Skip to content

DIAGNOSTIC ARTHROSCOPY VERSUS ARTHROCENTESIS AS INITIAL TREATMENT FOR ARTHRALGIA OF THE TEMPOROMANDIBULAR JOINT A mono-center single-blind randomized controlled trial

DIAGNOSTIC ARTHROSCOPY VERSUS ARTHROCENTESIS AS INITIAL TREATMENT FOR ARTHRALGIA OF THE TEMPOROMANDIBULAR JOINT A mono-center single-blind randomized controlled trial - DIAMOND trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50917
Enrollment
140
Registered
2021-08-30
Start date
2022-01-27
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degeneration of the jaw joint disc displacement

Interventions

The intervention group receives diagnostic arthroscopy under local anesthesia and the control group receives arthrocentesis under local anesthesia.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
- Pain during mandibular movement or function using the VAS

Secondary

MeasureTime frame
- 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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)