The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery
NCT ID: NCT04608175
Last Updated: 2020-10-29
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
40 participants
INTERVENTIONAL
2020-11-30
2023-03-31
Brief Summary
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Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications.
Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acupuncture group
The experimental group will receive the standard treatment administered in these cases (analgesic regimen and nursing care procedures), in addition to the following acupuncture therapy.
In the first visit (preoperative), the anamnesis and energy diagnosis of each patient will be carried out following the practices of Traditional Chinese Medicine (TCM) to design a personalized treatment based on the patient's medical history. A treatment of approximately 10 to 12 acupuncture points will be designed considering the TCM diagnosis and medical history of each patient. Both TCM diagnosis and the points used will be reassessed in each session. The points belonging to the upper extremity of the affected breast will be treated on the contralateral side, taking care not to insert any needle in the limb on the affected side. No points in the operated region will be used.
Acupuncture
Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
Control group
The control group will only receive standard care procedures (analgesic regimen and nursing care procedures), although they will have the same follow up visits as the patients in the intervention group to facilitate analysis of the study variables.
No interventions assigned to this group
Interventions
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Acupuncture
Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
Eligibility Criteria
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Inclusion Criteria
* Primary breast cancer patient
* Candidate for breast cancer surgery (mastectomy)
* Aged between 20 and 70 years old
* Consenting to participate in the study and signing the informed consent form.
Exclusion Criteria
* Have a previous diagnosis of a severe psychiatric disorder
* Present risk factors associated with breast cancer
* Do not speak Spanish or Catalan
* Are currently participating in another trial.
20 Years
70 Years
FEMALE
No
Sponsors
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Hospital Quiron Sagrado Corazon
OTHER
University Ramon Llull
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2019/59-FIS-HUSC
Identifier Type: OTHER
Identifier Source: secondary_id
001
Identifier Type: -
Identifier Source: org_study_id