Clinical trial NCT04103814
Conditions: Hallux Valgus Hallux Rigidus
Sponsor: Rush University Medical Center
Start date: 2019-10-20; Completion date: 2023-05-15
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Detailed description:
Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. While operative interventions exist, nonoperative modalities are the mainstay of treatment for most patients. Options include shoe wear modification, manual and physical therapy, intraarticular injection of corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot orthoses. Oral anti-inflammatories are the most effective non-operative strategy, but unfortunately, are associated with major adverse side effects and are contraindicated in many patients. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. This prospective randomized trial will compare topical CBD cream vs placebo cream for the treatment of pain secondary to hallux valgus and hallux rigidus. The primary outcome of interest in the change in pre and post-treatment Visual Analog System (VAS) pain scores. VAS pain score is a measurement on a continuum of values of pain intensity. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Arms: arm 1: Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus. arm 2: Subjects in this group will receive the inactive CBD cream for topical treatment of hallux valgus or hallux rigidus. The ingredients of the placebo cream are: butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), and food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.
Interventions: intervention 1: magnesium-cannabidiolic acid cream intervention 2: Placebo cream
Intervention descriptions: intervention 1: Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus. intervention 2: Patients will receive placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus. The ingredients of the placebo cream are as follows: Butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

Protocol documents:
ICF_001.pdf: 
 
 
Rush Template Version Date: 12/10/2018 
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Page 1 of 7 
 
 
CONSENT/AUTHORIZATION FOR PARTICIPATION IN A RESEARCH 
STUDY 
 
Site Principal Investigator: 
Simon Lee, MD 
Department: 
Department of Orthopedics 
Address and Contact Information: 1611 W Harrison St, Suite 300  
 
Chicago IL, 60612 
 
Simon.Lee@rushortho.com 
 
312-432-2340 
 
Protocol Title: 
Effect of Topical Chylobinoid Cream on Pain and Function 
Scores for Hallux Disorders: A Randomized Controlled Trial 
Sponsor(s): 
Rush Department of Orthopedics 
 
Name of Participant:  __________________________________________________________ 
 
Key Information: 
You are being invited to participate in a research study. Research studies answer important 
questions that might help change or improve the way we do things in the future. 
 
This consent form will give you information about the study to help you decide whether you 
want to participate. Please read this form, and ask any questions you have, before agreeing to be 
in the study. 
 
Taking part in this research study is voluntary. You do not have to participate in this study and 
may choose to leave the study at any time. If you decide not to participate in this study or leave 
the study at a later time, your health care, benefits, or relationship with Rush University Medical 
Center will not change or be affected.  
 
The purpose of this study is to determine if chylobinoid (CBD) cream can decrease pain in two 
degenerative conditions of the great toe: hallux valgus and hallux rigidus.  CBD is an active 
ingredient in many products. CBD cream is an investigational product not yet approved by the 
FDA for treatment of osteoarthritic pain. The term “investigational” means that the product has 
not been approved by the U.S. Food and Drug Administration (FDA) and must be tested to see if 
it is safe and effective treatment for this disease or condition. 
 
If you agree to participate in this study, your participation may last up to four weeks and you will 
be asked to complete a daily pain journal, a weekly survey regarding your toe pain and function, 
and return for one clinic follow up.  During the study period, you will be asked to use a topical 
cream as needed on your involved great toe, in addition to any other clinically indicated 
treatment such as orthotics or physical therapy. The CBD and placebo cream will be provided by 
the Department of Orthopaedics. 
 
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For a detailed list of study procedures, please see the “What are the activities you will be doing if 
you participate in this study?” section of this consent form. 
 
There are risks to you for participating in this study. In this study, there is a risk that your pain 
will not be improved by the CBD or placebo cream. The CBD and placebo cream will look 
exactly alike; however, the placebo cream contains inactive ingredients designed to have no real 
effect. The placebo cream is used in this study to determine whether the CBD cream has a real 
effect. The ingredients of the placebo cream are as follows: Butyrospermum parkii (shea butter), 
caprylic/capric triglycerides medium chain triglycerides (MCT oil), food coloring to match the 
CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch. 
 
Additionally, a risk of participating in this study is the potential for a breach of confidentiality. 
The research involves the collection or study of existing data, documents, and/or records (for 
medical history purposes). Data that develops as part of your routine care (such as lab results, 
medication dosages, etc.) will also be collected for this study. Once data is collected, that data 
will be de- identified for the data analysis and manuscript preparation. This means that no one 
outside of your study doctor and his research staff will have access to any of your identifying 
information, such as your name or birth date. 
 
You may benefit from taking part in this study. Studies on CBD derivatives in both animals and 
humans show that it may be of benefit to people with your condition or it may be as good as 
standard therapy with fewer side effects. However, because individuals respond differently to 
therapy, no one can know in advance if it will be helpful for you. 
 
If you are assigned to treatment with placebo, you are not expected to get any health benefits 
from participating in this study. You should not expect your condition to improve as a result of 
participating in this study. 
 
There are other options available to you if you decide not to participate in this study. You may 
choose another form of treatment or care for your hallux rigidus or hallux valgus without being 
in a study such as orthotics, steroid injections, oral anti-inflammatories, and physical therapy.  
CBD cream is available over-the-counter, and you can receive this treatment without being 
enrolled in the study if you desire.  You should discuss these other options with your study 
doctor.  
 
Detailed Information: Please review the rest of this document for details about 
the above topics and additional information you should know before making a 
decision about whether or not you will participate in this study. 
 
Why are you being invited to participate in this study? 
You are being asked to participate in this study because you have significant pain as a result of 
your hallux valgus or hallux rigidus, and you have not had a prior operation on your first 
metatarsal (bone in the foot just behind the big toe). 
 
How many participants will take part in this study? 
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Approximately 54 participants are expected to take part in this study here at Rush University 
Medical Center.  
 
What are the activities you will be doing if you participate in this study? 
If you agree to be in this study, you will be asked to participate in the following activities:  
 You will be randomized to either receive CBD cream or a placebo cream.  You and your 
doctor will be blinded to the type of cream that you receive. 
 Apply the given cream to your involved great toe as many times as needed 
 Complete a daily pain journal for the four weeks of treatment 
 Complete a weekly email survey regarding your foot pain and how the pain impacts your 
daily life (Foot Function Index) 
 Return to clinic after four weeks of treatment, and answer 2 brief questions regarding the 
treatment 
 Return your unused cream to the study personnel 
 
Will your information be used for research in the future? 
Information collected from you for this study may be used for future research or shared with 
other researchers. If this happens, information which could identify you will be removed before 
any information is shared. Since identifying information will be removed, you will not be asked 
for additional consent. 
 
What are the risks and discomforts of participating in this study? 
There is a chance that you do not see improvement of the pain related to your hallux valgus or 
hallux rigidus if you are in the placebo group.  This will not place you at increased risk for 
progression of your disease. While CBD is not FDA approved for use in inflammatory/arthritis 
conditions, it has been FDA approved for other conditions.  There are no known side effects 
associated with topical use. 
 
This study involves collection information from your medical records and surgery. The only risk 
is the release of confidential personal health information. We will take every precaution to 
protect your information. All data collected will be protected on a password protected encrypted 
computer. Information identifying subjects will not be released to the public. Once all data is 
collected and analyzed we will remove all identifying data. 
 
During this study, you will be told about important findings (either good or bad), such as changes 
in the risks or benefits of participation in the study or new choices to participation that might 
cause you to change your mind about being in the study. If new information is shared with you, 
you may be asked to sign a revised consent form in order to continue participating in this study.  
 
Are there any anticipated pregnancy risks? 
If you are pregnant you cannot take part in this study. Women with known pregnancy will be 
excluded from the study. In the routine care of foot and ankle patients, a pregnancy test is not 
administered prior to these radiographic tests. If you already know you are pregnant, or think you 
may be pregnant, please inform the study staff, and you will not be included in the study to avoid 
any even minimal additional radiation.  
 
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Can you leave or be removed from this study? 
You have the right to leave a study at any time without penalty. For your safety, however, you 
should consider the study doctor’s advice about how to leave this study. If you leave this study 
before the final study visit, the study doctor may ask you to complete the final steps. If you chose 
to leave the study, you will be required to return the treatment cream which was given to you at 
the beginning of the study. There are no safety concerns for stopping the study early. The 
researchers also have the right to stop your participation in this study without your consent if: 
 They believe it is in your best interests; 
 You do not follow the instructions; 
 The study is cancelled for any reason. 
 
What about confidentiality of your medical information? 
This authorization is voluntary. Rush University Medical Center and its affiliates (“Rush”) will 
not withhold or refuse your treatment, payment, enrollment, or eligibility for benefits if you sign 
this authorization. You do not have to sign this authorization, but that means that you cannot be 
in the study or receive study-related treatment. 
 
By signing this document, you voluntarily authorize (give permission to) Dr. Lee, his study team, 
and other Rush personnel involved with the conduct and review of this study (which may include 
off-site personnel) to use or disclose (release) health information that identifies you for the study 
described in this document. 
 
During the study, Dr. Lee and his study team will collect Protected Health Information (PHI) 
about you for the purposes of this research. PHI is your health information that includes your 
medical history and new information obtained as a result of this study. Some of this information 
will come from your medical record. The health information that Rush may use or disclose for 
this research includes: 
 Age, weight, other medical comorbidities, pre and post treatment pain scores, severity of 
hallux rigidus or hallux valgus, other prescribed treatment modalities, physical exam 
results, and Foot Function Index Scores.  
 
Dr. Lee and his study team may share your health information and the results of your study-
related procedures and tests with people outside of Rush who assist with the conduct and review 
of this study. The persons who receive your health information may not be required by Federal 
privacy laws to protect it and may share your information with others without your permission, 
but only if permitted by the laws governing them. Your health information described above may 
be used or disclosed to: 
 To the Researchers  
 Monitoring agencies such as the Food and Drug Administration (FDA), the National 
Institutes of Health and the Rush Institutional Review Board (IRB). 
 
While you participate in the study you will have access to your medical record, but Dr. Lee is not 
required to release to your study information that is not part of your medical record. Rush is 
required by law to protect your health information, and study records that identify you will be 
kept confidential. The results of study tests/procedures performed as part of this study may 
become part of your medical record. Any study information in your medical record will be kept 
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indefinitely. Your identity will not be revealed on any report, publication, or at scientific 
meetings.  
 
You have a right to inspect and copy the information to be disclosed with this authorization and 
you may obtain a copy of the information by contacting the office listed above. 
 
If you no longer want to be in the study and do not want your future health information to be 
used, you may change your mind and revoke (take back) this authorization at any time by writing 
to Dr. Lee at 1611 W Harrison St, Suite 300, Chicago IL 60612. If the authorization is revoked, 
you will no longer be allowed to participate in the study and previously authorized 
individuals/entities may still use or disclose health information that they have already obtained 
about you as necessary to maintain the integrity or reliability of the current study. 
 
This authorization is valid for the entirety of this research study. It will expire upon completion 
of the study or if you revoke (take back) the authorization. 
 
If you withdraw from this study, the data already collected from you may not be removed from 
the study records. The study doctor and/or study team may ask you whether they can continue to 
collect follow-up data on you. If follow-up information will be requested, you will be asked to 
sign a separate consent form before this information can be collected. 
 
Records of participation in this study will be maintained and kept confidential as required by 
law. All study data will be stored on a secure serve at Midwest Orthopedics at Rush.  All stored 
data will be deidentified.  Study materials will be password protected and only available to the 
study team. 
 
The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this 
research study. The IRB is a special committee that reviews new and ongoing human research 
studies to check that the rules and regulations are followed regarding the protection of the rights 
and welfare of human participants. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.  
 
What are the costs to participate in this study? 
The CBD and placebo cream will be provided to you free of charge by the Department of 
Orthopaedics. All other costs that are part of your usual medical care, such as clinical visits, 
surgery, and any tests associated with these visits will be charged to you or your insurance 
company. You will be responsible for all costs that are not paid by your insurance company. You 
should check with your insurance company before you enroll in this study. 
 
Will you be paid for your participation in this study? 
You will not be paid for being in this study. 
 
Investigator Dual-Role 
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Your doctor, who is also the person responsible for this research study, is interested in both your 
clinical care and the conduct of this study. You have the right to discuss this study with another 
person who is not part of the research team before making your decision whether or not to be in 
the study. 
 
Who can you contact for more information about this study? 
Questions are encouraged. If you have further questions about this study, you may call Elizabeth 
Terhune (Research Coordinator) at (801) 824-9805 or email her at 
elizabeth_b_terhune@rush.edu. 
 
Who can you contact if you have concerns about your rights as a study participant? 
Questions about the rights of research participants may be addressed to the Rush University 
Medical Center Office of Research Affairs at 1-800-876-0772. 
 
What are your rights as a study participant? 
Taking part in this study is voluntary. If you choose not to participate in this study or to leave the 
study at any time, your health care, benefits or relationship at Rush University Medical Center 
will not change or be affected. 
 
If you choose to leave this study and you do not want any of your information to be used, you 
must inform Dr. Lee in writing at the address on the first page. Dr. Lee may still use your 
information that was collected prior to your written notice. 
 
 
 
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SIGNATURE BY THE PARTICIPANT  
By signing below, you are consenting to participate in this research study. You have read the 
information given or someone has read it to you. You have had the opportunity to ask questions, 
which have been answered satisfactorily to you by the study staff. You do not waive any of your 
legal rights by signing this consent form. You will be given a signed copy of this consent. 
 
_________________________________ 
_______________________ __________________ 
Name of Participant  
 
 
Signature of Participant 
Date of Signature 
 
 
SIGNATURE BY THE INDIVIDUAL OBTAINING CONSENT: 
I attest that all the elements of informed consent described in this consent document have been 
discussed fully in non-technical terms with the participant. I further attest that all questions asked 
by the participant were answered to the best of my knowledge. 
 
_______________________________________________________ 
__________________ 
Signature of Individual Obtaining Consent  
 
 
 
Date of Signature 
 
 
SIGNATURE BY WITNESS/INTERPRETER: 
I observed the signing of this consent document and attest that, to the best of my knowledge, the 
person signing the consent form is the participant and the person signing the form has done so 
voluntarily. 
 
_______________________________________________________ 
Name of Witness/Interpreter 
 
_______________________________________________________ 
__________________ 
Signature of Witness/Interpreter 
 
 
 
 
 
Date of Signature 
 
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Prot_000.pdf: 
 
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Title: Effect of Topical Chylobinoid Cream on Pain and Function Scores for Hallux 
Disorders: A Randomized Controlled Trial 
 
Purpose: The purpose of this study is to compare the change in pain scores in patients 
with hallux rigidus and hallux valgus who are treated with topical cannabidiol cream vs. 
placebo.   
 
Hypothesis: Patients treated with topical 1.5% chylobinoid cream (chylobinoid is 
approximately 85% magnesium-cannabidiolic acid or Mg-CBDa, 5% CBD, 5% other 
cannabinoids, and naturally occurring plant lipids in a neutral emollient) will show 
improvement in hallux pain compared to those patients treated with placebo. 
 
Background:  
Conditions affecting the first metatarsophalangeal (MTP) joint are highly prevalent and 
make up a significant portion of orthopedic foot and ankle clinic visits.  Hallux rigidus, 
Latin for “stiff toe,” is the term for osteoarthritis of the first MTP joint.  It is the most 
common form of foot arthritis, and incidence continues to rise as the population ages.1 
Hallux valgus is a common foot deformity characterized by chronic subluxation of the 
first MTP joint, with lateral deviation of the proximal phalanx and medial deviation of 
the first metatarsal.  These conditions represent a large portion of chronic forefoot 
disorders. 
 
Both of these chronic conditions are associated with pain, inflammation, functional 
impairment, and corresponding radiographic changes. While operative interventions 
exist, nonoperative modalities are the mainstay of treatment for most patients.  Options 
include shoe wear modification, manual and physical therapy, intraarticular injection of 
corticosteroids or sodium hyaluronate, oral nonsteroidal anti-inflammatories, and foot 
orthoses. Oral anti-inflammatories are some of the most effective non-operative 
strategies, but unfortunately are associated with major adverse side effects and are 
contraindicated in many patients. Although these medications do not alter the underlying 
deformity, they are an important, cost-effective, and clinically validated tools in the 
management of hallux valgus and hallux rigidus.  Oral non-steroidal anti-inflammatories 
(NSAIDs) are contraindicated in many patients with certain gastrointestinal, renal, or 
cardiac disease. 
 
The endocannabinoid system has been shown to play an important role in inflammatory 
regulation, and pain perception.2 Cannabidiol (CBD) is a component of the cannabis plant 
that is responsible for the signaling mechanism of cannabinoid receptions involved in a 
variety of pain pathways.  CBD has been found to suppress progression of arthritis by 
suppressing the inflammatory cytokine pathway involved in osteoarthritis.3 It has been 
found to reduce synovitis and decrease progression and pain secondary to osteoarthritis.  
Philpott et al. assessed pain behavior and joint afferent mechanosensitivity in rats with 
collagen-induced osteoarthritis of the knee.  They found that CBD infusion decreased 
joint inflammation, inhibited mechanosensitivity of joint nociceptors, and improved hind 
limb weight bearing and limb withdrawal threshold.2  Transdermal CBD was found to 
reduce joint swelling, immune cell infiltration, and synovial thickening in a dose-
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V07/08/2021 
dependent manner in rats with induced knee arthritis.4 This and other studies show 
preliminary evidence that CBD is a safe, effective way to improve pain and functional 
impairment associated with osteoarthritis.5,6 
 
CBD and its more active form, CBDA, have been studied since the 1960s, and different 
formulations and administrations have been shown to treat a wide variety of pathology.  
In the 1970s, publications on the compound increased after research found antiepileptic 
effects with systemic administration.  Recent studies have focused on anti-inflammatory 
and antioxidative effects after both IV and topical administration.  Studies have evaluated 
oral CBD for pain in patients with kidney disease, multiple sclerosis, spinal cord injury, 
brachial plexus injury, and limb amputation.7–10  CBD has been found to decrease 
generalized pain and increase function after short term.   
 
Topical use for orthopedic disorders has yet to be studied, although the available 
literature shows that topical CBD application has therapeutic potential for relief of 
arthritis pain-related behaviors and inflammation without evidence side effects. More 
recently, a topical chylobinoid cream formulation has become available for study. 
Chylobinoid describes a chylomicron-like complex extracted from raw hemp flower 
utilizing a proprietary mineral infusion process developed by Synthonics, Inc. that 
consists of approximately 85% magnesium-cannabidiolic acid or Mg-CBDa, 5% CBD, 
5% other cannabinoids, and naturally occurring plant lipids.                            
 
This study would be the first prospective randomized controlled trial to evaluate the use 
of topical chylobinoid cream in the treatment of hallux rigidus and hallux valgus.  It has 
the potential to improve pain and function for patients who suffer from moderate to 
severe hallux pain, with low cost and minimal side effects.  Additionally, it may 
significantly reduce the concurrent need for narcotics, NSAIDs, corticosteroids and other 
oral/topical analgesic remedies. 
 
 
Study design: Prospective randomized controlled trial 
 
Inclusion criteria:  
- 
Patients with new diagnosis of hallux rigidus and hallux valgus 
- 
VAS pain score of 4 or higher 
- 
Age > 18 years 
- 
Patient provides informed consent 
 
Exclusion criteria: 
- 
Previous operative procedure to the first metatarsal for treatment of hallux valgus 
or hallux rigidus 
- 
VAS pain score at presentation less than 4 
- 
Concomitant hallux valgus and hallux rigidus on the ipsilateral side 
- 
Allergy to CBD, CBDa or any other ingredient contained in the topical cream 
- 
Pregnant patients 
- 
Non-English speaking patients 
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V07/08/2021 
- 
Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate 
informed consent 
 
Patients and protocols: 
Patients will be recruited from the practices of a fellowship trained Orthopedic Foot and 
Ankle surgeon at Rush University Medical Center. Patients with a new diagnosis of 
hallux valgus or hallux rigidus without prior operative intervention on the first metatarsal 
will be approached for enrollment in the study. Pre-treatment VAS pain scores and the 
Foot Function Index (FFI) are collected as a routine question on new patient 
questionnaires. Patient’s with a VAS pain score of < 4 will be excluded.  The goal of the 
intervention is to improve pain, and patient’s with minimal pain at presentation have a 
little possibility of showing therapeutic response.  
 
Enrolled patients will be randomized to receive chylobinoid cream vs. placebo cream 
(neutral emollient containing no active agent) for topical treatment of hallux rigidus or 
hallux valgus. Patients and treating physician will be blinded to the intervention.  Patients 
will not be charged nor will their insurance be billed for cost of the chylobinoid cream or 
placebo cream. Patients will be instructed to apply the topical cream as needed for pain 
for a total duration of four weeks. This topical treatment will be combined with other 
commonly employed conservative modalities, including physical therapy and orthotics as 
clinically indicated.  Patient’s will receive the FFI survey via email weekly for a total of 4 
weeks after treatment initiation. Patient’s will be instructed to keep track of daily VAS 
pain scores in a pain journal for the four weeks of treatment.  
 
Patient’s will attend their regularly scheduled four weeks follow up clinic visit.  Post-
treatment VAS pain score will be collected at that visit, along with their daily pain 
journal.  Patients will fill out a brief survey regarding their experience with the treatment.  
The remaining chylobinoid cream will be collected from patients and weighed in order to 
assess the amount of product used during the four-week study period. The difference in 
pre and post-treatment VAS score and FFI will be determined between the chylobinoid 
and placebo groups. 
 
Sample Size: 
Power analysis was preformed using a retrospective review of internal patients with new 
hallux rigidus and hallux valgus diagnoses.  VAS scores at the time of presentation were 
determined.  VAS score at presentation for hallux rigidus was 6.74 with standard 
deviation of 1.7.  VAS score at presentation for hallux valgus was 6.45 with standard 
deviation of 1.68.  A clinically significant improvement in VAS pain score was defined 
as a 2-point decrease.  Power analysis based on 80% power and alpha of .05 for detection 
of a 2-point decrease in VAS score determined the study would require 12 patients with 
hallux rigidus per group (24 total) and 12 patients with hallux valgus per group (24 total). 
In order to account for 20% loss to follow up, a total of 28 patients will be enrolled for 
each hallux rigidus and hallux valgus group (56 total patients for the entire study). 
 
Demographics/patient specifics:  
Age, sex, medical co-morbidities, weight, height, pre-treatment pain scores, BMI 
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Primary outcome measure: Post-treatment VAS score averaged daily over 4 weeks. 
 
Secondary outcome measures: 
1. Pre- to post-treatment difference in VAS score 
2. Pre- to post-treatment difference in FFI 
3. Post-treatment FFI at different time points (1, 2, 3, and 4 weeks post treatment) 
4. Adherence to treatment 
5. Amount of Chylobinoid cream vs. Placebo cream used during the study period 
6. Do you believe you received the treatment or placebo? (4 weeks) 
7. Did the cream we gave you help with your pain? (4 weeks) 
 
Procedures for maintaining confidentiality:  
A breach of confidentiality and/or privacy is a risk of this study. To prevent this, all 
collected data will be stored electronically in password-protected files to protect patient 
identity and information. All information will be collected and reviewed by the research 
team only. Data will be maintained on a password-protected computer that will be 
accessible only to the study team. No patient identifiers will be maintained in the 
database. 
 
 
 
 
 
 
 
 
References: 
1.  
Hamid KS, Parekh SG. Clinical Presentation and Management of Hallux Rigidus. 
Foot Ankle Clin. 2015;20:391-399. doi:10.1016/j.fcl.2015.04.002 
2.  
Philpott HT, O’brien M, Mcdougall JJ. Attenuation of early phase inflammation by 
cannabidiol prevents pain and nerve damage in rat osteoarthritis. Pain. 
2017;158:2442-2451. doi:10.1097/j.pain.0000000000001052 
3.  
Malfait AM, Gallily R, Sumariwalla PF, et al. The nonpsychoactive cannabis 
constituent cannabidiol is an oral anti-arthritic therapeutic in murine collagen-
induced arthritis. Proc Natl Acad Sci U S A. 2000;97(17):9561-9566. 
doi:10.1073/pnas.160105897 
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Hammell DC, Zhang LP, Ma F, et al. Transdermal cannabidiol reduces 
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