Tibetree Pain-Relieving Plaster for Musculoskeletal Pain Among Cancer Survivors
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 68
- Locations
- 13
- Primary Endpoint
- Brief Pain Inventory - Measure of Participant Pain
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study coordinators, patients, PI, co-investigators, biostatisticians will be blinded to which treatment group the patient was assigned to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 18 years or older
- •A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria will not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites
- •Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
- •Patients currently have no evidence of disease
- •Ambulatory (Karnofsky functional score of ≥ 60)
- •Having a focused location of regional musculoskeletal pain (e.g. joints, extremities, back, neck) that can be covered by one patch of PRP
- •Worst pain score (numeric pain rating scale) 5 or above in the preceding week
- •Pain for at least 3 months and at least 15 days with pain in the preceding 30 days; and willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible choices
- •Able to understand informed consent and provide signed informed consent form
Exclusion Criteria
- •Patients with non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) will be excluded if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.
- •Patients have generalized musculoskeletal pain such as fibromyalgia
- •Use of corticosteroid drugs by any route of administration within 30 days
- •Patients with significant self-reported skin disorders
- •Patients with open wounds, infections, skin trauma at skin overlying area of pain
- •Patients with documented history of skin sensitivity to adhesive or allergic reaction to other patches or topical analgesics
- •Patients with documented skin allergic reaction to plants or herbs
- •Patients who are in active treatment (chemotherapy, surgery, radiotherapy)
- •Plan to change or initiate other pain medications or interventions (e.g. physical therapy, acupuncture, injection). Patients may remain on their current pain regimen.
Arms & Interventions
Placebo plaster groups
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.
Intervention: Placebo (Other)
Tibetree pain relieving plaster
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.
Intervention: Tibetree Pain Relieving Plaster (Drug)
Outcomes
Primary Outcomes
Brief Pain Inventory - Measure of Participant Pain
Time Frame: 14 days from baseline
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.
Secondary Outcomes
No secondary outcomes reported