跳至主要内容
临床试验/CTRI/2024/11/077354
CTRI/2024/11/077354招募中不适用

Effectiveness of different frequency of interferential therapy on reducing pain score among low back pain patients

Summer Research Founder Chancellor1 个研究点 分布在 1 个国家入组 120 人开始时间: 2024年12月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Visual Analouge Scale base line

研究概览

简要总结

BACKGROUND: Interferential Therapy (IFT) is a widely known and practiced modality in outpatient physiotherapy as a mainstay of pain management of low back disorders. Interferential Therapy is the application of two medium-frequency currents to produce a low-frequency effect. It is based on the principle of Interference, because of which beat frequency is produced. Low Back Pain describes a wide range of pain due to Inflammation and degenerative origin that results in functional impairment. As stated previously, IFT being the widely accepted treatment modality for Pain management, its parameters have been scarcely explored and studied for research purposes. In this context, limited literature evidence regarding the parameters for clinical application is available.

OBJECTIVE: To evaluate the effectiveness of IFT by comparing it with chosen parameters and the overall patient satisfaction with the outcome of treatment.

MATERIAL AND METHOD: An Experimental Clinical Trial study design. 120 Subjects will be recruited from the Sri Ramachandra Physical Rehabilitation Centre OPD. Subjects are stratified and randomly assigned to 3 groups: bipolar constant amplitude modulation frequency (AMF), quadripolar constant AMF with vector, and control. 40 patients per group (single blinding) age 25 TO 45 years with LOW BACK pain. The study population comprises

those who have been diagnosed with Low back Disorders. Interferential Therapy shall be delivered to all groups to tolerance intensity and at high AMF. Pain is monitored and measured before and after treatment on all sessions using a Visual Analogue Scale and patient-perceived effect scale. Patients shall follow up for 3 days. Socio-demographic details are also collected along with informed consent. At the end of 3rd day, the patients are asked to fill out a Physical Therapy Patient Satisfaction Questionnaire that indicates their satisfaction following treatment.

ANTICIPATED OUTCOME: i) Frequency 80-100 Hz would be a more effective choice of frequency for Low back pain control. ii) Patients belonging to the intervention group may have more significant satisfaction than patients belonging to the control group. iii) Patients belonging to the intervention group with chosen parameters would have a significant improvement in terms of relief of symptoms. Also, the satisfaction index would be higher among the patients in experimental group than the control group.

研究设计

研究类型
干预性
分配方式
随机
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patient Diagnosed with Low Back Pain .

排除标准

  • Pregnant women, Tumor, Cognitive unstable, Patients with associated neurological problems, Pain Score more than 4 in VAS .

结局指标

主要结局

Visual Analouge Scale base line

时间窗: at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week

次要结局

  • Oswestry Disability Index(at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week)
  • Lumbar Range of Motion(at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week)
  • Lumbar Muscle endurance(at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week)

研究者

发起方
Summer Research Founder Chancellor
申办方类型
Research institution and hospital
责任方
主要研究者
主要研究者

M Vishwa

Sri Ramachandra Institute of Higher Education and Research[Deemed to be university]

研究点 (1)

Loading locations...

标识符

CTRI 编号
CTRI/2024/11/077354

日期

最近更新
(去年)

相似试验