Chronic Low-back PainNCT05843136
Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.
A study testing physiotherapy treatment in people with Chronic Low-back Pain, run by Universidade Federal do Oeste do Para at 1 site in Brazil.
Trial summary
. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2022to 15 Mar 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both genders
- Aged between 18 and 65 years
- Voluntarily sought the Clinic's physiotherapy service
- Low back pain for more than 12 weeks
- Medical request and diagnosis of low back pain with or without pain radiating to the lower limbs
- Immunization against COVID 19.
- Signature of the free detailed term clarified. (FDTC)
Who cannot join
- Physiotherapy treatment carried out in a period equal to or less than 8 weeks before starting the research
- Reporting any contraindications inherent to the use of electrotherapy
- Participants with fractures or spinal surgery
- Involved in a legal medical dispute
- Diagnosis of fibromyalgia
- Patients with flu-like symptoms during the research period
- Participants who have more than 2 (two) absences will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.
Read the detailed description
Low back pain is characterized by pain and represents a change in health that affects mainly adults, although electrostimulation represents an important tool in the treatment of patients with chronic nonspecific low back pain, the clinical efficacy of the interferential current used in physiotherapy still lacks reinforcement for clinical validation. In this way, the present study evaluated whether the use of interferential current contributes to reducing chronic low back pain and analyzed whether the electrotherapeutic protocol can benefit the physical functionality of patients with chronic low back pain. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. Data analysis was performed using the JAMOVI 2.2.5 software. Our data showed that individuals with interferential current showed significant improvement in pain relief, as well as in the functional pattern of pain improvement. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.
- Conditions
- Chronic Low-back Pain
- Being tested
- physiotherapy treatment
- Keywords
- Interferential Current, Chronic low back pain, Quality of life, Occupational disease, Physical functionality
- Medical subject headings
- Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy treatmentOther
this is an interventional study of the use of 3 physiotherapy treatment techniques in order to evaluate the effectiveness of interferential current in relieving chronic low back pain
| Study group | Role | What they receive |
|---|---|---|
| Intervenction | Experimental | We used the SONOPULSE II device from the manufacturer IBRAMED, the electrodes measuring nine centimeters in length and five centimeters in width, from the manufacturer ARKTUS, of the adhesive plate type.
According to the IBRAMED manual (2011, p. 47), the application is produced by two medium frequency currents through four electrodes, quadripolar method. The current type is tetrapolar interferential and the stimulation mode is automatic vector; the carrier frequency of 4000HZ, AMF modulation frequency of 50HZ, and the sweep frequency of SWEEP will be 20HZ. SWEEP sweep modes with 6 seconds of rise from the modulation frequency to the threshold the sweep frequency upon reaching the threshold immediately decays over the next 6 seconds. The positioning of the four-leaf clover type electrodes and the intensity of the strong current, however comfortable, according to the patient's report. Receives: Other: physiotherapy treatment |
| Control Group 01 | Active comparator | he treatment is based on non-invasive methods, highlighting manual therapy techniques, especially joint manipulation therapy. Manual therapy techniques are adjustments in lumbar rotation. Joint adjustment is a controlled lever-like force with direction, amplitude, and speed that is applied to specific, tissue-adjacent joints. While joint mobilization is manual therapy without the impulse, the joint remains within the physiological range of motion (SILVA et al., 2012). Therefore, a high-velocity, low-amplitude (HVA) manual maneuver was applied. The thrust (impulse) is carried out in the para-physiological environment, between the physiological and anatomical barriers. preload phase before the manipulation, thrust phase where the maneuver is performed with high speed and low amplitude and the resolution phase where the manipulation ends. The maneuver is detailed by the authors Bergmann \& Peterson (2010). Receives: Other: physiotherapy treatment |
| Control Group 02 | Active comparator | The procedure adopted in this group was based on the guidelines and recommendations for non-pharmacological treatment of the Associação Médica Brasileira AMB (RACHED, R.D.V.A. et al, 2013) use of 1 MHZ Ultrasound with a power of 1W/cm2, continuous IBRAMED device for 10 minutes, Wave Diathermy Short for 15 minutes/day, HTM brand, TENS 50 HZ and 50 ms intensity phase according to the patient's threshold, 30 minutes, IBRAMED brand Receives: Other: physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires
Application of Rolland Morris Questionnaires before and after intervention, this questionnaires assesses mild and moderate pain and disability
Measured: 12 months
Isolated comparative evaluation method, before and after, in the three arms, Application of Owestry Questionnaire
Application of Owestry Questionnaire before and after intervention, this questionnaires evaluates more severe disabilities
Measured: 12 months
Isolated comparative evaluation method, before and after, in the three arms, Application analogue visual score for pain
Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 Jan 2022
- Primary completion10 Jan 2023
- Study completion15 Mar 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a randomized clinical trial, was submitted and approved by the Human Ethics Committee (CEP) with opinion 5,175,882, CAEE: 52035721.9.0000.0171. Participants were chosen at random, with single-blind masking, Random Allocation ® software was used to generate random numbers for the intervention and control groups, non-probalistic convenience sample. There were three groups: interventional, control 01 and control 02
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Oeste do Para
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA
- Responsible party
- Principal investigator, LUIZ PAULO SOBRAL PEREIRA, Universidade Federal do Oeste do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843136
- Sponsor's protocol ID
- CAEE: 52035721.9.0000.0171
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT05843136
- Acronym / sponsor ID
- CAEE: 52035721.9.0000.0171
- Conditions
- Chronic Low-back Pain
- Keywords
- Interferential Current, Chronic low back pain, Quality of life, Occupational disease, Physical functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal do Oeste do ParaUniversity, hospital or other
- Collaborators
- Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 6 May 2023 (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.
. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.
Detailed description
Low back pain is characterized by pain and represents a change in health that affects mainly adults, although electrostimulation represents an important tool in the treatment of patients with chronic nonspecific low back pain, the clinical efficacy of the interferential current used in physiotherapy still lacks reinforcement for clinical validation. In this way, the present study evaluated whether the use of interferential current contributes to reducing chronic low back pain and analyzed whether the electrotherapeutic protocol can benefit the physical functionality of patients with chronic low back pain. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. Data analysis was performed using the JAMOVI 2.2.5 software. Our data showed that individuals with interferential current showed significant improvement in pain relief, as well as in the functional pattern of pain improvement. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The research is a randomized clinical trial, was submitted and approved by the Human Ethics Committee (CEP) with opinion 5,175,882, CAEE: 52035721.9.0000.0171. Participants were chosen at random, with single-blind masking, Random Allocation ® software was used to generate random numbers for the intervention and control groups, non-probalistic convenience sample. There were three groups: interventional, control 01 and control 02
| Arm | Type | Receives |
|---|---|---|
| Intervenction | Experimental | Other: physiotherapy treatmentWe used the SONOPULSE II device from the manufacturer IBRAMED, the electrodes measuring nine centimeters in length and five centimeters in width, from the manufacturer ARKTUS, of the adhesive plate type. According to the IBRAMED manual (2011, p. 47), the application is produced by two medium frequency currents through four electrodes, quadripolar method. The current type is tetrapolar interferential and the stimulation mode is automatic vector; the carrier frequency of 4000HZ, AMF modulation frequency of 50HZ, and the sweep frequency of SWEEP will be 20HZ. SWEEP sweep modes with 6 seconds of rise from the modulation frequency to the threshold the sweep frequency upon reaching the threshold immediately decays over the next 6 seconds. The positioning of the four-leaf clover type electrodes and the intensity of the strong current, however comfortable, according to the patient's report. |
| Control Group 01 | Active comparator | Other: physiotherapy treatmenthe treatment is based on non-invasive methods, highlighting manual therapy techniques, especially joint manipulation therapy. Manual therapy techniques are adjustments in lumbar rotation. Joint adjustment is a controlled lever-like force with direction, amplitude, and speed that is applied to specific, tissue-adjacent joints. While joint mobilization is manual therapy without the impulse, the joint remains within the physiological range of motion (SILVA et al., 2012). Therefore, a high-velocity, low-amplitude (HVA) manual maneuver was applied. The thrust (impulse) is carried out in the para-physiological environment, between the physiological and anatomical barriers. preload phase before the manipulation, thrust phase where the maneuver is performed with high speed and low amplitude and the resolution phase where the manipulation ends. The maneuver is detailed by the authors Bergmann \& Peterson (2010). |
| Control Group 02 | Active comparator | Other: physiotherapy treatmentThe procedure adopted in this group was based on the guidelines and recommendations for non-pharmacological treatment of the Associação Médica Brasileira AMB (RACHED, R.D.V.A. et al, 2013) use of 1 MHZ Ultrasound with a power of 1W/cm2, continuous IBRAMED device for 10 minutes, Wave Diathermy Short for 15 minutes/day, HTM brand, TENS 50 HZ and 50 ms intensity phase according to the patient's threshold, 30 minutes, IBRAMED brand |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals of both genders
- Aged between 18 and 65 years
- Voluntarily sought the Clinic's physiotherapy service
- Low back pain for more than 12 weeks
- Medical request and diagnosis of low back pain with or without pain radiating to the lower limbs
Key exclusion criteria (7 listed)
- Physiotherapy treatment carried out in a period equal to or less than 8 weeks before starting the research
- Reporting any contraindications inherent to the use of electrotherapy
- Participants with fractures or spinal surgery
- Involved in a legal medical dispute
- Diagnosis of fibromyalgia
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 |
|---|---|---|
| physiotherapy treatmentthis is an interventional study of the use of 3 physiotherapy treatment techniques in order to evaluate the effectiveness of interferential current in relieving chronic low back pain | Other | Control Group 01, Control Group 02, Intervenction |
Primary outcome
Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires
Time frame: 12 months
Application of Rolland Morris Questionnaires before and after intervention, this questionnaires assesses mild and moderate pain and disability
Isolated comparative evaluation method, before and after, in the three arms, Application of Owestry Questionnaire
Time frame: 12 months
Application of Owestry Questionnaire before and after intervention, this questionnaires evaluates more severe disabilities
Isolated comparative evaluation method, before and after, in the three arms, Application analogue visual score for pain
Time frame: 12 months
Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference
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 6 May 2023.
- Individual participant dataSharing planned: No
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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 physiotherapy treatment in people with Chronic Low-back Pain, run by Universidade Federal do Oeste do Para at 1 site in Brazil.
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 7 inclusion and 7 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 6 May 2023. 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 Brazil. 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. 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?
Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires (time frame: 12 months). The study lists 3 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 6 May 2023.