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ObesityPhase 2NCT01102075

The Effect of Electroacupuncture on Obesity

A Phase 2 study testing Electroacupuncture in people with Obesity, run by Kyunghee University Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Obesity
What is being tested?
Electroacupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteSouth Korea
Study dates
Jan 2010to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Waist circumference: Male>= 90 cm, Female >= 85 cm
  • BMI over than 25kg/m2

Who cannot join

  • Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc.
  • Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
  • Hypertension, hyperlipidemia or hypercholesterinemia patients on medication
  • Stroke or otherwise unable to exercise
  • Pregnant or lactating women
  • Childbirth within 6 months
  • Management for weight control within 3 months
  • Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyunghee University Medical Center

    Seoul, Hoegi-dong, Dongdaemun-gu, 130-702

Other trials in South Korea

About this study

Official title: The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study

The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

Read the detailed description

Many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(Wang F. et al. 2008)Recently conducted systematic review of Pittler and Ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. However, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. In this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.

Conditions
Obesity
Being tested
Electroacupuncture, Sham electroacupuncture procedure
Keywords
Obesity, Electroacupuncture, Sham electroacupuncture, Waist circumference, Thickness of subcutaneous fat
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectroacupunctureDevice

    Also called EA group

    We used Electrical stimulator(STN-111,Stratek)with a frequency of 24 Hz and intensity of 0.27-1.3mA(tolerable strength), asymmetric interactive pulse with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks(10 sessions) by practitioner.(n=13)

  • Sham electroacupuncture procedureDevice

    Also called Sham EA group

    We used same electroacupuncture device, number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment. Specific details are as described in the arm description.(n=13)

Study groups in NCT01102075
Study groupRoleWhat they receive
ElectroacupunctureExperimentalThe Electroacupuncture therapy protocol included a total of 12 acupuncture points at the CV12,CV6, bilateral ST25, SP15, SP14,LI4, LI11, ST36, ST44. All acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Abdominal acupuncture points were inserted horizontally 6~6.5cm in depth and the others were inserted vertically 2~2.5cm in depth until patient can feel De-Qi. All acupuncture points were stimulated electrically with a frequency of 24 Hz an intensity of 0.27-1.3mA(tolerable strength) with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks by practitioner who had had 6 years of acupuncture training and 3 more years of clinical experience.
Receives: Device: Electroacupuncture
Sham electroacupuncture procedureSham comparatorThe Sham electroacupuncture therapy protocol(Non-acupoint, No electrical stimulation)included the same number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment, but superficially at non acupuncture points 15 mm to the lateral of each acupuncture point was treated. The points were not stimulated electrically, but the sound of the pulse generator was heard by the participants. (Lee SH, LeeBC 2009) Those receiving EA or SEA therapy were treated on alternate days to prevent crosstalk among groups, which could have compromised the blinded study design.
Receives: Device: Sham electroacupuncture procedure
Waiting listNo interventionNo treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. waist circumference

    Measured: At 5 weeks (post treatment)

Secondary outcomes (34)

  1. Thickness of abdominal subcutaneous fat

    Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).

    Measured: Study Day 1 (Baseline)

  2. Thickness of abdominal subcutaneous fat

    Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).

    Measured: At 3weeks

  3. Thickness of abdominal subcutaneous fat

    Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).

    Measured: At 5weeks (post treatment)

  4. Thickness of abdominal subcutaneous fat

    Thickness of abdominal subcutaneous fat was measured by digital skinfold caliper(FatTrack).

    Measured: At 8weeks after first treatment (follow up)

  5. Waist hip ratio

    Measured: Study Day 1 (Baseline)

  6. Waist hip ratio

    Measured: At 3weeks

  7. Waist hip ratio

    Measured: At 5weeks (post treatment)

  8. Waist hip ratio

    Measured: At 8weeks after first treatment (follow up)

  9. Body Mass Index

    Body Mass Index was measured by Inbody 720

    Measured: Study Day 1 (Baseline)

  10. Body Mass Index

    Body Mass Index was measured by Inbody 720

    Measured: At 3weeks

  11. Body Mass Index

    Body Mass Index was measured by Inbody 720

    Measured: At 5weeks (post treatment)

  12. Body Mass Index

    Body Mass Index was measured by Inbody 720

    Measured: At 8weeks after first treatment (follow up)

  13. Body fat ratio

    Body fat ratio was measured by Inbody 720

    Measured: Study Day 1 (Baseline)

  14. Body fat ratio

    Body fat ratio was measured by Inbody 720

    Measured: At 3weeks

  15. Body fat ratio

    Body fat ratio was measured by Inbody 720

    Measured: At 5weeks (post treatment)

  16. Body fat ratio

    Body fat ratio was measured by Inbody 720

    Measured: At 8weeks after first treatment (follow up)

  17. Visceral Fat Area

    Visceral Fat Area was measured by Inbody 720

    Measured: Study Day 1 (Baseline)

  18. Visceral Fat Area

    Visceral Fat Area was measured by Inbody 720

    Measured: At 3weeks

  19. Visceral Fat Area

    Visceral Fat Area was measured by Inbody 720

    Measured: At 5weeks (post treatment)

  20. Visceral Fat Area

    Visceral Fat Area was measured by Inbody 720

    Measured: At 8weeks after first treatment (follow up)

  21. Body weight

    Body weight was measured by Inbody 720

    Measured: Study Day 1 (Baseline)

  22. Body weight

    Body weight was measured by Inbody 720

    Measured: At 3weeks

  23. Body weight

    Body weight was measured by Inbody 720

    Measured: At 5weeks (post treatment)

  24. Body weight

    Body weight was measured by Inbody 720

    Measured: At 8weeks after first treatment (follow up)

  25. Obesity degree

    Obesity degree was measured by Inbody 720

    Measured: Study Day 1 (Baseline)

  26. Obesity degree

    Obesity degree was measured by Inbody 720

    Measured: At 3weeks

  27. Obesity degree

    Obesity degree was measured by Inbody 720

    Measured: At 5weeks (post treatment)

  28. Obesity degree

    Obesity degree was measured by Inbody 720

    Measured: At 8weeks after first treatment (follow up)

  29. Bulimia Test Revised

    Measured: Study Day 1 (Baseline)

  30. Bulimia Test Revised

    Measured: At 5weeks (post treatment)

  31. Korean version of Obesity-related QOL scale

    Measured: Study Day 1 (Baseline)

  32. Korean version of Obesity-related QOL scale

    Measured: At 5weeks (post treatment)

  33. Body Shape Questionnaire

    Measured: Study Day 1 (Baseline)

  34. Body Shape Questionnaire

    Measured: At 5weeks (post treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2010 (estimated)
  4. Study completionMay 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01102075
Sponsor's protocol ID
KOMC MIRB 2009-6
Status last verified
Sep 2009
First submitted
6 Apr 2010
Last updated
12 Apr 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee SH, Lee BC. Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology. 2009 May;73(5):1036-41. doi: 10.1016/j.urology.2008.10.047.

    PubMed 19394499

  • Wang F, Tian DR, Han JS. Electroacupuncture in the treatment of obesity. Neurochem Res. 2008 Oct;33(10):2023-7. doi: 10.1007/s11064-008-9822-6. Epub 2008 Aug 22.

    PubMed 18719995

  • Pittler MH, Ernst E. Complementary therapies for reducing body weight: a systematic review. Int J Obes (Lond). 2005 Sep;29(9):1030-8. doi: 10.1038/sj.ijo.0803008.

    PubMed 15925954

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Electroacupuncture in people with Obesity, run by Kyunghee University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

waist circumference (time frame: At 5 weeks (post treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102075, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2010.

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