Comparison of the Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain in at rest and at chewing
研究概览
简要总结
Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.
详细描述
The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy (PT), and manual therapy (MT). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. Botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. The following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; Visual Analogue Scale (VAS) for pain, maximum painless mouth opening (mm), Oral Health Impact Profile14 (OHIP-14).
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 (Participant, Outcomes Assessor)
盲法说明
Participants were informed only about the type of treatment they received. The results were measured and recorded by another researcher other than the operator.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged 18 to 65 years with complete dentition,
- •Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I or ASA II
- •Patients experiencing moderate to severe pain in the masticatory muscles related to bruxism,
- •Patients who had not previously been treated for bruxism
- •Patients who were diagnosed with bruxism were excluded from the study.
排除标准
- •Presence of temporomandibular joint disorder
- •Known allergy to botulinum toxin
- •Pregnancy
- •Presence of neuromuscular disease
- •Chronic use of muscle relaxant medication within the last 3 months.
研究组 & 干预措施
Group 1
A single session of Botox (Botulinum toxin A) injection was performed. 50 IU was administered bilaterally by intramuscular injection: 30 IU within the masseter muscles and 20 IU within the anterior temporalis muscles.
干预措施: Botulinum toxin (Drug)
Group 2
Dry needling was performed using sterile plastic cylindrical guide needles (25 mm length, 0.25 mm diameter) The needles were inserted 5 mm deep into hypertonic and irritable nodules (trigger points, TrPs) within the masseter and temporalis muscles. Each needle was rotated twice clockwise and then removed after remaining in the TrPs for a total of 20 minutes. The treatment was administered in three sessions, each one week apart.
干预措施: Dry needling (Procedure)
Group 3
Pharmacological treatment was administered by prescribing Miyorel, a combination of methocarbamol (380 mg) and paracetamol (300 mg). The prescribed dosage was two tablets, taken three times daily, for a period of three weeks.
干预措施: Myorel (Drug)
Group 4
Manual therapy was administered, consisting of bilateral facial massage and stretching maneuvers targeting the masseter and temporalis muscles. This treatment was performed for 20 minutes daily over a period of three weeks.
干预措施: Manual therapy (Procedure)
结局指标
主要结局
Pain in at rest and at chewing
时间窗: 12 weeks
Average pain was measured by a scale, named Visual analogue scale.
MMO
时间窗: 12 weeks
Maximum painless mouth opening (in millimeters) was measured by a special ruler.
OHRQoL questionnaire
时间窗: 12 weeks
Oral-health-related quality of life
次要结局
未报告次要终点