Temporomandibular Joint DisordersPhase 2/3NCT01706172
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
A Phase 2/3 study testing Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine in people with Temporomandibular Joint Disorders, run by Chisel Peak Medical Clinic at 1 site in Canada.
Trial summary
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 2016
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 3 month history of :
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Who cannot join
- Any potential acute dental issue
- Rheumatic inflammatory disease
- Chronic intake of NSAIDs or corticosteroids.
- Pain in other body location worse than jaw pain
- Pain 10/10 in other body location.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.
Read the detailed description
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intra-articular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Injection of 20% dextrose/ 0.2% lidocaine, Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
- Keywords
- TMD, temporomandibular, dextrose, prolotherapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 20% dextrose/ 0.2% lidocaineOther
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
Injection of 1 ml of 0.8 Sterile water /0.2% lidocaineOther
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Dextrose 20 % Injection | Active comparator | Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint Receives: Other: Injection of 20% dextrose/ 0.2% lidocaine |
| Sterile Water Injection | Active comparator | Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint Receives: Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
Measured: 3 Months
Secondary outcomes (2)
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises
Measured: 3 Months
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chisel Peak Medical Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- K. Dean Reeves, M.D.
- Responsible party
- Principal investigator, Dr. W Francois Louw, University of British Columbia
- Investigators
- W. Francois Louw, Doctor, Principal investigator, University of British Columbia, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706172
- Sponsor's protocol ID
- TMJS
- Status last verified
- Jan 2017
- First submitted
- 11 Oct 2012
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
PubMed 21757278Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Belanger M. Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. Pain Med. 2012 Aug;13(8):990-9. doi: 10.1111/j.1526-4637.2012.01422.x. Epub 2012 Jul 3.
PubMed 22759069Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
PubMed 22515800Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
PubMed 21969284Louw WF, Reeves KD, Lam SKH, Cheng AL, Rabago D. Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection (Prolotherapy): A Randomized Controlled Trial With Long-term Partial Crossover. Mayo Clin Proc. 2019 May;94(5):820-832. doi: 10.1016/j.mayocp.2018.07.023. Epub 2019 Mar 14.
PubMed 30878157
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT01706172
- Acronym / sponsor ID
- TMJS
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- TMD, temporomandibular, dextrose, prolotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chisel Peak Medical ClinicUniversity, hospital or other
- Collaborators
- K. Dean Reeves, M.D.
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Oct 2012 (estimated)
- 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.
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.
Detailed description
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intra-articular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose 20 % Injection | Active comparator | Other: Injection of 20% dextrose/ 0.2% lidocaineInjecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint |
| Sterile Water Injection | Active comparator | Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaineInjection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Key exclusion criteria (5 listed)
- Any potential acute dental issue
- Rheumatic inflammatory disease
- Chronic intake of NSAIDs or corticosteroids.
- Pain in other body location worse than jaw pain
- Pain 10/10 in other body location.
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 |
|---|---|---|
| Injection of 20% dextrose/ 0.2% lidocaineInjection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine. | Other | Dextrose 20 % Injection |
| Injection of 1 ml of 0.8 Sterile water /0.2% lidocaineInjection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine | Other | Sterile Water Injection |
Primary outcome
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
Time frame: 3 Months
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
2 secondary outcomes
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
Time frame: 3 Months
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Time frame: 1 year
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 2 Feb 2017.
- Background: PubMed 21757278Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
- Background: PubMed 22759069Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Belanger M. Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. Pain Med. 2012 Aug;13(8):990-9. doi: 10.1111/j.1526-4637.2012.01422.x. Epub 2012 Jul 3.
- Background: PubMed 22515800Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
- Background: PubMed 21969284Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
- Derived from this study: PubMed 30878157Louw WF, Reeves KD, Lam SKH, Cheng AL, Rabago D. Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection (Prolotherapy): A Randomized Controlled Trial With Long-term Partial Crossover. Mayo Clin Proc. 2019 May;94(5):820-832. doi: 10.1016/j.mayocp.2018.07.023. Epub 2019 Mar 14.
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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.
W. Francois Louw, Doctor principal investigator
University of British Columbia, Canada
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 Injection of 20% dextrose/ 0.2% lidocaine and Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine in people with Temporomandibular Joint Disorders, run by Chisel Peak Medical Clinic at 1 site in Canada.
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: finished, as of the sponsor's last update on 2 Feb 2017. 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 Canada. 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 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 from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706172, which also lists 5 linked publications.
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 2 Feb 2017.