JMIR research protocols · 2026
Safety and Effectiveness of an Integrative Treatment of Acupuncture-Based Intervention in Survivors of Breast Cancer With Postmastectomy Pain Syndrome: Protocol for a Single-Center, Single-Arm Exploratory Trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kawasaki Naruaki, Ishiki Hiroto, Matsubara Naho, Ikegami Takako, Ishikawa Ayaka, Arakawa Sayaka, Takahashi Asuka, Uchida Tomoko, Nameki Yukie, Horiguchi Yoko, Murata Takeshi, Takayama Shin, Suto Akihiko, Kihara Kota, Ariyoshi Keisuke, Oyamada Shunsuke, Kayano Ayako, Matsuoka Hiromichi, Takagi Tatsuya, Satomi Eriko
Аннотация
BACKGROUND: Postmastectomy pain syndrome (PMPS) is a prevalent chronic pain condition that occurs after breast cancer surgery, often impairing quality of life in survivors of breast cancer. Despite its prevalence, no standardized treatment has been established. Acupuncture has been reported to be an efficacious intervention for the management of chronic pain and may be an effective treatment for PMPS.
OBJECTIVE: This study aims to explore the effectiveness and safety of integrative treatment of acupuncture-based intervention for PMPS.
METHODS: This is a single-center, single-arm, prospective interventional study. Eligible participants are patients with breast cancer who experience chronic postoperative pain in the chest, neck, or shoulder with a numerical rating scale (NRS) score ≥4, are at least 6 months postcurative treatment, have no evidence of disease recurrence, and are not receiving anticancer treatment at enrollment. Participants will receive the intervention once weekly for 12 sessions, followed by a 4-week observation period. The primary end point is the change in the average pain NRS score from baseline to week 16.
RESULTS: The study commenced in October 2023 and is scheduled to continue through March 31, 2027. The first participant was enrolled on October 24, 2023. As of the manuscript submission, 24 patients have been enrolled.
CONCLUSIONS: This study will explore the potential role of an integrative treatment of acupuncture-based intervention in the management of PMPS. The results will contribute to the evidence base for acupuncture in PMPS and inform the design of future clinical studies.
OBJECTIVE: This study aims to explore the effectiveness and safety of integrative treatment of acupuncture-based intervention for PMPS.
METHODS: This is a single-center, single-arm, prospective interventional study. Eligible participants are patients with breast cancer who experience chronic postoperative pain in the chest, neck, or shoulder with a numerical rating scale (NRS) score ≥4, are at least 6 months postcurative treatment, have no evidence of disease recurrence, and are not receiving anticancer treatment at enrollment. Participants will receive the intervention once weekly for 12 sessions, followed by a 4-week observation period. The primary end point is the change in the average pain NRS score from baseline to week 16.
RESULTS: The study commenced in October 2023 and is scheduled to continue through March 31, 2027. The first participant was enrolled on October 24, 2023. As of the manuscript submission, 24 patients have been enrolled.
CONCLUSIONS: This study will explore the potential role of an integrative treatment of acupuncture-based intervention in the management of PMPS. The results will contribute to the evidence base for acupuncture in PMPS and inform the design of future clinical studies.