Hallux ValgusPhase 2/3NCT04103814
Effect of Topical CBD Cream for Degenerative Hallux Disorders
A Phase 2/3 study testing magnesium-cannabidiolic acid cream in people with Hallux Valgus and Hallux Rigidus, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Hallux Rigidus
- What is being tested?
- magnesium-cannabidiolic acid cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2019to 15 May 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a new diagnosis of hallux rigidus or hallux valgus
- VAS pain score of 4 or higher
- Age > 18 years
- The patient provides informed consent
Who cannot join
- A 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, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
About this study
Official title: Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hallux Valgus, Hallux Rigidus
- Being tested
- magnesium-cannabidiolic acid cream, Placebo cream
- Medical subject headings
- Hallux Valgus, Hallux Rigidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium-cannabidiolic acid creamDrug
Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus.
Placebo creamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mg-CBDa cream | Active comparator | Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus. Receives: Drug: magnesium-cannabidiolic acid cream |
| Placebo cream | Placebo comparator | 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. Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment VAS Score Averaged Daily Over 4 Weeks.
Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.
Measured: 4 weeks
Weekly Foot Function Index
The foot function index (FFI) is a questionnaire that measures foot pain and disability. It is self-administered and consists of 23 items divided into 3 subscales (pain, disability, and activity limitation). The pain subcategory consists of 9 questions (scored out of 90) and is a measure of pain in different situations, such as walking with shoes versus barefoot. The disability subcategory consists of 9 questions (scored out of 90) and measures functional activities, such as difficulty walking upstairs. The activity limitation subcategory consists of 5 questions (scored out of 50) and measures limitations caused by the foot problem. All three subcategories are summed together to get a final number, with higher numbers indicating worse pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start20 Oct 2019
- Primary completion15 May 2023
- Study completion15 May 2023
Why it stopped: Lack of resources to continue enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will receive either active Mg-CBDa (magnesium-cannabidiolic acid) cream or placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-America Orthopaedic Association
- Responsible party
- Sponsor
- Investigators
- Simon Lee, MD, Principal investigator, Midwest Orthopaedics at Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103814
- Sponsor's protocol ID
- 19052902
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2019
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical CBD Oil on Pain Scores for Hallux Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04103814
- Acronym / sponsor ID
- 19052902
- Conditions
- Hallux Valgus, Hallux Rigidus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources to continue enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Mid-America Orthopaedic Association
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled patients will receive either active Mg-CBDa (magnesium-cannabidiolic acid) cream or placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus.
| Arm | Type | Receives |
|---|---|---|
| Mg-CBDa cream | Active comparator | Drug: magnesium-cannabidiolic acid creamSubjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus. |
| Placebo cream | Placebo comparator | Drug: Placebo creamSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a new diagnosis of hallux rigidus or hallux valgus
- VAS pain score of 4 or higher
- Age > 18 years
- The patient provides informed consent
Key exclusion criteria (5 listed)
- A 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, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium-cannabidiolic acid creamPatients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus. | Drug | Mg-CBDa cream |
| Placebo creamPatients 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. | Drug | Placebo cream |
Primary outcome
Post-treatment VAS Score Averaged Daily Over 4 Weeks.
Time frame: 4 weeks
Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.
Weekly Foot Function Index
Time frame: 4 weeks
The foot function index (FFI) is a questionnaire that measures foot pain and disability. It is self-administered and consists of 23 items divided into 3 subscales (pain, disability, and activity limitation). The pain subcategory consists of 9 questions (scored out of 90) and is a measure of pain in different situations, such as walking with shoes versus barefoot. The disability subcategory consists of 9 questions (scored out of 90) and measures functional activities, such as difficulty walking upstairs. The activity limitation subcategory consists of 5 questions (scored out of 50) and measures limitations caused by the foot problem. All three subcategories are summed together to get a final number, with higher numbers indicating worse pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Lee, MD principal investigator
Midwest Orthopaedics at Rush
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing magnesium-cannabidiolic acid cream in people with Hallux Valgus and Hallux Rigidus, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment VAS Score Averaged Daily Over 4 Weeks. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.