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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.
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:
Before and after the session, all the variable measurements will be collected in the same environmental conditions by the same researcher. Basal measurement (before intervention) will be recorded 15 minutes before session for 10 minutes. The second measurement will be taken while the patient recieves the intervention for 20 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham IFC therapy: Control group | Sham Comparator | This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters:
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| IFC therapy: Experimental group | Experimental | This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation: Interferential Current (IFC): Experimental Group | Device | Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
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| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate variability (HRV-a) | 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. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Heart Rate variability (HRV-b) | 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. | Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied. |
| Root-mean-square differences of successive heartbeat intervals (RMSSD-a) | RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Root-mean-square differences of successive heartbeat intervals (RMSSD-b) | RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD. | Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied. |
| Standard Deviation 1 (SD1-a) | SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Standard Deviation 1 (SD1-b) |
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Questionnaire (RMQ-a) | RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability). | Evaluation before intervention (basal): 15 minutes before intervention. |
| Roland Morris Questionnaire (RMQ-b) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manuel Albornoz Cabello | Seville | Spain |
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Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each:
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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.
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| Electrical stimulation: Interferential Current (IFC): Control Group | Device | Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
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SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
| Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied. |
| Standard Deviation 2 (SD2-a) | SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Standard Deviation 2 (SD2-b) | SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it. | Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s. |
| Stress Index (SS-a) | SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Stress Index (SS-b) | SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS. | Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s. |
| Sympathetic / Parasympathetic Ratio (S/PS Ratio-a) | S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio. | Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes. |
| Sympathetic / Parasympathetic Ratio (S/PS Ratio-b) | S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio. | Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s. |
| Numeric Pain Rating Scale (NPRS-a) | 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). | Evaluation before intervention (basal): 15 minutes before intervention. |
| Numeric Pain Rating Scale (NPRS-b) | 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). | Evaluation immediately after treatment session. |
RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability). |
| Evaluation immediately after treatment session. |
| Scale for Personal Psychological Apprehension (SPPA) | SPPA it's a questionnaire made to measure subject's susceptibility to receive electrical stimulation. A scoring of >45 points indicates that subject shouldnt be treated with electrical therapy. | Evaluation before intervention (basal): 15 minutes before intervention. |
| Dosimetry achieved with electrical stimulation | Maximal dosimetry reached during the session will be recorded in mA. | Recorded immediately after treatment session. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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