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Acupuncture for Dry Eye Syndrome

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ClinicalTrials.gov Identifier: NCT00969280
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : September 20, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Device: Standardized Acupuncture
Device: Non-acupuncture point shallow penetration acupuncture
Enrollment 42
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 21 21
Completed 19 18
Not Completed 2 3
Reason Not Completed
Protocol Violation             2             1
Withdrawal by Subject             0             1
infection of influenza A(H1N1)             0             1
Arm/Group Title Standardized Acupuncture Group Non-acupoint Shallow Penetration Group Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
21
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
40.52  (11.8) 42.76  (9.59) 41.64  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
16
  76.2%
15
  71.4%
31
  73.8%
Male
5
  23.8%
6
  28.6%
11
  26.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 21 participants 21 participants 42 participants
21 21 42
1.Primary Outcome
Title Ocular Surface Disease Index : OSDI
Hide Description 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.
Time Frame Visit 11 (after 3 weeks from baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Eye symptoms
21 21
Mean (Standard Deviation)
Unit of Measure: Scores on the OSDI score
-17.61  (15.61) -17.20  (18.81)
2.Secondary Outcome
Title Visual Analogue Scale of Self Symptoms
Hide Description [Not Specified]
Time Frame every visit
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Schirmer 1 Test
Hide Description [Not Specified]
Time Frame visit 1,10
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Tear Film Break-up Time : BUT
Hide Description [Not Specified]
Time Frame Visit 1, 10
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Medication Quantification Scale (MQS)
Hide Description [Not Specified]
Time Frame every visit
Outcome Measure Data Not Reported
6.Secondary Outcome
Title General Assessment
Hide Description [Not Specified]
Time Frame visit 11
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standardized Acupuncture Group Non-acupoint Shallow Penetration Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tae-Hun Kim, Researcher
Organization: Korea Institute of Oriental Medicine
Phone: 82-10-6532-5524
EMail: rockandmineral@gmail.com
Layout table for additonal information
Responsible Party: Choi, sun-mi/Principal Investigator, Department of Medical Research, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00969280     History of Changes
Other Study ID Numbers: KI0906
First Submitted: August 31, 2009
First Posted: September 1, 2009
Results First Submitted: September 17, 2010
Results First Posted: September 20, 2010
Last Update Posted: December 21, 2010