Tibetan herbal pain-relieving plaster for chronic musculoskeletal pain among cancer survivors: Study protocol of a randomized, double-blind, placebo-controlled trial Journal Article


Authors: Yang, M.; Baser, R. E.; Li, S. Q.; Hou, Y. N.; Chong, K.; Zhang, Y. L.; Hoque, I.; Bao, T.; Mao, J. J.
Article Title: Tibetan herbal pain-relieving plaster for chronic musculoskeletal pain among cancer survivors: Study protocol of a randomized, double-blind, placebo-controlled trial
Abstract: Chronic pain is common and debilitating in cancer survivors. Tibetan herbal pain-relieving plaster is used as an external analgesic to treat musculoskeletal pain in China; however, its safety and efficacy have not been evaluated via clinical trials in cancer survivors. We designed this Phase II randomized, double-blind, placebo-controlled trial ( Identifier: NCT04916249) to assess the efficacy and safety of the pain-relieving plaster for temporary pain relief among cancer survivors with chronic musculoskeletal pain. Under ethical approval from the Institutional Review Board at the Memorial Sloan Kettering Cancer Center, we will enroll eligible cancer survivors who have a clinical diagnosis of moderate to severe chronic musculoskeletal pain in this study. We use a central randomization system to allocate the eligible participants to either the treatment or the control group in a 1:1 ratio, with stratification by baseline opioid use. We will instruct the participants to apply the herbal patch (Tibetree Pain-Relieving Plaster, Tibet Cheezheng Tibetan Medicine Co. Ltd., Tibet, China) or placebo patch daily at the focal area with worst pain for 14 consecutive days. Study physician, participant, outcome assessor, and biostatistician are blinded to the group allocation. The primary outcome is pain severity measured by the Brief Pain Inventory on Days 2-7. Secondary outcomes include changes in insomnia, anxiety, depression, fatigue, pressure pain threshold, pain medication use, and global impression of change. We will also monitor the adverse events throughout the study period. Statistical analysis will follow the intention-to-treat principle and linear mixed modeling will be used. With rigorous design and implementation, this randomized, placebo-controlled trial will provide the initial evidence on the efficacy and safety of the pain-relieving plaster for pain relief among cancer survivors with chronic musculoskeletal pain.
Keywords: clinical trial; cancer survivor; safety; chronic pain; health; validation; randomized; efficacy; sensitivity; study design; patient reported outcome; nonsteroidal antiinflammatory drugs; hospital anxiety; depression scale; fibromyalgia; clinical importance; insomnia severity index; tibetan herbal patch; (pro); pressure-pain
Journal Title: Frontiers in Pharmacology
Volume: 13
ISSN: 1663-9812
Publisher: Frontiers Media S.A.  
Date Published: 2022-05-01
Start Page: 878371
Language: English
ACCESSION: WOS:000797864100001
DOI: 10.3389/fphar.2022.878371
PROVIDER: wos
PMCID: PMC9114465
PUBMED: 35600872
Notes: Article -- 878371 -- Source: Wos
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MSK Authors
  1. Raymond E Baser
    135 Baser
  2. Ting   Bao
    76 Bao
  3. Jun J Mao
    247 Mao
  4. Qing Susan Li
    82 Li
  5. Yen Nien Hou
    8 Hou
  6. Yi Lily Zhang
    10 Zhang
  7. Mingxiao Yang
    17 Yang
  8. Irfan Hoque
    1 Hoque
  9. Kamyar Michael Chong
    1 Chong