Assessment of Nociceptive Processing Among Patients With Temporo-mandibular Disorders

NCT04086732 | Completed

• 1 other identifier: HFS Mandibular
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This case control study will investigate the physiological effect of nociceptive input in individuals with temporomandibular disorders. To do so, the investigators will compare the development of secondary hyperalgesia following high frequency electrical stimulation (HFS) of skin nociceptors in the forearms for up to 48 hours in individuals with chronic TMD (as a main complain) and in healthy controls. Furthermore, the investigators will evaluate the association between the response to HFS and various factors, such as demographic, psychosocial and pain-related clinical factors.

Conditions

Temporomandibular Disorder

Keywords

central sensitization; high-frequency stimulation

Outcome Measures

Primary Outcomes (1)

• The extent of secondary hyperalgesia on the forearm in the proximo-distal direction 45 minutes after HFS

  The area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 millinewton pinprick probe. Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure

  After HFS and the assessment of pain resulting from pinprick stimulation and allodynia (time 7). This outcome is taken at day 1 at time 7.

Secondary Outcomes (21)

• Age

  During the initial evaluation (time 1). This outcome is taken at day 1 at time 1.

• Weight

  At baseline (time 1). This outcome is taken at day 1 at time 1.

• Height

  At baseline (time 1). This outcome is taken at day 1 at time 1.

• The TMD diagnosis according to the diagnostic criteria for temporomandibular disorders (DC/TMD)

  At baseline (time 1). This outcome is taken at day 1 at time 1.

• Graded chronic pain scale

  At baseline (time 1) and 6 months after the initial assessment (time 10). This outcome is taken at day 1 at time 1 and day 180 at time 10.

Study Arms (2)

Temporomandibular disorder

EXPERIMENTAL

Procedure: High-frequency electrical stimulation

Healthy control

EXPERIMENTAL

Procedure: High-frequency electrical stimulation

Interventions

High-frequency electrical stimulation PROCEDURE

High-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be milliampere. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin).

Healthy control; Temporomandibular disorder

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged between 18 and 50 years.
• BMI between 17 and 30.
• Ability to provide written informed consent.

You may not qualify if:

• Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
• Evidence of skin alteration on the volar forearms that may interfere with HFS.
• Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
• Any painful musculoskeletal disorder.
• Lack of dental check-ups during the last 12 months.
• Females aged between 18 and 50 years.
• BMI between 17 and 30.
• Ability to provide written informed consent.
• Chronic TMD (for at least 3 months) as a main complain (according to the DC/TMD), with an average of at least 3/10 on a pain numerical rating scale during the past month in the orofacial region.
• Evidence of psychiatric/inflammatory/neurological or metabolic comorbidities on direct questioning as this study is meant to focus on musculoskeletal disorders.
• Evidence of skin alteration on the volar forearms that may interfere with HFS.
• Any substance abuse, or the use of antidepressant or neuroleptic medication as these may interfere with the psychophysical examination.
• Lack of dental check-ups during the last 12 months

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires St-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 12, 2019
• Study Start: January 11, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)