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Completed

NCT Number: NCT06577649

Pain and Perceptual Distortion of Face

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.

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Key information

Conditions

Neuropathic Pain Facial Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Orofacial Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dentistry and Oral Health

Aarhus C, 8000, Denmark

About this study

In addition to pain, a curious observation in people with PTNP is that they report that the painful facial area is "swollen" or "feels differently". There are often no clinical signs or physical differences present, hence such self-reported "illusions" may represent a kind of disrupted body image or a "perceptual distortion" of the face and can be speculated to contribute to the maintenance of facial pain. rTMS paradigms are being widely applied in both therapeutic and investigative studies.In this project, the aim is to employ continuous theta-burst stimulation (cTBS), an inhibitory rTMS paradigm, to evaluate its effect on pain perception and PD in people with PTNP.

In this project, people with PTNP (N=9) received a rTMS (50 Hz, 600 pulses for 40s) session/week as intervention for four consecutive weeks at the primary somatosensory cortex (face area) in a "n-of-1" single-blinded randomized controlled cross-over design: (A) active-sham-active-sham or (B) sham-active-sham-active. That is the same participant received both active and sham either in the (A) order or (B). Pain intensity and perceptual distortion (PD) as perceived size changes of the affected face area were measured at baseline, immediately, 60 mins after rTMS in each session and end of the session (a week after rTMS), one and three months after rTMS. Questionnaires on quality of life, jaw function, sleep quality were also assessed. Changes in pain and PD after each intervention were evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Changes in pain intensity

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

    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.

  2. Changes in perceptual distortion

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

    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.

Secondary outcomes

  1. Changes in sleep quality

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

    Measured using the Pittsburgh Sleep Quality Index (PSQI-DK). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  2. Changes in perceived health or health related quality of life

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

    Will be measured using Short Form Survey-36- (SF -36).The instrument includes scales for physical functioning, social functioning, role limitations due to physical or emotional problems, mental health, energy, pain and general health perception. It consists of 36 items. Each item is graded on a scale of 0 to 100, with 0 and 100 serving as the lowest and highest possible scores respectively. A high score corresponds to better health status.

  3. Changes in oral-health related quality of life

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

    Will be measured using Oral Health Impact Profile (OHIP-14) questionnaire .The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better oral health related quality of life (OHRQol).

  4. Changes in functional limitation of the jaw.

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

    Will be measured using jaw functional limitation scale (JFLS-20). The scores range from 1 to 200, with higher scores indicating deteriorating jaw function.

  5. Changes in Psychological Distress

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

    Will be measured using general anxiety disorder (GAD-7) scale. Total score is obtained by adding score for each question (total points). A score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.

  6. Changes in Pain Catastrophizing

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

    Will be measured using the Pain Catastrophizing Scale (PCS-DK). Consists of 13 items. Each item is ranged from 0-4. A high score corresponds to a high degree of pain catastrophizing.

  7. Changes in patients health

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

    Measured using patient health questionnaire-15 (PHQ-15).Each item on the PHQ-15 is rated on a 3-point scale (0=not bothered at all; 1=bothered a little; 2= bothered a. lot). The total score can range from 0 to 30, with higher scores indicating greater severity of somatic symptoms.

  8. Changes in neuropathic pain characteristics

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

    Measured using modified PainDetect questionnaire. The PainDetect questionnaire was slightly modified so that the oral components can also be added. It is scored from 0 to 38, with total scores of less than 12 considered to represent nociceptive pain, 13-18 possible neuropathic pain, and >19 representing >90% likelihood of neuropathic pain.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

From Pain in the Face to Perceptual Distortion: Exploring Mechanisms and Novel Treatment Strategies

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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