Arthralgia, TMJ
Conditions
Keywords
Arthralgia, Temporomandibular joint, corticosteroids, injection, intra-articular
Brief 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. 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.
Interventions
DRUGMethylprednisolone
1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
1 ml intra-articular placebo
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 or above * the diagnosis arthralgia in one TMJ * understands Swedish both verbally and in written * signed informed concent
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain score change at maximal mouth opening | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain score change at jaw rest | 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 |
| Instrument measures | 4 weeks | JFLS GCPS PHQ-9 PGIC |
| Adverse events | 4 weeks | 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? |
Countries
Sweden
Outcome results
None listed