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临床试验/NCT06306833
NCT06306833招募中不适用

Psychophysiological Biomarkers to Assess the Effectiveness of Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain

Amaila Fazal [afazal]2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Pain Intensity and interference

研究概览

简要总结

The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run.

详细描述

Chronic low back pain (CLBP) is a multifaceted condition with a range of adversative sequelae including mental and physical disability, social issues, and increased healthcare utilization. CLBP is one of the leading worldwide health problems however it has a benign nature. It is now accountable for more years lived with disability (YLDs) than any other chronic health problem. Chronic low back pain caused 72 million YLDs in 2013 approximately which is 1.5 times greater than that of depression and twice as high as that of diabetes. Further, in 2013, around 615 million individuals globally were affected by disabling chronic low back pain. Additionally, chronic low back pain and its accompanying disability also have a major economic burden on the country. According to an estimation, between 5 to 10% of low back pain cases will develop chronic low back pain (CLBP), which is ultimately accountable for the increased cost of treatment, a high number of sick leaves, and individual suffering and also one of the leading cause for individuals seeking health care services. Disparagingly, the issue of CLBP is not well understood in developing countries like Pakistan, Sri Lanka, India, and Bangladesh, which are in the process of development and experiencing economic development and a double burden of diseases. The chronic low back pain prevalence in Southeast Asian countries is reported to be very high, for instance much higher than that reported in the Western world. The prevalence of CLBP in Bangladesh is 64% followed by Pakistan which has a 40% prevalence rate and Sri Lanka and India 36% and 19%, respectively. Previous research studies have focused on the documentation of factors that are termed "yellow flags" which induce, aggravate, and enhance pain and disability in chronic low back pain patients. Psychological and social factors are considered important contributing factors in the bio-psychosocial approach for chronic low back pain management and its relationship with disability. Moreover, this study is in line with the United Nations' Sustainable Developmental Goals (UN-SDG) 2030 plan; Goal 3.d i.e. to "strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks". Thus, this study protocol will be a randomized controlled trial that is specifically designed to compare the biofeedback surface EMG effectiveness for chronic low back pain in the Pakistani population.

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)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who constantly experience low back pain for the last three months.
  • Individuals who seek care from healthcare provider due to low back pain
  • Individuals with average pain intensity, were assessed using the Brief Pain Inventory (BPI) over the past week ≥ 2 on a 0-10 scale.
  • Individuals with an average Oswestry Disability Index (ODI) score ≥
  • Individuals with State-Trait Anxiety Inventory (STAI) score ≥ 20.

排除标准

  • Age below or above 25 and 75 years, respectively.
  • Females who are pregnant, lactating, or that they anticipate becoming pregnant in the next 3-6 months will be excluded.
  • Individuals having any diagnosed chronic disease.
  • Individuals having any diagnosed neurological disorder including Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
  • Individuals having any diagnosed motor disorder or had pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
  • Individuals with an active cancer
  • Blind individuals
  • Individuals having a body mass index greater than 35 kg/m2
  • Individuals with clinical depression, that is having a score of 24 or higher on the Center for Epidemiology Depression Scale.
  • Individuals who have used narcotics or muscle relaxants within 30 days before study enrollment.

结局指标

主要结局

Pain Intensity and interference

时间窗: 3 Months

The Brief Pain Inventory (BPI) will be used to assess the severity of chronic low back pain and its impact on lower back functioning. Participants will rate the pain severity and the degree of interference. Using a 0-10 scale, where 0-4 corresponds to mild pain, 5-6 corresponds to moderate pain, and 7-10 corresponds to severe pain

Lower back pain related Disability

时间窗: 3 Months

The Oswestry Disability Index (ODI) will be used to categorize the degree of disability in CLBP patients. Each section is scored on a 0-5 scale, where 5 represents the greatest disability. The index is calculated by dividing the summed score and expressed as a percentage. Where, 0 - 20 indicates mild disability, 20 - 40% indicates moderate disability, 40 - 60% indicates severe disability, 60 - 80% indicates disabling, and 80 - 100% indicates bedridden or functional impairment.

Quality of Life with chronic low back pain

时间窗: 3 Months

The quality of life questionnaire will be used to assess the patient's perspective of their life quality. The score can range from 6-112. A higher score indicates a higher quality of life, where, a score of 90 is the average for a healthy population

Pain and Disability-related Anxiety

时间窗: 3 Months

The State-Trait Anxiety Inventory-STAI will be used for anxiety screening. It is a 20-item scale with a score range of 20-80, where higher score indicate higher levels of anxiety symptoms

次要结局

  • Cortisol(3 Months)
  • Beta Endorphins(3 Months)
  • Substance P(3 Months)

研究者

发起方
Amaila Fazal [afazal]
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amaila Fazal [afazal]

Research Associate

Advanced Education & Research Center

研究点 (2)

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