Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-11-30
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture group
Subjects in the acupuncture group are given acupuncture treatment.
acupuncture
Subjects in acupuncture group will be received acupuncture treatment by inserting LI11, SJ5, SJ9, SJ13, SJ10, HT3, PC2, LI4, and LI15 on the affected limb and RN12, RN9, RN6, RN4, SP9, SP6. Needles will be remained for 30 minutes each time after DeQi sensation, one time a day，three times a week, the treatment will be lasted for 7 weeks.
Sham acupuncture control group
Subjects in the sham acupuncture control group are given non-acupoint shallow acupuncture.
sham acupuncture
Subjects in control group will be treated with non-acupoint shallow needling, points will be selected 1 cm at the radial direction from acupoint LI11, SJ5, SJ9, SJ13, SJ10, LI4, HT3, PC2, LI4, LI15; 2 cm at the left of acupoint RN12, RN9, RN6, RN4; 1 cm at the tibial direction from SP9, SP6.
The needling manipulation is the same as that of the acupuncture group, but only the superficial skin of points are punctured. The depth of needling is less than 0.5 cm, and no manipulation will be performed after puncturing the skin. Needles will be remained for 30 minutes each time,one time a day，three times a week, the treatment will be lasted for 7 weeks.
Interventions
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acupuncture
Subjects in acupuncture group will be received acupuncture treatment by inserting LI11, SJ5, SJ9, SJ13, SJ10, HT3, PC2, LI4, and LI15 on the affected limb and RN12, RN9, RN6, RN4, SP9, SP6. Needles will be remained for 30 minutes each time after DeQi sensation, one time a day，three times a week, the treatment will be lasted for 7 weeks.
sham acupuncture
Subjects in control group will be treated with non-acupoint shallow needling, points will be selected 1 cm at the radial direction from acupoint LI11, SJ5, SJ9, SJ13, SJ10, LI4, HT3, PC2, LI4, LI15; 2 cm at the left of acupoint RN12, RN9, RN6, RN4; 1 cm at the tibial direction from SP9, SP6.
The needling manipulation is the same as that of the acupuncture group, but only the superficial skin of points are punctured. The depth of needling is less than 0.5 cm, and no manipulation will be performed after puncturing the skin. Needles will be remained for 30 minutes each time,one time a day，three times a week, the treatment will be lasted for 7 weeks.
Eligibility Criteria
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Inclusion Criteria
* Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
* Women aged 18 to 80 years
* Out-patients
* Estimated life expectancy \> 6 months
* Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms
Exclusion Criteria
* Tumor metastasis or recurrent patient
* Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
* Taking diuretic
* Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
* History of primary lymphedema
* A diagnosis of severe heart, liver, kidney or hematologic disease
* Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
* Have hypoproteinemia
* Inflammation, scar, or trauma at the site of operation, or other active skin infections
* Unable to self-care, had a history of psychological disorders, or unable to communicate
* Received lymphedema treatment within the past 1 month
* Pregnancy or breastfeeding
* The presence of electronic medical device implants
* Deny to sign the informed written consent, or unwilling to conform to randomization
* Participation in other clinical trials during the study period
18 Years
80 Years
FEMALE
No
Sponsors
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Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
UNKNOWN
Tianjin Medical University Cancer Institute and Hospital
OTHER
Gansu Provincial Cancer Hospital
UNKNOWN
The Second Affiliated Hospital of Baotou Medical College
OTHER
Tianjin University of Traditional Chinese Medicine
OTHER
Responsible Party
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Yi Guo
The Dean of Traditional Chinese medicine College
Central Contacts
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Other Identifiers
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2014CB543202-03
Identifier Type: -
Identifier Source: org_study_id
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