Investigation of Different Treatment Approaches in Elderly Individuals with Chronic Nonspecific Low Back Pain: a Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pain Assesment
研究概览
简要总结
Chronic nonspecific low back pain (CNSLBP) is a common issue among the elderly, affecting their physical health, daily activities, sleep quality, and overall quality of life. This study aimed to compare the effects of various interventions, including standard therapy (ST), transcutaneous electrical nerve stimulation (TENS), yoga, kinesiology taping (KT), awareness education, and home exercises on pain, disability, sleep quality, and quality of life in elderly with CNSLBP. In line with the objectives of this randomized controlled trial, the following hypotheses have been formulated:
Hypothesis 1: Standard treatment and transcutaneous electrical nerve stimulation (TENS) have an effect on pain, disability status, sleep, and quality of life in elderly individuals with chronic non-specific low back pain (CNSLBP).
Hypothesis 2: Yoga has an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.
Hypothesis 3: Educational sessions and home exercise programs have an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.
Hypothesis 4: Kinesiology taping and home exercise programs have an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.
The study was conducted at a private physical therapy and rehabilitation center in the Aegean region between July 2024 and November 2024.
Patients were randomly assigned to four different groups. Group 1 (G1): Participants received standard physiotherapy approaches, including therapeutic ultrasound and hot packs, in addition to transcutaneous electrical nerve stimulation (TENS). TENS was applied using two channels with 5x5 cm electrodes placed over the thoracic 12 and sacral 1 regions. Four electrodes were used for 20 minutes with a pulse width of 50-100 µs and a frequency of 60-120 Hz.
Group 2 (G2): Participants engaged in Iyengar yoga sessions that included asanas, pranayama, and mental focus exercises. The sessions lasted 45 minutes and were conducted as group exercises tailored for elderly individuals. Additionally, participants were encouraged to continue yoga exercises on non-session days.
Group 3 (G3): Participants received educational sessions and home exercise programs targeting low back pain. The educational sessions were based on the World Health Organization (WHO) guidelines for low back pain management.
Group 4 (G4): Participants received kinesiology taping and home exercise programs. Kinesiology taping was applied in an I-shaped parallel manner to the quadratus lumborum muscle.
All interventions were administered three times per week for four weeks, totaling 12 sessions.
详细描述
With the rapid advancements in technology and medicine, life expectancy worldwide is steadily increasing, leading to a growing proportion of the elderly population. It is estimated that in the coming years, one in six individuals will be aged 60 or older. This demographic shift necessitates a more focused examination of health issues prevalent among older adults and the development of effective interventions.
The aging process is characterized by a progressive decline in cellular functions, resulting in adverse effects on physical health. One of the most prominent consequences of aging is musculoskeletal disorders. In particular, low back pain (LBP) is among the most prevalent conditions affecting elderly individuals and is directly associated with disability and a decline in quality of life. Notably, a substantial proportion of LBP cases occur without an identifiable underlying pathology and often become chronic, significantly impairing daily activities.
In the coming years, the prevalence of LBP is expected to rise considerably due to the aging population. This condition not only contributes to physical discomfort but also restricts mobility, increases dependency in daily activities, and negatively impacts sleep quality. The coexistence of chronic pain and sleep disturbances further exacerbates the decline in overall well-being among older adults. Consequently, identifying effective treatment strategies specifically targeting elderly individuals has become increasingly critical.
A variety of pharmacological and non-pharmacological approaches are available for managing LBP. However, pharmacological treatments may not always be the optimal solution, as they can pose risks of adverse effects, particularly in older adults. Non-pharmacological interventions, including yoga, electrotherapy, kinesiology taping, educational programs, and home-based exercise regimens, have been explored as alternative treatment modalities. Nevertheless, the existing body of research on these approaches remains limited, and further evidence is required, particularly concerning their efficacy in elderly populations.
This study aims to evaluate the effectiveness of different treatment modalities for elderly individuals suffering from chronic LBP. Various interventions, including standard physical therapy, electrotherapy, yoga, kinesiology taping, home exercise programs, and educational sessions, were compared to determine their effects on pain relief, mobility, sleep quality, and overall quality of life.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 86 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to understand verbal and visual communications
- •Be literate
- •To volunteer for the study
- •Be 65 years of age or older
- •Have Chronic Non-Specific Low Back Pain (CNSLBP)
排除标准
- •Individuals who wish to withdraw from the study
- •Those with spinal infections, radiculopathy, myelopathy, autoimmune diseases, spondylolysis, spondylolisthesis, spinal fractures
- •Cardiovascular or pulmonary diseases that may contraindicate participation."
研究组 & 干预措施
The group that received standard physiotherapy approaches
therapeutic ultrasound, hotpack and TENS (5x5 cm electrodes, applied to the thoracic 12 and sacral 1 regions).
干预措施: Standard physiotherapy approaches (Device)
The group that received yoga interventions
Yoga Group practiced Iyengar yoga asanas, pranayama, and mental focusing components in a group exercise format for 45 minutes.
干预措施: Yoga Exercises (Other)
Kinesiology taping group
In the kinesiology taping technique, tape was applied in an I-shape parallel to the m. quadratus lumborum muscle.
干预措施: Kinesiology taping (Other)
The group that received educational sessions on low back pain
The educational training was based on the WHO's guidelines for back pain.
干预措施: Awareness training for low back pain (Behavioral)
结局指标
主要结局
Pain Assesment
时间窗: 4 weeks
The Visual Analog Scale (VAS) is a commonly used tool in clinical settings to measure subjective characteristics or feelings that cannot be directly measured, such as pain intensity, fatigue, or mood. It typically consists of a straight line, often 10 cm in length, with two endpoints representing extreme levels of the phenomenon being measured. Ends of the scale: The left end (0) usually represents the absence of the characteristic (e.g., "No pain"), and the right end (10) represents the maximum intensity or severity of that characteristic (e.g., "Worst possible pain"). Patient's response: The patient marks a point on the line that represents their perception of the current intensity. The position of the mark is then measured in millimeters or centimeters.Pain: The VAS might be used to assess pain, with one end of the line representing "No pain" and the other representing "Worst pain imaginable."
Disability Assessment
时间窗: 4 weeks
The Oswestry Disability Index (ODI) is a widely used clinical tool designed to measure the degree of disability in patients with low back pain. It assesses the impact of back pain on a person's daily activities, quality of life, and ability to function. The ODI is often used in both clinical practice and research to track changes in disability over time, particularly in individuals with chronic or acute low back pain.The ODI consists of 10 questions, each with 6 possible responses. Each question is related to a specific activity or aspect of life that could be impacted by low back pain. The responses are scored on a scale from 0 (no disability) to 5 (maximum disability), and each section is then given a score that reflects the severity of the disability.
次要结局
- Sleep Quality Assesment(4 weeks)
- Quality of life assessment(4 weeks)
研究者
Kevser Gürsan
Principal Investigator
Uşak University