Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With Lumbosacral Spine Pain Syndrome
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- University of Rzeszow
- 入组人数
- 110
- 主要终点
- Balance
概览
简要总结
The aim of the study is to evaluate the effects of biofeedback-assisted stabilization training and conventional therapy on pain perception, balance, spinal mobility, functional performance, physical activity, stress level, and quality of life in patients with lumbosacral spine pain syndrome treated conservatively. The main research questions the study seeks to answer are as follows: Whether and to what extent the implemented therapeutic program improves balance, spinal mobility, functional performance, physical activity, quality of life, and reduces pain perception and stress levels in patients with lumbosacral spine pain syndrome? Are there differences in therapeutic outcomes depending on the treatment method applied? Are the therapeutic effects maintained three months after completion of the intervention? Researchers will compare two groups: a control group and an experimental group. In the control group, stabilization training will be performed without the use of biofeedback. Participants will undergo clinical and functional assessments (Visual Analogue Scale, Oswestry Disability Index, force platform measurements, etc.). Depending on the group to which participants are randomly assigned, participants will participate in manual therapy, stabilization training, and selected physical therapy modalities. Participants will be continuously supervised by a physician and physiotherapists throughout the 8-week intervention period. Three months after completion of the intervention, participants will undergo a follow-up assessment.
详细描述
The study is interventional, prospective, randomized, and controlled in design. Its objective is to determine whether stabilization training using ultrasonography as a biofeedback tool leads to improved therapeutic outcomes compared with standard physiotherapy. The intervention is intended for patients with chronic lumbosacral spine pain lasting at least three months. Eligibility for participation will be based on clearly defined inclusion criteria. This study will be conducted at REHA MEDICA Rehabilitation and Medical Center in Tarnów, Poland. The investigators plan to enroll approximately 110 patients, with 55 assigned to the control group and 55 to the experimental group.
The therapeutic program in both groups will include manual therapy, selected physical therapy modalities, and therapeutic exercises. Participants will be randomly assigned to either a control group or an experimental group. In the experimental group, biofeedback in the form of ultrasonography will be used during stabilization exercises, whereas in the control group, exercises will be performed without biofeedback.
The following parameters will be analyzed: pain intensity, the degree of disability associated with spinal pain, spinal range of motion, balance parameters assessed using a force platform, level of physical activity, stress severity, and self-reported quality of life.
The following tests and questionnaires will be used in the study:
The force platform will be used to assess balance, including center of pressure (COP) position, COP path length, COP displacement speed, sway range in the sagittal and frontal planes, percentage load on the right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed.
Inclinometer - for measuring the lumbar lordosis angle and the range of motion of the lumbosacral spine.
STarT Back Screening Tool - a questionnaire assessing the risk of developing chronic low back pain.
Oswestry Disability Index (ODI) - an index measuring disability related to lumbosacral spine pain.
McGill Pain Questionnaire - Short Form - evaluating pain quality and intensity. Visual Analog Scale (VAS) - for assessing pain intensity. Physical Activity Questionnaire - assessing the level of physical activity over the past seven days.
Perceived Stress Scale - a subjective measure of stress experienced over the past month.
WHOQOL-BREF - a quality of life questionnaire developed by the World Health Organization (World Health Organization Quality of Life - BREF).
Before entering the program, participants will be examined by a specialist in rehabilitation medicine. Subsequently, the principal investigator (physiotherapist) will conduct a baseline assessment including all analyzed parameters. After completing the qualification process, participants will begin an 8-week physiotherapy program conducted twice weekly. Immediately after completion of the intervention, a post-treatment assessment identical to the baseline evaluation will be performed. A follow-up assessment will then be conducted three months after completion of the therapy.
The study will be conducted under the supervision of qualified medical personnel and in accordance with all applicable safety standards. The results will determine whether the use of ultrasonography-based biofeedback improves clinical and functional outcomes and whether any therapeutic benefits are maintained over time. The findings may contribute to the optimization of rehabilitation programs for patients with chronic lumbosacral spine pain.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed chronic lumbosacral spine pain syndrome (score \>4 on the Keele STarT Back Screening Tool)
- •Lumbosacral pain intensity \>3 on the Visual Analog Scale (VAS) persisting for at least the past 3 months
- •Age between 30 and 65 years
- •No concurrent participation in another rehabilitation program
- •Provision of written informed consent to participate in the study
排除标准
- •Acute phase of lumbosacral spine pain syndrome
- •Presence of neurological symptoms such as paresthesia, dysesthesia, impaired superficial sensation, impaired pain sensation, muscle strength below grade 3 on the Lovett scale in the lower limbs, sphincter dysfunction, or cauda equina syndrome
- •Recent fractures of the spine or pelvis (less than 6 months since injury)
- •Segmental instability confirmed by functional X-ray or magnetic resonance imaging (MRI)
- •Spondylolisthesis greater than Grade I according to the Meyerding classification
- •Coexisting neurological (e.g., Parkinson's disease, neuropathies), autoimmune (e.g., ankylosing spondylitis), orthopedic (lower limb disorders), or oncological diseases
- •Pregnancy
- •Active use of analgesic or anti-inflammatory pharmacotherapy (e.g., steroids, NSAIDs)
- •Concurrent participation in other rehabilitation programs or failure to complete the 8-week therapy program
- •Completion of any structured rehabilitation program within the past 3 months
研究组 & 干预措施
Biofeedback Group
The investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine.
干预措施: Standard Rehabilitation (Other)
Biofeedback Group
The investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine.
干预措施: Biofeedback Ultrasonography (Other)
Control Group
In this group the investigators use standard physiotherapy without ultrasonography as biofeedback.
干预措施: Standard Rehabilitation (Other)
结局指标
主要结局
Balance
时间窗: First examination - before the start of the rehabilitation program
Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed
Balance
时间窗: Second examination - at the end of the eight-week program
Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed
Balance
时间窗: Follow-up assessment at 3 months post-intervention.
Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed
Pain intensity Visual Analog Scale
时间窗: First examination - before the start of the rehabilitation program
The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.
Pain intensity Visual Analog Scale
时间窗: Second examination - at the end of the eight-week program
The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.
Pain intensity Visual Analog Scale
时间窗: Follow-up assessment at 3 months post-intervention.
The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.
Pain Questionnaire
时间窗: First examination - before the start of the rehabilitation program
McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.
Pain Questionnaire
时间窗: Second examination - at the end of the eight-week program
McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.
Pain Questionnaire
时间窗: Follow-up assessment at 3 months post-intervention.
McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.
Disability related to spinal pain
时间窗: First examination - before the start of the rehabilitation program
Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.
Disability related to spinal pain
时间窗: Second examination - at the end of the eight-week program
Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.
Disability related to spinal pain
时间窗: Follow-up assessment at 3 months post-intervention.
Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.
次要结局
- Spinal Range of Motion(First examination - before the start of the rehabilitation program)
- Spinal Range of Motion(Second examination - at the end of the eight-week program)
- Spinal Range of Motion(Follow-up assessment at 3 months post-intervention.)
- Physical activity level(First examination - before the start of the rehabilitation program)
- Physical activity level(Second examination - at the end of the eight-week program)
- Physical activity level(Follow-up assessment at 3 months post-intervention.)
- Stress level(First examination - before the start of the rehabilitation program)
- Stress level(Second examination - at the end of the eight-week program)
- Stress level(Follow-up assessment at 3 months post-intervention.)
- Quality of life questionnaire(First examination - before the start of the rehabilitation program)
- Quality of life questionnaire(Second examination - at the end of the eight-week program)
- Quality of life questionnaire(Follow-up assessment at 3 months post-intervention.)
- Risk of developing chronic low back pain(First examination - before the start of the rehabilitation program)
- Risk of developing chronic low back pain(Second examination - at the end of the eight-week program)
- Risk of developing chronic low back pain(Follow-up assessment at 3 months post-intervention.)
研究者
Krystian Mleczko
Principal Investigator
University of Rzeszow