To evaluate the effectiveness of diagnostic arthroscopy in reducing clinical symptoms compared to arthrocentesis under local anesthesia as initial treatment in patients with arthralgia (with or without reduced mobility) of the temporomandibular…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pain during mandibular movement or function using the VAS
Secondary outcome
- Pain perceived by the patient at rest using the VAS
- Maximum Interincisal Opening (MIO; in mm) without perceiving (increased) pain
measured by the clinician
- MIO (in mm) measured by the clinician
- Mandibular range of motion (MROM) measured by the clinician (proal and
lateral movements; in mm)
- Joint blocks and noises (i.e. clicks, crepitation, pops) perceived by patient
in last 3 months (absent/ present)
- Impairment of mandibular function as perceived by patient using the validated
mandibular function impairment questionnaire (MFIQ; 17 items scored on a Likert
scale, with the total score ranging 0-68)
- Cost-effectiveness (using the composite of the primary study outcome variable
*VAS-score during movement or function* and *costs*, and a second
cost-effectiveness analysis using *MFIQ-score* and *costs*)
- Safety (qualitatively and quantitatively measured adverse and serious adverse
events)
Background summary
Degenerative joint disease (DJD) and internal derangement (ID) of the
temporomandibular joint (TMJ) are two closely interrelated, but different
entities. In DJD, secondary inflammatory components account for most of the
symptoms such as joint pain, restricted or deviated mouth opening and joint
clicks and noises. Similarly, due to the close correlation between both
disorders, symptoms in ID may originate from the same inflammatory process.
However, the displacement of the articular disc in ID is not exclusive to a
pathological condition and may occur without any clinical symptoms. Hence when
symptoms do occur, in both DJD and ID, elevated pro-inflammatory cytokines and
degradation products are present in the synovial fluid. The lavage of the joint
with arthrocentesis as initial treatment has therefore shown to be an effective
and cost-efficient way in reducing clinical symptoms of DJD and ID. The more
advanced procedure diagnostic arthroscopy/ single portal arthroscopic lysis and
lavage under localized anesthesia also enables the lavage of the joint, but
additionally allows lysis and localized injections with corticosteroids.
Currently, diagnostic arthroscopy is only performed when arthrocentesis is
proven to be insufficient in reducing clinical symptoms. Indicating diagnostic
arthroscopy as first-line treatment for DJD and ID may prevent further
degeneration of the joint and reduce clinical symptoms more efficiently than
arthrocentesis.
Study objective
To evaluate the effectiveness of diagnostic arthroscopy in reducing clinical
symptoms compared to arthrocentesis under local anesthesia as initial treatment
in patients with arthralgia (with or without reduced mobility) of the
temporomandibular joint.
Study design
Single-center single-blind randomized controlled trial. The study consists of
two arms: one group receives arthrocentesis and the other group diagnostic
arthroscopy.
Intervention
The intervention group receives diagnostic arthroscopy under local anesthesia
and the control group receives arthrocentesis under local anesthesia.
Study burden and risks
Virtually, no additional risks are associated with participation in the study.
The investigational procedure is not associated with an increased risk of
complications in comparison to the control procedure. Both procedures are
furthermore regularly performed in the research healthcare institution (UMCG)
and are part of standard care. The two weeks of NSAID prescription and the
diagnostic intra-articular injection give no additional risks, since these two
steps are also performed when a patient does not choose to participate in the
study. The burden on patients is expressed as a single additional short
questionnaire that needs to be filled in during follow-up moments. Patients
require no additional visits to the hospital, as follow-up moments of the study
are scheduled during standard of care follow-up moments in the outpatient
clinic.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Patients aged 18 years or older.
- Arthralgia of the Temporomandibular joint (TMJ), proven with a diagnostic
intra-articular injection with Ultracain DS Forte.
- TMJ pain still present after two weeks of NSAIDs
- Symptoms presenting unilaterally or bilaterally with at least one TMJ with a
Visual Analog Scale-score < 30 mm during movement or function, after
anesthetizing the contralateral joint.
Exclusion criteria
- Systemic rheumatic disease
- Bony ankylosis of the Temporomandibular Joint (TMJ)
- Congenital or acquired dentofacial deformity
- History of jaw trauma that resulted in jaw or joint pain, bony changes or
mandibular growth restriction
- Prior arthrocentesis, (diagnostic) arthroscopy or open-TMJ surgery
- Psychiatric disorder (as diagnosed by a physician)
- Unwillingness to receive one of the study treatments
- Pregnancy at time of treatment
- Concurrent use of steroids, muscle relaxants or anti-inflammatory drugs other
than the previously prescribed NSAIDs
- Incompetence to speak the Dutch or English language
- Coagulation disorders, diabetes mellitus type I or II, kidney failure, heart
failure, cardiac ischemia, hypertension and history of HIV.
Design
Recruitment
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 |
|---|---|
| CCMO | NL76425.042.21 |
| Other | Wordt geregistreerd na goedkeuring |