Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Heart Rate variability (HRV-b)
研究概览
简要总结
The aim of this study it's to analyze the relationship between autonomic nervous system balance (ANSb) and chronic pain conditions, especially in this case, non-especific chronic low back pain (CLBP).
Most of physiotherapy approaches focus only in biomechanical aspects, leaving aside what kind of factors could perpetuate CLBP. Since 1985, ANSb was studied due to its potential contribution to chronic pain.
Electrical stimulation, through interferential currents (IFC), it's a safe and well-known therapy used in CLBP with good outcomes regarding pain relief.
The main objective of this study it's to quantify the association between CLBP and ANSb alterations. In second place, the research team aims to record the influence of IFC over pain and ANSb in those subjects.
详细描述
In the first place, a meeting will be organized with the patients to resolve any doubt about the study and its process. The investigators will make sure every instruction is understandable, giving enough time to read and ask pertinent questions.
Secondly, patients will be provided of an informed consent specific for the present study, according to the legal forms. Participants must agree with all the information and sign the document.
At this point, patients will be interviewed individually by a researcher to collect all the data regarding to the Clinical History in Physiotherapy.
In the next step, patients will be randomized into two different groups by choosing one opaque envelope, containing a number for the allocation. A researcher will make the final allocation depending on the number. Patients were unaware of the group allocation for masking.
This study has to possible groups with a common indication for both:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Randomization process will be masked by opaques envelopes with numbers. Participants choose one random envelope, unaware the number and group relation. Later, a researcher will associate participants, groups and numbers.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with cronic low back pain with at least 3 months of evolution.
- •Subjects with a minimal pain of 3/10 according to NPRS
- •Subjects with informed consent read and signed.
- •Subjects not undergoing any other physical therapy intervention.
排除标准
- •Any uncontrolled neurological or cardiac disorder.
- •Personal Psychological Apprehension Scale (PPAS) score higher than 37.
- •Contraindication for electrical stimulation.
- •Any regular use of medications known to affect the function of the autonomic nervous system (ANS) or pain perception, including antidepressant, benzodiazepines, anti-inflammatory drugs and beta-blockers, 2 weeks before participating in this study.
- •Ineligibility to participate determined by the researches.
- •Neurological, musculoskeletal or sensory affectations.
- •Evidence of infectious process, fever or hypotension.
- •Metallic implants in low back area or treated area
- •No surgical interventions in low back area
- •Not being under pharmacological treatment with influence in Autonomic Nervous System like antidepressants.
研究组 & 干预措施
Sham IFC therapy: Control group
This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).
IFC parameters:
- Carrier frequency of 4000 Hz
- Amplitude modulated frequency of 65 Hz (AMF)
- Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
- NO intensity (0 mA)
- Session duration: 25 minutes
干预措施: Electrical stimulation: Interferential Current (IFC): Control Group (Device)
IFC therapy: Experimental group
This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).
IFC parameters:
- Carrier frequency of 4000 Hz
- Amplitude modulated frequency of 65 Hz (AMF)
- Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
- Intensity will depend on subjet's tolerance but without generating visible muscle twitches.
- Session duration: 25 minutes
干预措施: Electrical stimulation: Interferential Current (IFC): Experimental Group (Device)
结局指标
主要结局
Heart Rate variability (HRV-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Root-mean-square differences of successive heartbeat intervals (RMSSD-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Root-mean-square differences of successive heartbeat intervals (RMSSD-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
Standard Deviation 1 (SD1-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Heart Rate variability (HRV-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
Standard Deviation 1 (SD1-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Standard Deviation 2 (SD2-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Standard Deviation 2 (SD2-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Stress Index (SS-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Stress Index (SS-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
Numeric Pain Rating Scale (NPRS-a)
时间窗: Evaluation before intervention (basal): 15 minutes before intervention.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Numeric Pain Rating Scale (NPRS-b)
时间窗: Evaluation immediately after treatment session.
NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
时间窗: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
次要结局
- Dosimetry achieved with electrical stimulation(Recorded immediately after treatment session.)
- Roland Morris Questionnaire (RMQ-a)(Evaluation before intervention (basal): 15 minutes before intervention.)
- Roland Morris Questionnaire (RMQ-b)(Evaluation immediately after treatment session.)
- Scale for Personal Psychological Apprehension (SPPA)(Evaluation before intervention (basal): 15 minutes before intervention.)
研究者
Dr. Manuel Albornoz Cabello
Doctor in Physiotherapy (PhD)
University of Seville