Chronic Low-back PainNCT04483128
Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
A study testing Electrical stimulation: Interferential Current (IFC): Experimental Group in people with Chronic Low-back Pain and Chronic Pain, run by University of Seville at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Chronic Low-back Pain, Chronic Pain, Autonomic Imbalance
- What is being tested?
- Electrical stimulation: Interferential Current (IFC): Experimental Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any uncontrolled neurological or cardiac disorder.
- Personal Psychological Apprehension Scale (PPAS) score higher than 37.5.
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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:
- Experimental group: Patients allocated in this group will receive one single session of interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern (quadripolar technique). Intensity was adjusted according to patient's tolerance without visible muscle twitches. The session will last 25 min.
- Control group: This group will receive the same intervention than experimental one but with no intensity, for 25 minutes. Patients will keep his general practitioner's indications about pharmacology.
- Common indication: Both groups will get instructions to perform a set of home-based exercises for core strengthening after variable collecting.
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.
- Conditions
- Chronic Low-back Pain, Chronic Pain, Autonomic Imbalance
- Being tested
- Electrical stimulation: Interferential Current (IFC): Experimental Group, Electrical stimulation: Interferential Current (IFC): Control Group
- Keywords
- electrical stimulation, interferential current, autonomic balance, chronic low back pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation: Interferential Current (IFC): Experimental GroupDevice
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. 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 generate visible muscle twitches.
- Session duration: 25 minutes
Electrical stimulation: Interferential Current (IFC): Control GroupDevice
Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. 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
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. Carrier frequency of 4000 Hz
2. Amplitude modulated frequency of 65 Hz (AMF)
3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
4. NO intensity (0 mA)
5. Session duration: 25 minutes Receives: Device: Electrical stimulation: Interferential Current (IFC): Control Group |
| 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:
1. Carrier frequency of 4000 Hz
2. Amplitude modulated frequency of 65 Hz (AMF)
3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
4. Intensity will depend on subjet's tolerance but without generating visible muscle twitches.
5. Session duration: 25 minutes Receives: Device: Electrical stimulation: Interferential Current (IFC): Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
Standard Deviation 1 (SD1-b)
SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Evaluation immediately after treatment session.
Secondary outcomes (4)
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).
Measured: Evaluation before intervention (basal): 15 minutes before intervention.
Roland Morris Questionnaire (RMQ-b)
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).
Measured: 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.
Measured: Evaluation before intervention (basal): 15 minutes before intervention.
Dosimetry achieved with electrical stimulation
Maximal dosimetry reached during the session will be recorded in mA.
Measured: Recorded immediately after treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each: * Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection. * Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Manuel Albornoz Cabello, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483128
- Sponsor's protocol ID
- CIFSNA2020
- Status last verified
- Jun 2021
- First submitted
- 14 Jul 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.
- ClinicalTrials.gov ID
- NCT04483128
- Acronym / sponsor ID
- CIFSNA2020
- Conditions
- Chronic Low-back Pain, Chronic Pain, Autonomic Imbalance
- Keywords
- electrical stimulation, interferential current, autonomic balance, chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Experimental group: Patients allocated in this group will receive one single session of interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern (quadripolar technique). Intensity was adjusted according to patient's tolerance without visible muscle twitches. The session will last 25 min.
- Control group: This group will receive the same intervention than experimental one but with no intensity, for 25 minutes. Patients will keep his general practitioner's indications about pharmacology.
- Common indication: Both groups will get instructions to perform a set of home-based exercises for core strengthening after variable collecting.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each: * Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection. * Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology.
| Arm | Type | Receives |
|---|---|---|
| Sham IFC therapy: Control group | Sham comparator | Device: Electrical stimulation: Interferential Current (IFC): Control GroupThis group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: 1. Carrier frequency of 4000 Hz 2. Amplitude modulated frequency of 65 Hz (AMF) 3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. 4. NO intensity (0 mA) 5. Session duration: 25 minutes |
| IFC therapy: Experimental group | Experimental | Device: Electrical stimulation: Interferential Current (IFC): Experimental GroupThis group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC). IFC parameters: 1. Carrier frequency of 4000 Hz 2. Amplitude modulated frequency of 65 Hz (AMF) 3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. 4. Intensity will depend on subjet's tolerance but without generating visible muscle twitches. 5. Session duration: 25 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Any uncontrolled neurological or cardiac disorder.
- Personal Psychological Apprehension Scale (PPAS) score higher than 37.5.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation: Interferential Current (IFC): Experimental GroupApplication of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters: 1. Carrier frequency of 4000 Hz 2. Amplitude modulated frequency of 65 Hz (AMF) 3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. 4. Intensity will depend on subjet's tolerance but without generate visible muscle twitches. 5. Session duration: 25 minutes | Device | IFC therapy: Experimental group |
| Electrical stimulation: Interferential Current (IFC): Control GroupApplication of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters: 1. Carrier frequency of 4000 Hz 2. Amplitude modulated frequency of 65 Hz (AMF) 3. Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique. 4. NO intensity (0 mA) 5. Session duration: 25 minutes | Device | Sham IFC therapy: Control group |
Primary outcome
Heart Rate variability (HRV-a)
Time frame: 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.
Heart Rate variability (HRV-b)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Standard Deviation 1 (SD1-b)
Time frame: 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-a)
Time frame: 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.
Standard Deviation 2 (SD2-b)
Time frame: 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.
Stress Index (SS-a)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
Time frame: 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.
Numeric Pain Rating Scale (NPRS-a)
Time frame: 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)
Time frame: 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).
4 secondary outcomes
Roland Morris Questionnaire (RMQ-a)
Time frame: Evaluation before intervention (basal): 15 minutes before intervention.
Roland Morris Questionnaire (RMQ-b)
Time frame: Evaluation immediately after treatment session.
Scale for Personal Psychological Apprehension (SPPA)
Time frame: Evaluation before intervention (basal): 15 minutes before intervention.
Dosimetry achieved with electrical stimulation
Time frame: Recorded immediately after treatment session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation: Interferential Current (IFC): Experimental Group in people with Chronic Low-back Pain and Chronic Pain, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate variability (HRV-a) (time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.