This study examines if there are therapeutic benefits over injecting dexamethason into the temporomandibular joint after arthrocentesis with patients with ostheoarthritis.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain.
The difference in pain before and after the treatment will be measured using
the Visual Analog Scale (0 100 mm).
In the experimental group the treatment is considered succesful when 90 percent
of the patiënts achieve a 30 percent reduction in pain with jaw movement on the
VAS scale .
In the control group the treatment is considered succesful when 50 percent of
the patiënts achieve a 30 percent reduction in pain with jaw movement on the
VAS scale.
Secondary outcome
Mandibular Function Impairment Questionnaire (MFIQ).
Difference in units before and after the treatment on the MFIQ scale.
The treatment is considered succesfull if there is a minimum reduction of 13
units on the MFIQ scale.
The maximum mouth opening (mm) is measured at each folluw up.
Background summary
Arthrocentesis is described as a intra articular lavage of the
temporomandibular joint wiith a saline solution. Nowadays arthrocentesis is
used as a treatment for degenerative or reumathoid arthritis, capsulitis,
movement impairment, pain, function impairment.
In some cases, corticosteroïds are used as additive therapy after the isotonic
saline solution. Corticosteroids modify the vascular respons against an
infection, inhibit destructive enzymes en slow down the actions of inflammatory
agents. Intra-articular injections are meant to maximise the local defense
mechanism and minimise the negative systemic effects. Corticosteroïden, like
dexamethasone, react with nucleair steroïd receptors to control the synthesis
of mRNA and proteins. This results in change in T- en B- cel function, changes
in amount of cytokines and enzymes, inhibition of fosfolipase A2, resulting in
a reduction of proinflammatory products of arachidonic acid.
The use of corticosteroid remains controversial because of the adverse effects.
Probably, only a short term reduction in pain is achieved, whereas no long term
reduction is likely to occur. Systemic adverse effect are seldom with the use
of locally applied corticosteroïds. A few rapports claim that intra-articular
administered corticosteroids could lead to destruction cartilage, infection and
worsening of the present disease.
Possibly, the additional administering of corticosteroids in artrocentese is
not beneficial, since these products may only cause an initial reduction of the
pain and not lead to curation of the disease and may even worsen it.
Study objective
This study examines if there are therapeutic benefits over injecting
dexamethason into the temporomandibular joint after arthrocentesis with
patients with ostheoarthritis.
Study design
A randomised double-blind placebo-controlled trial.
Intervention
Group A receives arthrocentesis, plus lavage with 1,0 ml (concentration 20
mg/ml) dexamethason.
Group B receives arthrocentesis, plus lavage with 1.0 ml placebo solution.
Study burden and risks
There is no extra risk involved for the patients, since the therapy under
research is the standard therapy. After arthrocentesis there is always an extra
lavage of the joint with dexamethason.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Initial therapy not succesful; splint-therapy, soft food diet, NSAID's, physiotherapy .
Local anesthetics gives pain relief.
Exclusion criteria
Ankylosis
Rheumatoid arthritis
Underwent open jaw surgery in the past
Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005769-20-NL |
| CCMO | NL14439.042.06 |