Effects of Cognitive Functional Therapy Versus Kinetic Control Training on Pain, Disability, Movement Control in Patients With Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Pain Intensity Measured by Numeric Pain Rating Scale
研究概览
简要总结
The goal of this clinical trial is to compare Cognitive Functional Therapy (CFT) with Kinetic Control Training (KCT) in participants with non-specific low back pain. The study wants to see which approach helps lower pain, reduce disability and improve movement control. The main questions it aims to answer is
- Is there difference between Cognitive Functional Therapy and Kinetic control training on pain intensity, disability and movement control in participants with Non Specific Low Back Pain?
- Is there difference between Cognitive Functional Therapy and Kinetic control training on pain catastrophizing and self-efficacy in participants with Non Specific Low Back Pain? Researcher will compare the both CFT and KCT group to see if one treatment is superior to other in treating participants with non-specific back pain.
Participants will
- Attend treatment sessions based on the group they are placed in.
- Take session three times each week for eight weeks.
- They will be asked short questions about their pain, daily activity, and movement throughout the study.
详细描述
Low back pain (LBP) has the highest prevalence globally among musculoskeletal disorders, affecting around 619 million people in 2020. It is projected that the number of cases will skyrocket to 843 million by 2050. LBP is defined as the localized pain below the costal margin and above the inferior gluteal folds. It is commonly categorized as specific and non-specific low back pain. Non-Specific Low Back Pain (NSLBP) accounts for nearly 90% of all cases.
NSLBP is multifactorial and mostly new cases recover within a short time but the condition frequently recurs and may become persistent. An extensive review regarding the management of LBP has stated that exercise plays a fundamental role in treating patients with NSLBP. However, the results regarding the appropriate type of exercise are the subject of controversy. Over the past decades, researchers have advised a variety of exercises. However, despite applying various treatment approaches, conservative treatment for NSLBP yields small effect sizes.
Cognitive Functional Therapy (CFT) is developed by Peter O'Sullivan, to address the multidimensional nature of non-specific low back pain. The CFT is structured into three phases: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. Rather than adopting a one size fits all approach, CFT provides clinicians with the opportunity to explore the multidimensional nature of NSLBP.
Kinetic Control Training (KCT) developed by Comerford, is a clinical framework focused on the assessment and correction of uncontrolled movement. KCT utilizes a three-stage retraining process: (1) cognitive facilitation of correct muscle activation; (2) integration into low-load, non-provocative tasks; and (3) progression to complex, functional movements under load and fatigue.
Despite the promising evidence supporting both CFT and KCT, a clear comparative study of their effectiveness in addressing NSLBP is lacking. Most existing studies have focused on one technique or compared it with general exercise. This study seeks to address this gap by evaluating and comparing these two approaches.
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
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes
- •Aged between 19 to 39
- •Patients who score 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ) at the time of screening
- •Patients who will have Non-Specific Chronic Low Back pain for at least 3 months duration
排除标准
- •If the primary pain area is not the lumbar spine.
- •If leg pain is the primary problem.
- •If patient have inflammatory disease.
- •If patient have progressive neurological disease.
- •If patient have red flag disorders (malignancy/cancer, traumas such as fracture).
- •Pregnant females.
研究组 & 干预措施
Cognitive Functional Therapy
干预措施: Cognitive Functional Therapy (Behavioral)
Kinetic Control Training
干预措施: Kinetic Control Training (Other)
结局指标
主要结局
Pain Intensity Measured by Numeric Pain Rating Scale
时间窗: It will be measured at baseline, 4 weeks and at 8 weeks.
Pain intensity will be measured with an 11 point Numeric Pain Rating Scale that is measured from 0 to 10. 0 is no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 is the most severe pain imaginable.
Disability measured by Roland Morris Disability Questionnaire
时间窗: It will be measured at baseline, 4 weeks and 8 weeks
Disability will be measured by Roland Morris Disability Questionnaire (RMDQ). The RMDQ is a valid and reliable tool for estimating the level of disability in Low Back Pain patients. It is composed of 24 questions that are to be answered by the patients with answers of either 'Yes' or 'No'. The variation of the total score may range from a score of 0 (no disability) to a score of 24 (maximum disability).
Lumbar Motor Control measured by the Luomajoki Motor Control Test Battery
时间窗: baseline, 4 week and 8 week
To evaluate lumbar motor control, the Luomajoki Motor Control Test Battery is employed. This battery includes six individual tests that examine movement control in various positions such as standing, sitting, quadruped, and prone. Each test is scored either 0 or 1, with a total score of 3 or higher indicates impaired motor control
Pain Intensity Measured by Numeric Pain Rating Scale
时间窗: It will be measured at baseline, 4 weeks and at 8 weeks.
Pain intensity will be measured with an 11 point Numeric Pain Rating Scale that is measured from 0 to 10. 0 is no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 is the most severe pain imaginable.
Disability measured by Roland Morris Disability Questionnaire
时间窗: It will be measured at baseline, 4 weeks and 8 weeks
Disability will be measured by Roland Morris Disability Questionnaire (RMDQ). The RMDQ is a valid and reliable tool for estimating the level of disability in Low Back Pain patients. It is composed of 24 questions that are to be answered by the patients with answers of either 'Yes' or 'No'. The variation of the total score may range from a score of 0 (no disability) to a score of 24 (maximum disability).
Lumbar Motor Control measured by the Luomajoki Motor Control Test Battery
时间窗: baseline, 4 week and 8 week
To evaluate lumbar motor control, the Luomajoki Motor Control Test Battery is employed. This battery includes six individual tests that examine movement control in various positions such as standing, sitting, quadruped, and prone. Each test is scored either 0 or 1, with a total score of 3 or higher indicates impaired motor control
次要结局
- Catastrophizing pain will be measured by Pain Catastrophizing Scale.(baseline, 4 weeks and 8 weeks)
- Self-efficacy will be measured by Pain Self Efficacy Scale(Baseline, 4 weeks and 8 weeks)
- Catastrophizing pain will be measured by Pain Catastrophizing Scale.(baseline, 4 weeks and 8 weeks)
- Self-efficacy will be measured by Pain Self Efficacy Scale(Baseline, 4 weeks and 8 weeks)
研究者
Umber Nawaz
Assistant Professor
Lahore University of Biological and Applied Sciences