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tae-Hun Kim, Researcher | Korea Institute of Oriental Medicine | 82-10-6532-5524 | rockandmineral@gmail.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| Non-acupuncture point shallow penetration acupuncture | Device | Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks. Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes. |
|
| Visit 1, 10 |
| Medication Quantification Scale (MQS) | every visit |
| General Assessment | visit 11 |
| infection of influenza A(H1N1) |
|
| BG001 | Non-acupoint Shallow Penetration Group | 17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standardized Acupuncture Group |
Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after "de qi" manipulation for the verum acupuncture group. |
| OG001 | Non-acupoint Shallow Penetration Group | 17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints. |
|
|
| Secondary | Visual Analogue Scale of Self Symptoms | Not Posted | every visit |
| Secondary | Schirmer 1 Test | Not Posted | visit 1,10 |
| Secondary | Tear Film Break-up Time : BUT | Not Posted | Visit 1, 10 |
| Secondary | Medication Quantification Scale (MQS) | Not Posted | every visit |
| Secondary | General Assessment | Not Posted | visit 11 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Non-acupoint Shallow Penetration Group | 17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints. | 0 | 21 | 0 | 21 |
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