Comparative assessment of efficacy of transcutaneous electrical nerve stimulation versus pharmacotherapy (drug combination of ibuprofen 400 mg, paracetamol 325 mg, chlorzoxazone 250 mg) in the treatment of patients with myofascial pain- A prospective randomised controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Mouth opening (measurement of interincisal distance in mm)
研究概览
简要总结
Myofascial pain is a chronic condition that causes pain in musculoskeletal system. The pain is confined to the
particular area and is typically associated with trigger point in muscle. These trigger points radiate pain to
the affected area when a pressure is applied to them and sometimes with no pressure. The myofascial pain
is characterized by myofascial trigger points and fascial constrictions.
1 A multimodality approach is required
to treat myofascial pain as the condition’s etiology is variable. Various treatment methods include muscle
relaxants, doing jaw stretching exercises, applying ultrasound, TENS, and shortwave diathermy. TENS is a
technique that passes electrical currents across the intact surface of the skin to activate underlying nerves.
This consists of a battery-powered handheld stimulating device which generates pulsed electrical currents
which are delivered through the skin using the electrode pads attached to the skin surface and hence relieve
the pain. Pharmacotherapy including use of combination drugs of NSAIDs and centrally acting muscle
relaxants is one of the treatment modality to relieve the pain.
2 While TENS and Pharmacotherapy are
proven to be effective in relieving muscular pain, there are limited studies pertaining to the treatment of
Myofascial pain that compares the effectiveness of these two modalities.The goal of this study is to compare
the efficacy of these methods in treating Myofascial pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender above 21 years of age.
- •Patients having complaint of masticatory muscle pain.
- •Pain and tenderness in the masticatory muscles on palpation.
- •Patients who have not received any treatment for Myofascial pain, 3 months before the research participation.
排除标准
- •Pain of non-muscular origin (Dental, vascular or neural).
- •Patients presenting with tenderness of temporomandibular joint on palpation.
- •Completely edentulous patients or multiple missing teeth.
- •Patients having epileptic attacks and seizures.
- •Patients of known case of peptic ulcer.
- •Patients mentally retarded or having neuromuscular problem.
- •Patients on pacemakers, cochlear implants or metallic implants (as TENS can alter or adversely affect the function of pacemakers).
- •Patients with cardiac abnormalities (TENS can modify the cardiac impulse).
- •Pregnant patients (TENS is contraindicated because it can cause preterm labour).
- •Patients showing any allergy to lubricating gel used in TENS therapy.
- •Patients with known allergy to chlorzoxazone, ibuprofen, paracetamol will be excluded.
结局指标
主要结局
1. Mouth opening (measurement of interincisal distance in mm)
时间窗: 8 weeks
2. VAS score (using visual analogue scale ranging 0-10)
时间窗: 8 weeks
3. Clicking sound (whether present or absent Y/N)
时间窗: 8 weeks
次要结局
- Adverse effects and recurrence of pain(Once in a month)
研究者
Shah Nida Mujibur Rahman
Government Dental College & Hospital Mumbai