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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COMPLETED
NA
108 participants
INTERVENTIONAL
2018-01-18
2020-12-26
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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local distribution points association
Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.
local distribution points association
Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.
local-distal points association
Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.
local-distal points association
Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.
waiting-list
Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed.
No interventions assigned to this group
Interventions
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local distribution points association
Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.
local-distal points association
Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.
Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.
Eligibility Criteria
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Inclusion Criteria
* Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
* Karnofsky Performance Score (KPS) ≥ 70
* Men or women aged 18 to 80 years
* Out-patients
* Estimated life expectancy \> 6 months
Exclusion Criteria
* Taking diuretic
* 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
ALL
No
Sponsors
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National Basic Research Program, China
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
The Second Affiliated Hospital of Baotou Medical College
OTHER
Henan Provincial People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Tianjin University of Traditional Chinese Medicine
OTHER
Responsible Party
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Yi Guo
The Dean of Acupuncture and Moxibustion College
Principal Investigators
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XingFang Pan
Role: PRINCIPAL_INVESTIGATOR
Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Locations
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Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Countries
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References
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Yeh CH, Zhao TY, Zhao MD, Wu Y, Guo YM, Pan ZY, Dong RW, Chen B, Wang B, Wen JR, Li D, Guo Y, Pan XF. Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2019 Jul 5;20(1):403. doi: 10.1186/s13063-019-3491-4.
Other Identifiers
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2014CB543202-02
Identifier Type: -
Identifier Source: org_study_id
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