Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema
NCT ID: NCT07072780
Last Updated: 2025-07-18
Study Results
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Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2023-11-23
2024-12-31
Brief Summary
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Detailed Description
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Each participant will receive ten treatment sessions. Every session will consist of 60 minutes of conventional complex decongestive physiotherapy (CDPT), including manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression, followed by 20 minutes of laser therapy. All participants will receive fluoroscopy-guided manual lymphatic drainage during each session.
The 904 nm wavelength laser (LTU-904, RianCorp) and the 650 nm laser (Salus Talent, Remed) will deliver the same energy dose (22.5 J/cm²) during treatment. The sham group will receive placebo treatment with no active laser emission. Laser therapy will be applied to the most fibrotic area of the affected upper limb in a circular area approximately 7 cm in diameter. The irradiation will be performed point-by-point with 1 cm intervals. Five-minute rest intervals will be given between treatments.
Randomization will be conducted using stratified block randomization (block size of 4), and allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Participants will be blinded to the wavelength used. Outcome assessors will also be blinded to group allocation.
The primary outcome is change in upper limb volume. Secondary outcomes include changes in extracellular fluid ratio, tissue dielectric constant, circumferential measurements. Pre- and post-intervention assessments will be conducted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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904nm LLLT (LTU-904)
Participants will receive low-level laser therapy using the LTU-904 device at a wavelength of 904 nm after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.
Low-Level Laser Therapy (650 nm)
Low-level laser therapy using the Salus Talent device (Remed, USA) at a wavelength of 650 nm, applied to the fibrotic area of the upper limb after CDPT.
Sham Laser Therapy
Placebo laser therapy with no active laser emission, administered after CDPT.
650 nm LLLT (Salus Talent)
Participants will receive low-level laser therapy using the Salus Talent device at a wavelength of 650 nm after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.
Low-Level Laser Therapy (904 nm)
Low-level laser therapy using the LTU-904 device (RianCorp, Australia) at a wavelength of 904 nm, applied to the fibrotic area of the upper limb after CDPT.
Sham Laser Therapy
Placebo laser therapy with no active laser emission, administered after CDPT.
Sham Laser Therapy
Participants will receive sham laser therapy with no active laser emission after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.
Low-Level Laser Therapy (904 nm)
Low-level laser therapy using the LTU-904 device (RianCorp, Australia) at a wavelength of 904 nm, applied to the fibrotic area of the upper limb after CDPT.
Low-Level Laser Therapy (650 nm)
Low-level laser therapy using the Salus Talent device (Remed, USA) at a wavelength of 650 nm, applied to the fibrotic area of the upper limb after CDPT.
Interventions
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Low-Level Laser Therapy (904 nm)
Low-level laser therapy using the LTU-904 device (RianCorp, Australia) at a wavelength of 904 nm, applied to the fibrotic area of the upper limb after CDPT.
Low-Level Laser Therapy (650 nm)
Low-level laser therapy using the Salus Talent device (Remed, USA) at a wavelength of 650 nm, applied to the fibrotic area of the upper limb after CDPT.
Sham Laser Therapy
Placebo laser therapy with no active laser emission, administered after CDPT.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of trauma, metastasis, or infection in both arms
18 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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Jin A Yoon, MD, Ph.D
Associate Professor, Department of Rehabilitation Medicine
Principal Investigators
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Jin A Yoon, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Locations
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Pusan National University Hospital
Busan, Seo-Gu, South Korea
Countries
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References
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Other Identifiers
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D-2310-029-132
Identifier Type: -
Identifier Source: org_study_id
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