Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Pain

Musculoskeletal Pain

Participants with chronic musculoskeletal pain for ≥ 3 months and with BPI worst pain rated 5 or greater during the preceding week will be eligible for the study. We will enroll 66 participants with 33 patients in each arm.

Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.

Tibetree Pain Relieving Plaster

Placebo

Jun Mao, MD, MSCE

The purpose of this study is to find out whether Tibetree Pain Relieving Plaster, an herbal pain relief patch, may be able to reduce this pain. Tibetree Pain Relieving Plaster is available as an over-the-counter (non-prescription) treatment for the temporary relief of minor aches and pains in muscles and joints. This study is the first to test this treatment in people who have had cancer.

This is a single-center, two-arm, randomized, placebo-controlled trial comparing Tibetree PRP with a placebo control plaster.

The study coordinators, patients, PI, co-investigators, biostatisticians will be blinded to which treatment group the patient was assigned to.

Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors

Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference). A pain severity subscale score can be computed by taking the average rating of the 4 pain severity items. This subscale will be our primary outcome measure. A pain interference subscale score can be similarly computed for the 7 pain interference items. BPI should be completed prior to removing pain relieving plaster at the end of each day.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors	NCT04916249	Cancer Remission	Tibetree Pain R... Placebo	18 Years -	Memorial Sloan Kettering Cancer Center
Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors	NCT04916249	Cancer Remission	Tibetree Pain R... Placebo	18 Years -	Memorial Sloan Kettering Cancer Center

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