TMJ DisorderNCT04298554
Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
A study testing CBD Oil and Hemp Oil in people with TMJ Disorder and Myofacial Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- TMJ Disorder, Myofacial Pain, TMD
- What is being tested?
- CBD Oil and Hemp Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 29 May 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18-70 years of age
- Ability to give informed consent
- Arthralgia of the temporomandibular joint as defined according to the RDC/TMD criteria (see below chart)[3] and/or Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria (see below chart)[3]
- Baseline pain must be greater than 3/10 as self-reported on the VAS
Who cannot join
- Allergy to study drug
- Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
- Mandibular fracture within last 12 months
- Pregnancy or breast feeding
- Initiation of additional treatment of MPD within the past 1 months
- Baseline pain less than 3/10 as self-reported on the VAS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial.
The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region.
- Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain.
- Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint.
- Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.
Read the detailed description
The United States National Institute of Health Survey in 2001 conducted a self-reported survey of 30,978 people and determined the overall prevalence of temporomandibular joint and muscles disorders to be 4.6%, with 6.3% women and 1.8% men [1]. Temporomandibular joint arthralgia which is often caused by inflammatory joint arthropathy [2] and is commonly seen in conjunction with myofascial pain of the masticatory region. Myofascial pain syndrome is classically characterized by focal areas of exquisite tenderness caused by trigger points. Temporomandibular joint arthralgia and myofascial pain disorder pertaining to the temporomandibular joint region will be defined according to the research diagnostic criteria below [3].
The exact mechanism of action of CBD is not fully understood and several mechanisms of action have been proposed. Studies have indicated that CBD acts on a system in humans called the endocannabinoid system comprised of the CB1 and CB2 receptors. CB receptors were found throughout the human body: CB1 receptors in the brain and CNS and CB2 receptors are found throughout the gut, spleen, liver, heart, kidneys, blood vessels, lymph cells, and reproductive organs. CB1 receptors in the CNS help maintain core functions such as motor activity, pain perception, stress response, and memory. CB2 receptors widely distributed throughout the body in peripheral organs serve as core components of the immune system, muscular system, and cardiovascular system [4]. The endocannabinoid system has physiological and pathophysiological roles in modulation of pain [5]. Petitet et al. (1998) found CBD considerably reduced the receptor activation of a potent classical CB1 receptor agonist. CBD has a very low affinity for both known cannabinoid receptors. However, CBD antagonizes CB1 and CB2 receptor agonists at doses considerably lower than those of CBD needed to activate cannabis receptors [6]. Pertwee et al. (2002) found CBD was also shown to display inverse agonism at the human CB2 receptor, which may be a rational basis for its anti-inflammatory properties [7]. Pertwee (2002) proposes that CBD also functions outside of CB1 and CB2 receptors. An endogenous cannabinoid, anandamide, produced anti-nociception through mechanisms outside of the endocannabinoid system acting on the vanilloid receptors. The vanilloid receptors may regulate the release of inflammatory molecules (substance P) following exposure to noxious stimuli playing a role in the transmission of pain signals [7]. This pathway is well studied in capsaicin (an active component of chili peppers). Capasicin can produce an analgesic effect by desensitizing the TRPV1 receptor (a vanilloid receptor) inhibiting substance P. CBD inhibits the uptake and hydrolysis of the endocannabinoid anandamide, thus increasing its concentration [8, 9]. CBD stimulates the vanilloid receptor type 1 (VR1) with a maximum effect similar in efficacy to that of capsaicin [8] without the side effect of burning sensation. Not all cannabinoid effects can be explained through the CB1 and CB2 receptors and their endogenous ligand, anandamide. Researchers investigated the mechanisms, by which CBD reduces inflammatory and neuropathic pain in animals [10]. They found that the cannabinoid-induced analgesic effect is absent in mice lacking glycine receptors and concluded that this receptor mediates suppression of chronic pain. In other mouse models, CBD binds to the GPR55 receptor, a putative cannabinoid receptor [11]. This effect is involved in the anti-inflammatory action of CBD. In human clinical trials, Blake (2005) assessed the efficacy and safety of cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Sativex consists of a blend of plant extracts which delivers approximately equal amounts of THC and CBD. Statistically significant improvements in pain on movement, pain at rest, and quality of sleep [12]. The rationale for the starting dose is somewhat arbitrary, 600mg/2FL is the most popular with retail customers. It is the highest concentration available with the CBD PURE brand oil which allows study subjects to maximize on the possible benefits of CBD. Since there are little known side effects, the risk of a higher concentration of CBD causing more adverse side effects is minimal.
- Conditions
- TMJ Disorder, Myofacial Pain, TMD
- Being tested
- CBD Oil, Hemp Oil
- Keywords
- CBD, TMJ, TMD
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD OilOther
Also called Cannabinoids
CBD PURE CBD OIL 20mg/1ml concentration
Hemp OilOther
CBD PURE HEMP OIL
| Study group | Role | What they receive |
|---|---|---|
| CBD Oil | Experimental | CBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily Receives: Other: CBD Oil |
| Placebo (hemp oil) | Placebo comparator | CBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily Receives: Other: Hemp Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in pain, as measured by the Visual Analog Scale (VAS)
Scores are measured from 1-100mm VAS. The VAS ranges from 0 to 100 with O indicating no pain and higher scores indicating a greater pain.
Measured: Baseline, 3 weeks, 7 weeks, and 11 weeks
Secondary outcomes (1)
Change in jaw functional limitations as measured by the jaw functional limitation scale.
Scores are measured from 5 (lowest) to 25 (highest). Higher scores reflect better jaw function.
Measured: Baseline, 3 weeks, 7 weeks, and 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start6 Aug 2020
- Primary completion29 May 2022
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Reeve, DMD FACS, Principal investigator, Weill Cornell New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298554
- Sponsor's protocol ID
- 19-07020513
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04298554
- Acronym / sponsor ID
- 19-07020513
- Conditions
- TMJ Disorder, Myofacial Pain, TMD
- Keywords
- CBD, TMJ, TMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 6 Mar 2020 (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.
The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region.
- Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain.
- Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint.
- Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.
Detailed description
The United States National Institute of Health Survey in 2001 conducted a self-reported survey of 30,978 people and determined the overall prevalence of temporomandibular joint and muscles disorders to be 4.6%, with 6.3% women and 1.8% men [1]. Temporomandibular joint arthralgia which is often caused by inflammatory joint arthropathy [2] and is commonly seen in conjunction with myofascial pain of the masticatory region. Myofascial pain syndrome is classically characterized by focal areas of exquisite tenderness caused by trigger points. Temporomandibular joint arthralgia and myofascial pain disorder pertaining to the temporomandibular joint region will be defined according to the research diagnostic criteria below [3].
The exact mechanism of action of CBD is not fully understood and several mechanisms of action have been proposed. Studies have indicated that CBD acts on a system in humans called the endocannabinoid system comprised of the CB1 and CB2 receptors. CB receptors were found throughout the human body: CB1 receptors in the brain and CNS and CB2 receptors are found throughout the gut, spleen, liver, heart, kidneys, blood vessels, lymph cells, and reproductive organs. CB1 receptors in the CNS help maintain core functions such as motor activity, pain perception, stress response, and memory. CB2 receptors widely distributed throughout the body in peripheral organs serve as core components of the immune system, muscular system, and cardiovascular system [4]. The endocannabinoid system has physiological and pathophysiological roles in modulation of pain [5]. Petitet et al. (1998) found CBD considerably reduced the receptor activation of a potent classical CB1 receptor agonist. CBD has a very low affinity for both known cannabinoid receptors. However, CBD antagonizes CB1 and CB2 receptor agonists at doses considerably lower than those of CBD needed to activate cannabis receptors [6]. Pertwee et al. (2002) found CBD was also shown to display inverse agonism at the human CB2 receptor, which may be a rational basis for its anti-inflammatory properties [7]. Pertwee (2002) proposes that CBD also functions outside of CB1 and CB2 receptors. An endogenous cannabinoid, anandamide, produced anti-nociception through mechanisms outside of the endocannabinoid system acting on the vanilloid receptors. The vanilloid receptors may regulate the release of inflammatory molecules (substance P) following exposure to noxious stimuli playing a role in the transmission of pain signals [7]. This pathway is well studied in capsaicin (an active component of chili peppers). Capasicin can produce an analgesic effect by desensitizing the TRPV1 receptor (a vanilloid receptor) inhibiting substance P. CBD inhibits the uptake and hydrolysis of the endocannabinoid anandamide, thus increasing its concentration [8, 9]. CBD stimulates the vanilloid receptor type 1 (VR1) with a maximum effect similar in efficacy to that of capsaicin [8] without the side effect of burning sensation. Not all cannabinoid effects can be explained through the CB1 and CB2 receptors and their endogenous ligand, anandamide. Researchers investigated the mechanisms, by which CBD reduces inflammatory and neuropathic pain in animals [10]. They found that the cannabinoid-induced analgesic effect is absent in mice lacking glycine receptors and concluded that this receptor mediates suppression of chronic pain. In other mouse models, CBD binds to the GPR55 receptor, a putative cannabinoid receptor [11]. This effect is involved in the anti-inflammatory action of CBD. In human clinical trials, Blake (2005) assessed the efficacy and safety of cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Sativex consists of a blend of plant extracts which delivers approximately equal amounts of THC and CBD. Statistically significant improvements in pain on movement, pain at rest, and quality of sleep [12]. The rationale for the starting dose is somewhat arbitrary, 600mg/2FL is the most popular with retail customers. It is the highest concentration available with the CBD PURE brand oil which allows study subjects to maximize on the possible benefits of CBD. Since there are little known side effects, the risk of a higher concentration of CBD causing more adverse side effects is minimal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD Oil | Experimental | Other: CBD OilCBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily |
| Placebo (hemp oil) | Placebo comparator | Other: Hemp OilCBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 18-70 years of age
- Ability to give informed consent
- Arthralgia of the temporomandibular joint as defined according to the RDC/TMD criteria (see below chart)[3] and/or Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria (see below chart)[3]
- Baseline pain must be greater than 3/10 as self-reported on the VAS
Key exclusion criteria (6 listed)
- Allergy to study drug
- Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
- Mandibular fracture within last 12 months
- Pregnancy or breast feeding
- Initiation of additional treatment of MPD within the past 1 months
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 |
|---|---|---|
| CBD OilAlso: CannabinoidsCBD PURE CBD OIL 20mg/1ml concentration | Other | CBD Oil |
| Hemp OilCBD PURE HEMP OIL | Other | Placebo (hemp oil) |
Primary outcome
Change in baseline in pain, as measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 3 weeks, 7 weeks, and 11 weeks
Scores are measured from 1-100mm VAS. The VAS ranges from 0 to 100 with O indicating no pain and higher scores indicating a greater pain.
1 secondary outcome
Change in jaw functional limitations as measured by the jaw functional limitation scale.
Time frame: Baseline, 3 weeks, 7 weeks, and 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for TMJ Disorder
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
Gwendolyn Reeve, DMD FACS principal investigator
Weill Cornell New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD Oil and Hemp Oil in people with TMJ Disorder and Myofacial Pain, run by Weill Medical College of Cornell University 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 6 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: finished, as of the sponsor's last update on 14 Mar 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in baseline in pain, as measured by the Visual Analog Scale (VAS) (time frame: Baseline, 3 weeks, 7 weeks, and 11 weeks). 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 14 Mar 2023.