Evaluation of the Efficacy of Neuromodulation in the Control of Chronic Orofacial Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Intensity Assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
Chronic orofacial pain significantly affects patients' quality of life, compromising essential functions such as chewing and speech. Although conventional treatments are available, many patients do not achieve adequate and lasting relief. This project investigates the effectiveness of neuromodulation techniques, namely transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS), as innovative therapeutic alternatives for the control of chronic orofacial pain.
The study will be conducted in adult patients diagnosed with orofacial pain. Participants will be divided into two groups: one group will receive active neuromodulation (tDCS or TMS) and the other a sham treatment (placebo). Sessions will take place daily over two weeks. Assessments will include pain intensity, pain pressure threshold, masticatory function, and bite strength, in order to observe any functional changes.
The group undergoing neuromodulation is expected to show a significant reduction in pain levels and improvements in quality of life compared to the placebo group. This study could support the adoption of neuromodulation as a complementary approach in the treatment of chronic orofacial pain, offering an effective and non-invasive alternative for patients who do not respond to conventional treatments.
详细描述
The study will be conducted at the University Clinic of the Egas Moniz School of Health and Science - Department of Orofacial Pain. The objective is to evaluate the effects of electrical and magnetic neuromodulation on different chronic pain conditions using standardized non-invasive brain stimulation protocols and validated clinical and functional assessment instruments.
Sample
Individuals with chronic low back pain (score between 40 and 80 on the Portuguese version of the Oswestry Disability Index) and chronic orofacial pain (score between 40 and 80 on the Portuguese version of the Manchester Orofacial Pain Disability Scale) will be selected.
For each chronic pain condition, 50 individuals will be enrolled and allocated into two groups: a control group and an intervention group.
Inclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcome assessors are blinded to group assignment. Active and sham neuromodulation follow identical procedures, session durations, and device setups to maintain blinding. Stimulation operators administer the assigned condition but do not participate in assessments or data analysis to prevent disclosure of allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Participants between 18 and 75 years old.
- •Diagnosis of Chronic Orofacial Pain: Patients with persistent orofacial pain for more than 3 months, confirmed using DC/TMD or other validated diagnostic criteria.
- •Pain Intensity: Baseline score on the Visual Analogue Scale (VAS) ≥ 4 (moderate to severe pain).
- •Treatment History: Patients who have previously tried at least one conventional treatment (e.g., medication or physiotherapy) with limited or no success.
- •Cognitive Ability: Participants cognitively able to understand the study procedures and provide informed consent.
- •Stable Medication Regimen: Stable chronic pain medication for at least four weeks prior to the intervention.
排除标准
- •Neurological Disorders: History of epilepsy, seizures, or other neurological disorders that contraindicate TMS or tDCS.
- •Implanted Medical Devices: Presence of pacemakers, cochlear implants, or other electronic/metallic devices in the head or neck region.
- •Pregnancy: Pregnant or breastfeeding individuals, due to potential risks.
- •Psychiatric Disorders: Severe psychiatric disorders (e.g., schizophrenia, unstable major depression) that may interfere with study adherence.
- •Substance Abuse: Current or recent history (within the last 6 months) of alcohol or substance abuse.
- •Active Medical Conditions: Active infections or untreated systemic diseases that may interfere with results.
- •TMJ Surgery: History of recent temporomandibular joint surgery or invasive dental procedures (within the last 3 months).
- •Contraindications for TMS/tDCS: Sensitivity, intolerance, or inability to tolerate the neuromodulation device.
- •Participation in Another Study: Simultaneous or recent (within the last 3 months) participation in another clinical trial.
研究组 & 干预措施
Active Neuromodulation
Participants assigned to this arm receive active neuromodulation using either transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS), according to the study protocol. Stimulation parameters follow standardized therapeutic settings, including electrode/coil placement, intensity, and session duration. The intervention is delivered over a 2-week schedule. Active stimulation is designed to modulate cortical excitability and pain-related neural circuits.
干预措施: Active Neuromodulation (tDCS or TMS) (Device)
Sham/Placebo Neuromodulation
Participants in this arm receive sham (placebo) neuromodulation designed to mimic the sensory experience of tDCS or TMS without delivering effective stimulation. For tDCS, the device provides brief ramp-up/ramp-down current; for TMS, a sham coil or tilted coil reproduces sound and scalp sensation without inducing cortical effects. Procedures, duration, and interactions are identical to the active arm to maintain blinding.
干预措施: Sham Neuromodulation (tDCS or TMS) (Device)
结局指标
主要结局
Pain Intensity Assessed by Visual Analogue Scale (VAS)
时间窗: Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention
Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), in which participants rate their average pain intensity by marking a point on a horizontal line anchored by "no pain" (0) and "worst pain imaginable" (10). Higher scores indicate greater pain intensity.
次要结局
- Pain Interference Measured by the Brief Pain Inventory (BPI)(Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention)
- Chronic Pain Severity Assessed by the Graded Chronic Pain Scale (GCPS)(Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention)
- Health-Related Quality of Life Measured by SF-36(Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention)
- Pressure Pain Threshold (PPT)(Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention)
- Orofacial Functional Disability Assessed by the Manchester Orofacial Pain Disability Scale (MOPDS)(Baseline, at the end of the 2-week intervention period (after 10 sessions), and 1 month after completion of the intervention)