Trial Outcomes & Findings for Is Topical CBD Effective in Treating Thumb Joint Arthritis (NCT NCT04611347)
NCT ID: NCT04611347
Last Updated: 2025-07-03
Results Overview
Grip strength, kg.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Change from baseline to 2 weeks
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is Topical CBD Effective in Treating Thumb Joint Arthritis
Baseline characteristics by cohort
| Measure |
Start With CBD
n=10 Participants
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
|
Start With Control (Shea Butter)
n=8 Participants
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
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
63.6 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-hispanic
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Subjects served as their own control so 18 people completed each intervention.
Grip strength, kg.
Outcome measures
| Measure |
CBD Group
n=18 Participants
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
|
Shea Butter Group
n=18 Participants
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
|
|---|---|---|
|
Change in Hand Strength During Intervention and at Follow-up.
|
24 KG
Standard Deviation 2.3
|
23 KG
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Subjects served as their own control so 18 people completed each intervention.
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.
Outcome measures
| Measure |
CBD Group
n=18 Participants
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
|
Shea Butter Group
n=18 Participants
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
|
|---|---|---|
|
Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up.
|
4.2 score on a survey
Standard Deviation 1.8
|
38 score on a survey
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Subjects served as their own control so 18 people completed each intervention.
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.
Outcome measures
| Measure |
CBD Group
n=18 Participants
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
|
Shea Butter Group
n=18 Participants
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
|
|---|---|---|
|
Change in Kapandji Score
|
9 score on a scale
Standard Deviation 0.2
|
9 score on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Subjects served as their own control so 18 people completed each intervention.
Metacarpal phalangeal (MP) range of motion, passive extension.
Outcome measures
| Measure |
CBD Group
n=18 Participants
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
|
Shea Butter Group
n=18 Participants
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
|
|---|---|---|
|
Change in Hand Range of Motion
|
-7.5 degrees
Standard Deviation 3.9
|
-3 degrees
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Subjects served as their own control so 18 people completed each intervention.
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.
Outcome measures
| Measure |
CBD Group
n=18 Participants
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
|
Shea Butter Group
n=18 Participants
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
|
|---|---|---|
|
Rate of Side Effects Using Novel CBD Cream.
|
0 Participants
|
0 Participants
|
Adverse Events
CBD Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Shea Butter Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place