Comparative Analysis of the Effectiveness and Comfort of Different Dry Needling Techniques in the Treatment of Orofacial Myofascial Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from Baseline in Self-Reported Orofacial Pain Intensity
研究概览
简要总结
This study aims to compare the clinical effectiveness and individual comfort of three distinct dry needling techniques (dynamic, static, and hybrid) for managing orofacial myofascial pain. Myofascial pain is a highly prevalent manifestation of temporomandibular disorders (TMD), characterized by painful trigger points in the masticatory muscles, such as the masseter and temporalis, which cause pain, muscle tenderness, and jaw movement limitations. While dry needling is widely recognized as an effective minimally invasive therapy to deactivate these trigger points, there is still a lack of consensus in scientific literature regarding the standardization of application protocols.
To address this gap, this randomized, triple-blind, parallel-group clinical trial will enroll 45 individuals diagnosed with myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Participants will be randomly allocated into three equal groups (15 individuals per group): Group 1 will receive dynamic dry needling (fanning technique); Group 2 will receive static dry needling (needle kept in situ for 10 minutes); and Group 3 will receive a hybrid approach (combining an initial static period followed by dynamic manipulation).
The primary outcome will evaluate changes in self-reported pain intensity using a Visual Analog Scale (VAS) from baseline to 7 days post-intervention. Secondary outcomes will assess changes in pressure pain thresholds (PPT) via digital algometry, mandibular range of motion via digital caliper measurements, and the subjective perception of comfort and acceptability of each technique. Evaluations will be conducted at baseline, immediately post-intervention, at 7 days, and at 15 days of follow-up. The findings are expected to contribute to the standardization of more effective and comfortable clinical protocols for managing orofacial pain.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Myofascial Pain (with or without referred pain) in the masseter and/or temporalis muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
- •Presence of at least one active trigger point in a taut band reproducing the chief complaint
- •Baseline pain intensity ≥ 2 on the VAS in the last two weeks
- •Confirmed pressure pain threshold (PPT ≤ 1.5 kg/cm²)
- •Signed informed consent form
排除标准
- •TMD treatment in the last 3 months (physical therapy, needling, laser therapy) or Botulinum Toxin injection in the orofacial region within 12 months
- •Continuous systemic use of analgesics, anti-inflammatories, or muscle relaxants
- •Diagnosis of fibromyalgia, systemic rheumatic diseases, neurological disorders, or neuropathic pain
- •Needle phobia (belonephobia), coagulation disorders, or use of anticoagulant drugs
- •Active skin or odontogenic infections in the application area
- •History of recent facial trauma or orthognathic/joint surgery
- •Pregnancy
研究组 & 干预措施
Dynamic Dry Needling
Individuals will receive fast-in and fast-out needle manipulation (Hong's technique) in a fanning shape inside the trigger point of the masseter and/or temporalis muscles. The procedure continues until local twitch responses cease or the individual's tolerance limit is reached.
干预措施: Dry needling (Procedure)
Static Dry Needling
The needle will be inserted directly into the core of the active trigger point in the masseter and/or temporalis muscles and will remain completely static in situ for 10 minutes, focusing on neurophysiological modulation without further mechanical stimulation.
干预措施: Dry needling (Procedure)
Hybrid Dry Needling
A combination protocol where the needle is inserted into the trigger point and kept static for 5 minutes for initial desensitization, followed by a brief period of dynamic fanning manipulation (fast-in and fast-out).
干预措施: Dry needling (Procedure)
结局指标
主要结局
Change from Baseline in Self-Reported Orofacial Pain Intensity
时间窗: Baseline (T0) and 7 days post-intervention (T2). (This is the primary endpoint to identify mid-term clinical relevance).
Evaluated using a 100 mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates the "worst imaginable pain". The individual marks their current pain perception on the scale. The score is determined by measuring the distance from the left anchor to the individual's mark.
次要结局
- Change from Baseline in Pressure Pain Threshold (PPT)(Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).)
- Change from Baseline in Mandibular Range of Motion(Baseline (T0), 7 days post-intervention (T2), and 15 days post-intervention (T3).)
研究者
Flávio Magno Gonçalves
Professor
Tuiuti University of Paraná