Musculoskeletal PainPhase 2/3NCT05170451
Topical CBD for Musculoskeletal Pain
A Phase 2/3 study testing CBD in people with Musculoskeletal Pain, run by University of Virginia at 1 site in United States.
Trial summary
Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older.
- Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
- Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
- Presence of physician-diagnosed musculoskeletal pain in a discrete body region, including bone or joint-related pain, tendon or ligament-related pain, muscle-related pain, or fibromyalgia or physician-diagnosed postoperative pain in a discrete body region.
Who cannot join
- Subject does not speak English.
- Subject is blind.
- Severe cardiac, pulmonary, liver and /or renal disease.
- Coumadin use at time of screening.
- History of mental illness.
- Subjects who are incarcerated.
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- History of drug or substance abuse.
- Pre-existing CBD or hemp-based product usage.
- Subject has had a corticosteroid injection ≤ 3 months prior.
- Subject has had prior surgery for osteoarthritis treatment.
- Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from Screening to the first dose of study medication and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
- Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
- Subjects with ALT/AST >3 times the upper limit of normal at screening.
- Subjects with history of or active depression or suicide ideation based on Columbia-Suicide Severity Rating Scale (C-SSRS).
- Subjects taking prescription or non-prescription medication which are substrates of CYP3A4 (Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, John's wart, Phenobarbital), CYP2C19 (Nootkatone, Ticlopidine, Rifampin, Omeprazole), CYP2C8 (Montelukast, Quercetin, Phenelzine, Rifampin, Clopidogrel) , CYP2C9 (Sulfaphenazole, Tienilic acid, Carbamazepine, Apalutamide, Fluconazole, Celecoxib), CYP1A2 (alpha-Naphthoflavone, Furafylline, Phenytoin, Rifampin, Ritonavir, smoking, Teriflunomide, Ciproflaoxacin, oral contraceptives, Alloprinol) and CYP2B6 (Sertraline, Phencyclidine, Thiotepa, Ticlopidine, Carbamazepine, Efavirenez, Rifampin, Bupropion) within 14 days of the study procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain
Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain.
Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain.
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 CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Read the detailed description
Study Population: 100 subjects presenting with musculoskeletal pain over the age of 18 will be recruited from the University of Virginia from the Hand Center or Primary Care Clinic.
Description of Sites/Facilities Enrolling Participants: This will be a single-site study conducted at the University of Virginia in the Hand Center and the Primary Care Clinic.
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 with a 1-week washout interval between. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe 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 following a 1-week washout period. 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 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 seven (7) weeks from Screening until the final Study Visit.
- Conditions
- Musculoskeletal Pain
- Being tested
- CBD, Control
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Topical CBD 50 mg/ml applied in 1mL amounts twice daily
ControlOther
Also called Shea butter
Topical shea butter applied in 1mL amounts twice daily
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 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 topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. Receives: Drug: CBD; Other: Control |
| Active Comparator: 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 topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. Receives: Drug: CBD; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up.
PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety, where a higher score indicates more pain interference.
Measured: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
Change from baseline in Visual Analog Pain (VAS) Score during intervention and at follow-up.
The VAS score is a unidimensional measure of pain intensity and is a validated, subjective measure for acute and chronic pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line (from 0 to 100), and this rating is then measured from the left edge with higher numbers indicating more pain.
Measured: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
Change from baseline in Single Assessment Numerical Evaluation (SANE)
The SANE score is a validated metric for musculoskeletal pain which can be applied to any joint or region of interest. The patient is asked to rate his/her pain from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.
Measured: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
Secondary outcomes (1)
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.
Measured: [Time Frame: Daily during intervention and 1 week washout, up to 7 weeks.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Terminated due to hurdles of obtaining regulatory approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Crossover
- Model description
- Randomized controlled trial with crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent DeGeorge, University of Virginia
- Investigators
- Brent DeGeorge, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170451
- Sponsor's protocol ID
- HSR200170
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05170451
- Acronym / sponsor ID
- HSR200170
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to hurdles of obtaining regulatory approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain.
Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain.
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 CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
Detailed description
Study Population: 100 subjects presenting with musculoskeletal pain over the age of 18 will be recruited from the University of Virginia from the Hand Center or Primary Care Clinic.
Description of Sites/Facilities Enrolling Participants: This will be a single-site study conducted at the University of Virginia in the Hand Center and the Primary Care Clinic.
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 with a 1-week washout interval between. Patients will apply the topical cream to the affected body region or joint two times daily for 1 hour. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe 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 following a 1-week washout period. 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 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 seven (7) weeks from Screening until the final Study Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with crossover
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Start with CBD | Active comparator | Drug: CBD, Other: ControlThe 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 topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. |
| Active Comparator: Start with control (Shea butter) | Active comparator | Drug: CBD, Other: ControlThe 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 topical cream to the affected body region or joint two times daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older.
- Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
- Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
Key exclusion criteria (15 listed)
- Subject does not speak English.
- Subject is blind.
- Severe cardiac, pulmonary, liver and /or renal disease.
- Coumadin use at time of screening.
- History of mental illness.
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 |
|---|---|---|
| CBDTopical CBD 50 mg/ml applied in 1mL amounts twice daily | Drug | Active Comparator: Start with CBD, Active Comparator: Start with control (Shea butter) |
| ControlAlso: Shea butterTopical shea butter applied in 1mL amounts twice daily | Other | Active Comparator: Start with CBD, Active Comparator: Start with control (Shea butter) |
Primary outcome
Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up.
Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety, where a higher score indicates more pain interference.
Change from baseline in Visual Analog Pain (VAS) Score during intervention and at follow-up.
Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
The VAS score is a unidimensional measure of pain intensity and is a validated, subjective measure for acute and chronic pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line (from 0 to 100), and this rating is then measured from the left edge with higher numbers indicating more pain.
Change from baseline in Single Assessment Numerical Evaluation (SANE)
Time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]
The SANE score is a validated metric for musculoskeletal pain which can be applied to any joint or region of interest. The patient is asked to rate his/her pain from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.
1 secondary outcome
Rate of side effects using novel CBD cream.
Time frame: [Time Frame: Daily during intervention and 1 week washout, up to 7 weeks.]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
Brent DeGeorge, MD, PhD principal investigator
University of Virginia
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 CBD in people with Musculoskeletal Pain, run by University of Virginia 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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 28 Feb 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with change in The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) during intervention and at follow-up. (time frame: [Time Frame: Every 1 week during intervention and 1 week washout, up to 7 weeks.]). The study lists 3 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 28 Feb 2024.