ArthralgiaPhase 4NCT01995019
Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
A Phase 4 study testing Methylprednisolone and Physiologic saline in people with Arthralgia and TMJ, run by Uppsala University at 7 sites in Sweden.
Trial summary
The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain. The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthralgia, TMJ
- What is being tested?
- Methylprednisolone and Physiologic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 7 sitesSweden
- Study dates
- 10 Dec 2013to 15 Mar 2017
- Phase
- Phase 4
- 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
- age 18 or above
- the diagnosis arthralgia in one TMJ
- understands Swedish both verbally and in written
- signed informed concent
Who cannot join
- TMJ sounds in terms of clicking (crepitation allowed))
- polyarthritis/connective tissue disease
- bilateral TMJ arthralgia
- fibromyalgia or other generalized pain
- ongoing infection
- ongoing dental treatment
Show all 19Show fewer
- intra-articular corticosteroid injection of a TMJ the past 6 months
- previous surgery of the affected TMJ
- complex psychiatric/psychologic status
- institutionalized living including prisoners
- staff at the investigational clinic
- hypersensitive to local anesthetics
- hypersensitive to methylprednisolone
- hemophilia
- methemoglobinemia
- nursing
- compromized health status according to the judgment of the investigator
- concommitant use of the drugs cyclosporine, erythromycin, pentobarbital, itraconazole, ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant
- mentally retarded
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Orofacial pain unit, Malar Hospital Eskilstuna
Eskilstuna, Södermanland County, 631 88
Specialist clinic Stomatognathic physiology
Gothenburg, VastraGotaland, 40233
Orofacial pain unit, Dental Specialist Education Center
Örebro, 70111
Orofacial pain unit Eastman Institute
Stockholm, 113 24
Specialist center
Uddevalla, VastraGotaland, 45180
Dental specialist clinic Kaniken
Uppsala, Uppland, 75148
Orofacial pain unit, Västmanland Hospital Västerås
Västerås, Västmanland County, 72185
About this study
Official title: PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain.
The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia of the TMJ.
Read the detailed description
This is a randomized blinded multicenter controlled study on 64 subjects (18 years or older) with the diagnosis of unilateral arthralgia of the TMJ.
The subject visit the clinic at three occasions; one enrollment visit, one baseline treatment visit and one evaluation visit one month after baseline.
One week after baseline a follow-up telephone call is made with the purpose to track adverse events.
Pain questionaries are completed morning, lunch and dinnertime during three days before treatment, five days after treatment and three days proceeding the evaluation visit.
The study ís planned to commence 10th December 2013 and last patient out 15th January 2015.
- Conditions
- Arthralgia, TMJ
- Being tested
- Methylprednisolone, Physiologic saline
- Keywords
- Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Depo-Medrol 40 mg/ml
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
Physiologic salineDrug
Also called Sham substance
1 ml intra-articular placebo
| Study group | Role | What they receive |
|---|---|---|
| Physiologic saline | Placebo comparator | Sodium chloride 9 mg/ml liquid for parental use Receives: Drug: Methylprednisolone |
| Methylprednisolone | Experimental | Depo-Medrol 40 mg/ml, single dose, injection, intra-articular Receives: Drug: Physiologic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score change at maximal mouth opening
100 mm analog Visual Analog Scale with endpoints "No pain" and "Worst pain imaginable" The intra-individual change of the VAS pain score between baseline and end of study
Measured: 4 weeks
Secondary outcomes (3)
VAS pain score change at jaw rest
100 mm analog Visual Analog Scale with endpoints "No pain" and "Worst pain imaginable" The intra-individual change of the VAS pain score between baseline and end of study
Measured: 4 weeks
Instrument measures
JFLS GCPS PHQ-9 PGIC
Measured: 4 weeks
Adverse events
Spontaneously reported by the subject or observed by the study staff from the baseline visit until the evaluation visit.
Reported by the subject in response to open questioning at visits/phone calls from the baseline visit until the evaluation visit "Have you had any health problems since your last visit/contact?"
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start10 Dec 2013
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by Uppsala 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Göran Isacsson, DDS, Principal investigator, Orofacial pain unit, Västmanland Hospital Västerås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995019
- Sponsor's protocol ID
- Artralgia1
- Other IDs
- 2013-003365-34
- Status last verified
- May 2017
- First submitted
- 20 Nov 2013
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
- ClinicalTrials.gov ID
- NCT01995019
- Acronym / sponsor ID
- Artralgia1
- Conditions
- Arthralgia, TMJ
- Keywords
- Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 10 Dec 2013 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 26 Nov 2013 (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.
The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain.
The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia of the TMJ.
Detailed description
This is a randomized blinded multicenter controlled study on 64 subjects (18 years or older) with the diagnosis of unilateral arthralgia of the TMJ.
The subject visit the clinic at three occasions; one enrollment visit, one baseline treatment visit and one evaluation visit one month after baseline.
One week after baseline a follow-up telephone call is made with the purpose to track adverse events.
Pain questionaries are completed morning, lunch and dinnertime during three days before treatment, five days after treatment and three days proceeding the evaluation visit.
The study ís planned to commence 10th December 2013 and last patient out 15th January 2015.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiologic saline | Placebo comparator | Drug: MethylprednisoloneSodium chloride 9 mg/ml liquid for parental use |
| Methylprednisolone | Experimental | Drug: Physiologic salineDepo-Medrol 40 mg/ml, single dose, injection, intra-articular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or above
- the diagnosis arthralgia in one TMJ
- understands Swedish both verbally and in written
- signed informed concent
Key exclusion criteria (19 listed)
- TMJ sounds in terms of clicking (crepitation allowed))
- polyarthritis/connective tissue disease
- bilateral TMJ arthralgia
- fibromyalgia or other generalized pain
- ongoing infection
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 |
|---|---|---|
| MethylprednisoloneAlso: Depo-Medrol 40 mg/ml1 ml single dose Intra-articular Depo-Medrol 40 mg/ml | Drug | Physiologic saline |
| Physiologic salineAlso: Sham substance1 ml intra-articular placebo | Drug | Methylprednisolone |
Primary outcome
VAS pain score change at maximal mouth opening
Time frame: 4 weeks
100 mm analog Visual Analog Scale with endpoints "No pain" and "Worst pain imaginable" The intra-individual change of the VAS pain score between baseline and end of study
3 secondary outcomes
VAS pain score change at jaw rest
Time frame: 4 weeks
Instrument measures
Time frame: 4 weeks
Adverse events
Time frame: 4 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 19 May 2017.
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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.
Göran Isacsson, DDS principal investigator
Orofacial pain unit, Västmanland Hospital Västerås
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone and Physiologic saline in people with Arthralgia and TMJ, run by Uppsala University at 7 sites in Sweden.
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 19 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
VAS pain score change at maximal mouth opening (time frame: 4 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 19 May 2017.