A Split Mouth Study to Evaluate Transcutaneous Electrical Nerve Stimulation as an Effective Non-pharmacological Approach in Managing Pain During Initial Orthodontic Treatment - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain will be measured after intervention at visual analogue scale
研究概览
简要总结
Orthodontic treatment often causes pain during the initial alignment stage which can lead to discomfort, reduced compliance, and slower treatment progress.
Potential Solution: Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, non-pharmacological approach that uses mild electrical currents to stimulate nerves and potentially reduce pain.
This study uses a split-mouth design, with each patient acting as their own control. One side of their mouth receives the TENS therapy, while the other receives a placebo treatment (minimum current below the therapeutic level). This allows for a direct comparison of TENS effectiveness without the influence of individual pain variations.
Research Goal: The study aims to determine whether TENS can effectively manage pain during initial orthodontic treatment. This would offer a safe and natural alternative to pain medications, potentially improving patient comfort and treatment outcomes.
详细描述
Goal:
This study aims to investigate the potential of Transcutaneous Electrical Nerve Stimulation (TENS) as a safe and effective non-pharmacological approach for managing pain during the initial stages of orthodontic treatment.
The study will compare the pain-relieving effect of TENS therapy with a placebo treatment in a split-mouth design. This means that each participant will act as their own control, with one side of their mouth receiving TENS and the other side receiving a placebo treatment that mimics the TENS device but delivers minimal electrical current.
The study will involve individuals aged 15-57 years old who are undergoing initial orthodontic treatment with alignment archwires. Participants should have good oral hygiene and no contraindications to TENS therapy, such as epilepsy, cardiac arrhythmias, or pacemakers.
The primary question the study aims to answer is: Can TENS be used as an effective alternative to pain medication for managing pain during the initial stages of orthodontic treatment? Participants will undergo a thorough clinical examination and provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
split-mouth study design interventional or placebo control side will be selected randomly through sealed envelope by an independent researcher not involved in the study .
入排标准
- 年龄范围
- 18 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both male and female patients Age 18-57 years Good oral hygiene Patients in alignment and levelling stage Patients how have not taken any pain medication in the past 24 hours
排除标准
- •Patients with history of epilepsy Patients with cardia arrhythmias and pacemaker Pregnant patients
研究组 & 干预措施
TENS group
Participants in this arm will receive two 5-minute sessions of TENS therapy with a 2-minute break in between.
Self-adhesive electrode pads will be placed on the designated cheek as determined by randomization.
The TENS device will be set at intensity that is comfortable for the participant.
The device will deliver electrical pulses through the electrodes to stimulate sensory nerves and potentially reduce pain.
Participants will receive this TENS therapy application immediately after the initial placement of the alignment archwire Both groups will be instructed to mark their pain levels on a visual analog scale (VAS) at 0, 6, 24, and 48 hours after the initial archwire placement.
干预措施: TENS (Device)
Placebo/Control group
Participants in this arm will receive a similar treatment that mimics the TENS application but with minimal current to maintain participant blinding.
Similar to the TENS group, self-adhesive electrode pads will be placed on the designated cheek.
The placebo device will be set at a very low intensity that only feels like a slight tingling sensation.
This sham treatment serves as a control, allowing comparison of any pain reduction to the effects of real TENS therapy.Participants will receive this placebo treatment application on the same schedule as the TENS group - immediately after archwire placement
干预措施: TENS (Device)
结局指标
主要结局
Pain will be measured after intervention at visual analogue scale
时间窗: pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours
pateint after giving TENS treatment will be asked to measure their pain score for right and left side on visual analogue scale
次要结局
未报告次要终点
研究者
Shoaib Rahim
Assistant professor
Foundation University Islamabad