The aim is to study the effectiveness of arthrocentesis as initial treatment of arthropathy as compared to usual care.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome measure is pain in the TMJ (0 - 100 mm VAS). Furthermore, a
cost-utility analysis will be performed with the QALY (Quality Adjusted Life
Years) as primary outcome measure. The VAS pain scale (0-100) will be used as
primary outcome measure of the cost-effectiveness analysis. QALYs used in the
additionally planned cost-utility analysis will be derived from EQ-5D [EuroQoL
group, 1990] results assessed in the context of the current study.
Secondary outcome
Additional outcome measures are mandibular function (scored as numerical
outcome of validated MFIQ and measurements (mm) of the mandibular range of
motion), Oral Health related quality of life (OHIP), Quality of life in general
(RAND - 36) and bony changes (scored as ordinal variable on panoramic,
transpharyngeal, and transcranial Xrays). Possible confouders may be
psychosocial factors related with chronic pain. These are scored with SCL-90.
Follow-up is at baseline, 3, 12 and 26 weeks (X-rays at baseline and 26 weeks,
psychosocial factors only at baseline).
Background summary
Most articular disorders of the TMJ are degenerative processes, primarily
affecting the articular tissues and eventually leading to destruction of bone
and surrounding structures. Common clinical symptoms are pain, a resticted
mouth opening, joint sounds and problems with chewing food. The disease is
usually treated conservatively with analgesic drugs (NSAIDs), oral appliances
and physical therapy. Conservative treatment for degenerative joint disorders
is often timeconsuming, and has unpredictable successrates. Conservative
treatment does not stop the degenerative process directly and will have its
influence with time. Chronic cases irresponsive to conservative care are
indications for surgical intervention (viz. arthrocentesis (lavage) and
artroscopy). Arthrocentesis is a simplified arthroscopy surgery without the use
of a camera and intra-articular instruments and is rapid, minimally invasive
and safe. Earlier indication of arthrocentesis may cease further degeneration
of the articular tissues and as a matter of fact, it could be cost effective.
Study objective
The aim is to study the effectiveness of arthrocentesis as initial treatment of
arthropathy as compared to usual care.
Study design
Randomized Controlled Trial, RCT; two treatment arms.
Intervention
The aim is to study the effectiveness of arthrocentesis as initial treatment of
arthropathy as compared to usual care.
Study burden and risks
Participation requires patients to return after 3, 12 and 26 weeks.
NSAIDs may cause side effects. The most common side effects are
gastrointestinal. In exceptional cases, kidney problems occur. For both
treatments, no side effects of the two treatments are known.
Participation requires an additional x-ray examination.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- Age over 18 yrs
- Pain in the TMJ
- Complaints that persist after treatment with NSAID (Ibuprofen 3 x 600 mg dd, 2 wks)
- Local anaesthesia of the TMJ yields alleviation of pain complaints
Exclusion criteria
- Bony ankylosis of the TMJ
- Reumatoid arthritis
- History of an open TMJ surgery
- Incompetence to speak the Dutch or English language
- 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 | EUCTR2008-006141-12-NL |
| CCMO | NL24320.042.08 |