Yeahhh Baby! Ointment on Hip and/or Knee Pain in Men and Women

Study Overview
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Brief Summary
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This study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index [WOMAC] and visual analog scale [VAS] for pain).

Detailed Description
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Joint pain is a common ailment among adults in the United States. In 2014, an estimated 14.6 million Americans with arthritis suffered from severe joint pain. It is therefore unsurprising that many topical ointments are currently marketed for joint pain relief including Bengay®, Icy Hot®, Jointflex®, and Aspercreme®. These ointments aim to reduce pain often through a combination of analgesic ingredients include capsaicin, salicylates, menthol, camphor, and lidocaine. Bengay® products, for instance, contain one or more of menthol, camphor, salicylates, and lidocaine. Icy Hot® products contain menthol, while some also include lidocaine. Yeahhh Baby! ointment is an herbal (botanical: plant-based) treatment for those impacted by joint pain. The product contains a variety of herbal ingredients that have been touted by some within the alternative medicine community as healing agents. The product started selling in 2016 and is available commercially as an all-natural alternative to other commercially available products. This ointment consists primarily of coconut oil (98%), with magnesium and small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing. The present study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index [WOMAC] and visual analog scale [VAS] for pain).

Official Title
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Effect of Yeahhh Baby! Ointment on Efficacy to Relieve Joint Pain in Men and Women With Hip and/or Knee Pain

Conditions
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Joint Pain

Intervention / Treatment
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* Dietary Supplement: Yeahhh Baby Ointment
* Other: Coconut oil ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days Recreationally active (2 or more days per week) Not obese (BMI < 30kg/m2) Exclusion Criteria: Tobacco users/Smokers Allergic to coconut, walnuts, oak, olives Currently using anti-inflammatory medicines or dietary supplements (and not willing to cease for one-month prior to participation and throughout study)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double-blinded crossover
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yeahhh Baby Ointment<br>Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms. | Dietary Supplement: Yeahhh Baby Ointment<br>* The ointment consists primarily of coconut oil (98%), with small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing.<br>|
| Placebo Comparator: Placebo Ointment<br>Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms. | Other: Coconut oil ointment<br>* Coconut oil ointment with a little olive oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint pain visual analog scale | A 100mm visual analog scale will be used to assess join pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree) | days 1-14 | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most. | days 1-14 | 
| Blood pressure | Resting blood pressure will be measured. | First 1 day | 
| Blood pressure | Resting blood pressure will be measured. | 15th day | 
| Heart Rate | Resting heart rate will be measured. | First 1 day | 
| Heart Rate | Resting heart rate will be measured. | 15th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, knee, topical