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临床试验/NCT07082660
NCT07082660已完成不适用

A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality

Şebnem Nur Alkan2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Lumbar functionality

研究概览

简要总结

This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Outcome measures include pain intensity, lumbar mobility, and functional disability. The study aims to determine whether Tecar therapy provides additional benefits compared to standard care in the early rehabilitation of individuals with lumbar disc herniation.

详细描述

Background Lumbar disc herniation (LDH) is a prevalent musculoskeletal condition that can significantly impair quality of life due to pain and functional limitations. Rehabilitation strategies often include lumbar stabilization exercises, and adjunct electrotherapies such as capacitive-resistive diathermy (TECAR) have gained interest for their potential therapeutic effects.

Purpose This randomized controlled trial aims to evaluate the effects of adding high-frequency capacitive-resistive diathermic current (TECAR) therapy to lumbar stabilization exercises, compared to lumbar stabilization exercises alone, on pain intensity, functional status, and lumbar range of motion in individuals with chronic LDH.

Methods

Thirty participants with chronic LDH (duration >6 months) and no neurological deficits will be randomly assigned to one of two intervention groups:

TECAR + Exercise Group (TEG, n=15): Participants will receive 12 sessions of TECAR therapy (20 minutes, 3 sessions per week) in combination with lumbar stabilization exercises over 4 weeks.

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
Single (Participant)

盲法说明

Participants were masked to their group assignments throughout the intervention period. Both groups received treatment in a similar clinical environment, and the application of TECAR therapy was performed using identical procedures and equipment setup to prevent participants from discerning their allocation. The physiotherapist administering the intervention was aware of group assignments, but outcome assessments were standardized to minimize bias.

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 20-60 years
  • diagnosed with low back pain
  • pain localized between L1 and L5
  • having low back pain lasting for more than 3 months [24].

排除标准

  • having sensory disturbances
  • muscle weakness, or reflex loss identified during motor, sensory, or reflex examinations
  • history of prior lumbal spine surgery or vertebral fractures
  • presence of electronic medical devices such as pacemakers or other implants contraindicated for electrical stimulation or high-frequency diathermy therapy
  • patients officially registered as disabled or receiving social benefits due to low back pain, severe osteoporosis, osteomalacia, malignancy, infectious diseases, or systemic musculoskeletal or rheumatological disorders,
  • pregnancy,
  • cardiovascular conditions preventing exercise, or viscerogenic causes of low back pain

结局指标

主要结局

Lumbar functionality

时间窗: Baseline - 4 weeks

The Oswestry Disability Index (ODI), validated Turkish version, will be used to assess disability related to low back pain. The scale consists of 10 items, each scored from 0 to 5, with a total maximum score of 50. The total score is converted into a percentage using the formula: (total obtained score / maximum possible score) × 100. Scores range from 0% to 100%, where higher scores indicate greater disability. Interpretation categories are as follows: 0%-20% indicates minimal disability; 21%-40% indicates moderate disability; 41%-60% indicates severe disability; 61%-80% indicates crippled; and 81%-100% indicates bed-bound status or possible symptom exaggeration.

次要结局

  • Pain intensity(Baseline - 4 weeks)

研究者

发起方
Şebnem Nur Alkan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Şebnem Nur Alkan

Assistant Professor of Physiotherapy, Atlas University

Atlas University

研究点 (2)

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