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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003365-34 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiologic saline | Placebo Comparator | Sodium chloride 9 mg/ml liquid for parental use |
|
| Methylprednisolone | Experimental | Depo-Medrol 40 mg/ml, single dose, injection, intra-articular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 1 ml single dose Intra-articular Depo-Medrol 40 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Instrument measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Göran Isacsson, DDS | Orofacial pain unit, Västmanland Hospital Västerås | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orofacial pain unit, Malar Hospital Eskilstuna | Eskilstuna | Södermanland County | 631 88 | Sweden | ||
| Dental specialist clinic Kaniken |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2019 | |
| Reset | Jul 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2019 | Jul 19, 2019 |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Physiologic saline | Drug | 1 ml intra-articular placebo |
|
|
JFLS GCPS PHQ-9 PGIC
| 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?" | 4 weeks |
| Uppsala |
| Uppland |
| 75148 |
| Sweden |
| Specialist clinic Stomatognathic physiology | Gothenburg | VastraGotaland | 40233 | Sweden |
| Specialist center | Uddevalla | VastraGotaland | 45180 | Sweden |
| Orofacial pain unit, Västmanland Hospital Västerås | Västerås | Västmanland County | 72185 | Sweden |
| Orofacial pain unit, Dental Specialist Education Center | Örebro | 70111 | Sweden |
| Orofacial pain unit Eastman Institute | Stockholm | 113 24 | Sweden |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |