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Rationale: CBD is commonly being used as an over-the-counter treatment for arthritis-related pain, however no clinical trial has been performed to establish efficacy.
Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for thumb basal joint arthritis.
Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Study Population: 40 subjects with presenting with thumb basal joint arthritis over the age of 18 will be recruited from the UVA Hand Center.
Description of Sites/Facilities Enrolling Participants: This will be a single-site study conducted at the UVA Hand Center at the University of Virginia.
Description of Study Intervention: The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the case (CBD) or control cream and then crossover to the other cream for 2 more weeks. Patients will apply the topical cream at their thumb basal joint one time daily for 1 hour. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to serious adverse events are noticed, the creams will be removed immediately and appropriate care and observation will be taken. Each condition will last for 2 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition. To capture any delayed-onset adverse events, including those related to skin changes that might develop after the drug is discontinued, subjects will attend a follow-up visit seven (7) days following the last dose of investigational cream.
Study Duration: This study will last one year from the beginning of subject recruitment to data analysis.
Participant Duration: Subjects will be enrolled in this study for approximately five (5) weeks from Screening until the final Study Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start with CBD | Active Comparator | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD and then crossover to the other condition (Shea butter only ) for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. |
|
| Start with control (Shea butter) | Active Comparator | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of Shea butter and then crossover to the other condition (CBD)for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | Topical CBD application for thumb basal joint osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Strength During Intervention and at Follow-up. | Grip strength, kg. | Change from baseline to 2 weeks |
| Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up. | The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population. | Change from baseline to 2 weeks |
| Change in Kapandji Score | Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition. | Change from baseline to 2 weeks |
| Change in Hand Range of Motion | Metacarpal phalangeal (MP) range of motion, passive extension. | Change from baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Side Effects Using Novel CBD Cream. | Side effects will be assessed at each encounter clinical evaluation by patient report in a Symptom Diary. All side effects thought to be secondary to CBD will be documented. | Change from baseline to 2 weeks |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | First CBD, Then Shea Butter | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD and then crossover to the other condition (Shea butter only ) for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. CBD: Topical CBD application for thumb basal joint osteoarthritis. Shea Butter: Placebo Shae Butter for comparison |
| FG001 | First Shea Butter, the CBD | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of Shea butter and then crossover to the other condition (CBD)for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. CBD: Topical CBD application for thumb basal joint osteoarthritis. Shea Butter: Placebo Shae Butter for comparison |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Start With CBD | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD and then crossover to the other condition (Shea butter only ) for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. CBD: Topical CBD application for thumb basal joint osteoarthritis. Shea Butter: Placebo Shae Butter for comparison |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hand Strength During Intervention and at Follow-up. | Grip strength, kg. | Subjects served as their own control so 18 people completed each intervention. | Posted | Mean | Standard Deviation | KG | Change from baseline to 2 weeks |
|
AE's were evaluated during the course of the study- 42 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBD Intervention | Time during which subjects were exposed to CBD oil intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent DeGeorge, MD | University of Virginia | 434.982.4263 | BD6U@uvahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 | Jul 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2020 | Jul 16, 2024 | ICF_001.pdf |
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Randomized controlled trial with crossover
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| Shea Butter | Drug | Placebo Shae Butter for comparison |
|
| BG001 | Start With Control (Shea Butter) | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of Shea butter and then crossover to the other condition (CBD)for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. CBD: Topical CBD application for thumb basal joint osteoarthritis. Shea Butter: Placebo Shae Butter for comparison |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Shea Butter Group | The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of Shea butter and then crossover to the other condition (CBD)for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. CBD: Topical CBD application for thumb basal joint osteoarthritis. Shea Butter: Placebo Shae Butter for comparison |
|
|
| Primary | Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up. | The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population. | Subjects served as their own control so 18 people completed each intervention. | Posted | Mean | Standard Deviation | score on a survey | Change from baseline to 2 weeks |
|
|
|
| Primary | Change in Kapandji Score | Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition. | Subjects served as their own control so 18 people completed each intervention. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 2 weeks |
|
|
|
| Primary | Change in Hand Range of Motion | Metacarpal phalangeal (MP) range of motion, passive extension. | Subjects served as their own control so 18 people completed each intervention. | Posted | Mean | Standard Deviation | degrees | Change from baseline to 2 weeks |
|
|
|
| Secondary | Rate of Side Effects Using Novel CBD Cream. | Side effects will be assessed at each encounter clinical evaluation by patient report in a Symptom Diary. All side effects thought to be secondary to CBD will be documented. | Subjects served as their own control so 18 people completed each intervention. | Posted | Count of Participants | Participants | Change from baseline to 2 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Shea Butter Intervention | Time during which subjects were exposed to Shea Butter intervention. | 0 | 18 | 0 | 18 | 0 | 18 |
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