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 (ClinicalTrials.gov 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.