Pain and Perceptual Distortion of Face

NCT06577649 | Completed

• 1 other identifier: 5771
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic trigeminal neuropathic pain (PTNP) is "a unilateral or bilateral facial or oral pain following and caused by trauma to the trigeminal nerve(s), with other symptoms and/or clinical signs of trigeminal nerve dysfunction, and persisting or recurring for more than 3 months". PTNP may result from a major craniofacial/oral trauma or may be subsequent to relatively minor dental treatments such as teeth extractions, surgeries, root canal treatment. Patients suffering from this condition have a significantly reduced quality of life. Unfortunately, the currently available management modalities are associated with limited success and side effects. Repetitive transcranial magnetic stimulation (rTMS), which is a safe, non-invasive brain stimulation technique has emerged as a potential treatment for chronic pain. In this study, the purpose is to explore the potential of rTMS in treating the persistent neuropathic pain by providing individualized treatment for the sufferers.

Conditions

Neuropathic Pain; Orofacial Pain

Keywords

Repetitive transcranial magnetic stimulation; N-of-1 trials; Perceptual distortion; Post-traumatic trigeminal neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Changes in pain intensity

  Changes in pain intensity from baseline to end of each session measured using self-reported pain dairy using a 0-10 visual analog scale (VAS; 0=no pain and 10=worst pain imaginable). The intervention (active and sham rTMS) were each given in 2 sessions. In total, the participant received 4 sessions of intervention.

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention).

• Changes in perceptual distortion

  Perceptual distortion defined as perceived change in the size/shape of the affected face area will be measured using Numerical Rating Scale ranging from -100% through 0% to +100%, where 0% = no size change, -100% = half the size and +100% = double the size in comparison with non-affected side of face and drawings of the affected area. The changes will be measured from baseline to the end of each session as done for pain intensity.

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention).

Secondary Outcomes (8)

• Changes in sleep quality

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention), 1 and 3 months after intervention.

• Changes in perceived health or health related quality of life

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention), 1 and 3 months after intervention.

• Changes in oral-health related quality of life

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention), 1 and 3 months after intervention.

• Changes in functional limitation of the jaw.

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention), 1 and 3 months after intervention.

• Changes in Psychological Distress

  Prior to intervention at each session (baseline) to the end of that session (7 days after intervention), 1 and 3 months after intervention.

Study Arms (2)

Active group

ACTIVE COMPARATOR

Continuous theta burst stimulation

Device: Active repetitive transcranial magnetic stimulation (rTMS)

Sham group

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation (rTMS)

Device: Sham repetitive transcranial magnetic stimulation (sham rTMS)

Interventions

Active repetitive transcranial magnetic stimulation (rTMS) DEVICE

cTBS (50 Hz, 600 pulses, 80% resting motor threshold) for 40s was applied continuously as active rTMS at the face representation area of primary somatosensory cortex (S1)

Active group

Sham repetitive transcranial magnetic stimulation (sham rTMS) DEVICE

A sham rTMS was applied using the same stimulation parameters as with cTBS, but using a placebo coil, which produced similar sound as the real coil.

Sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent Post-traumatic trigeminal neuropathic pain patients for 6 months or longer
• Stable on analgesic medication

You may not qualify if:

• past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
• Major stroke
• Pregnancy
• Severe organic brain damage

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Dentistry and Oral Health

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• Kothari SF, Dagsdottir LK, Kothari M, Blicher JU, Kumar A, Buchholtz PE, Ashkanian M, Svensson P. Effect of repetitive transcranial magnetic stimulation on altered perception of One's own face. Brain Stimul. 2020 May-Jun;13(3):554-561. doi: 10.1016/j.brs.2020.01.001. Epub 2020 Jan 8.

  PMID: 32289676 RESULT

MeSH Terms

Conditions

Neuralgia; Facial Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simple F Kothari, BDS, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The order of interventions (A) active-sham-active-sham or (B) sham-active-sham-active were randomized using a computer-based random sequence generation program. The allocation was conducted by a nurse not involved in the project and consisted of 12 sealed, opaque and numbered envelopes consisting of information about the treatment order.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "n-of-1" single-blinded randomized controlled cross-over design: (A) active-sham-active-sham or (B) sham-active-sham-active.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 9, 2022
• Primary Completion: May 11, 2024
• Study Completion: July 11, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)