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临床试验/NCT07087548
NCT07087548已完成不适用

Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy

Fenerbahce University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9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
60
试验地点
2
主要终点
Pain intensity (VAS)

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of peloid therapy versus hot pack therapy in adults aged 18-50 with chronic lumbar disc herniation (LDH). The main questions it aims to answer are:

Does peloid therapy reduce pain more effectively than hot pack therapy in patients with chronic LDH?

Does peloid therapy improve functional status, range of motion, and quality of life more than hot pack therapy? Researchers will compare peloid therapy (45°C for 30 minutes, 5 days/week) to hot pack therapy (20 minutes, 5 days/week) to see which treatment offers better clinical outcomes.

Participants will:

Receive either peloid therapy or hot pack therapy for 3 weeks (15 sessions total).

Undergo standard TENS therapy (20 minutes to the lumbar region) after each session.

Complete assessments before and after treatment including:

Pain intensity (Visual Analog Scale - VAS) Functional status (Back Pain Functional Scale - BPFS) Disability level (Oswestry Disability Index - ODI) Quality of life (Short Form-36 - SF-36) Lumbar range of motion and finger-to-floor distance (FFD)

详细描述

Chronic lumbar disc herniation (LDH) is a common spinal disorder that causes pain, functional limitations, and reduced quality of life. Non-invasive physical therapy modalities such as thermotherapy and electrotherapy are frequently used in conservative management. Peloid therapy, a form of thermal mud treatment, has been proposed to exert anti-inflammatory, analgesic, and muscle-relaxing effects. However, limited controlled studies have compared its clinical effectiveness with more commonly used superficial heat modalities like hot packs.

This single-blind, randomized controlled trial was designed to evaluate and compare the effects of peloid therapy and hot pack therapy in adults diagnosed with chronic LDH. A total of 60 participants were randomly allocated into two treatment arms. The peloid group received a localized application of therapeutic mud (peloid) at 45°C for 30 minutes per session, five days per week for three weeks (total 15 sessions). The control group received conventional hot pack therapy for 20 minutes under the same session frequency and duration. Both groups additionally received transcutaneous electrical nerve stimulation (TENS) to the lumbar region following each thermotherapy session.

Outcome measures were recorded before and after the intervention period and included pain intensity (VAS), functional ability (BPFS), disability index (ODI), quality of life (SF-36), lumbar range of motion (flexion, extension, lateral flexion, and rotation), and finger-to-floor distance (FFD). Statistical analysis was performed to assess within-group and between-group changes.

This study provides comparative data on the efficacy of peloid therapy and conventional hot pack application in a homogeneous patient population with chronic LDH and may inform future guidelines on the selection of conservative treatment modalities in physical therapy practice.

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)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals ≥18 years old with CLBP due to LDH lasting more than three months
  • Individuals who showed degeneration and prolapsed herniation on magnetic resonance imaging
  • Individuals were examined by a specialist physician

排除标准

  • having not received physiotherapy for LDH in the last 6 months,
  • severe neurological deficit,
  • osteoporosis,
  • malignancy, inflammatory disease
  • decompensated cardiopulmonary disease,
  • uncontrolled hypertension,
  • those with an important pathology in routine laboratory tests (liver and kidney dysfunction, individuals with thyroid dysfunction, diabetes),
  • vertebral fracture,
  • lumbar listhesis
  • infectious disease at lumbar level,
  • inflammatory lumbar pain,
  • individuals with extruded and sequestered herniation as a result of MRI,
  • those with neurological deficits,
  • communication problems,
  • being allergic to peloid or hotpack
  • pregnant women

结局指标

主要结局

Pain intensity (VAS)

时间窗: Before treatment and after treatment (3rd week).

Pain severity was assessed with the Visual Analog Scale (VAS), which is scored between 0 and 10, and is used to evaluate pain. 0 denotes no pain and 10 denotes unbearably severe pain. Participants were instructed to indicate the level of pain they experienced by marking a point along a 10 cm straight line, and the value found was recorded in cm

Pain intensity (VAS)

时间窗: Before treatment and after treatment (3rd week).

Pain severity was assessed with the Visual Analog Scale (VAS), which is scored between 0 and 10, and is used to evaluate pain. 0 denotes no pain and 10 denotes unbearably severe pain. Participants were instructed to indicate the level of pain they experienced by marking a point along a 10 cm straight line, and the value found was recorded in cm

次要结局

  • Impact of daily activities on a person's life (Oswestry Disability Index)(before treatment and after treatment (3rd week))
  • Assessing functional loss due to low back pain (Back Pain Functional Scale )(before treatment and after treatment (3rd week))
  • Quality of Life (SF-36)(before treatment and after treatment (3rd week))
  • Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation)(before treatment and after treatment (3rd week))
  • Finger-floor distance measurement(before treatment and after treatment (3rd week))
  • Quality of Life (SF-36)(before treatment and after treatment (3rd week))
  • Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation)(before treatment and after treatment (3rd week))
  • Impact of daily activities on a person's life (Oswestry Disability Index)(before treatment and after treatment (3rd week))
  • Assessing functional loss due to low back pain (Back Pain Functional Scale )(before treatment and after treatment (3rd week))
  • Finger-floor distance measurement(before treatment and after treatment (3rd week))

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu AKKURT

assistant professor

Fenerbahce University

研究点 (2)

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