Low Back Pain, MechanicalNCT04859842
Comparison of Two Electrotherapy Methods on Chronic Low Back Pain
A study testing Pulse Electromagnetic Field and Interferential Current in people with Low Back Pain, Mechanical, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is; to compare the effects of interferential current therapy (IF) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (PEMF) in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Pulse Electromagnetic Field and Interferential Current
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2021to 30 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with nonspecific low back pain
- Symptom onset with more than 3 months
Who cannot join
- History of surgery on low back region
- Structural deformity on the low back region
- Radiculopathy
- Tumor or malignancy
- Any skin condition that prevents usage of electrotherapy
- Having a pace maker or other types of implants on the low back, pelvis and thoracic region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: Comparison of Effectiveness of Pulsed Electromagnetic Field Therapy and Interferential Current on Patients With Chronic Low Back Pain
The purpose of this study is; to compare the effects of interferential current therapy (IF) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (PEMF) in patients with chronic low back pain.
Read the detailed description
The low back is the most common region for musculoskeletal pain. Many factors play a role in the etiology of low back pain. A certain etiological factor or pathophysiological mechanism cannot be found in 85-90% of the patients.
Approximately 80% of those living in industrialized countries experience low back pain in some part of their lives. 10% of low back pain becomes chronic. It is believed that 1% of workforce losses are due to low back pain. This type of pain often occurs when the back muscles, tendons and ligaments are exposed to stress or strain. Mechanical back pains are chronic pain that often affects the lower part of the spine and radiates to the gluteal region. Since daily activities such as leaning, turning, lifting, standing and sitting for a long time increase the pain, the intensity of the pain increases during the day.
Interferential current (IF) therapy is obtained from two medium frequency currents and is applied by delivering a low frequency current (for example 20 to 100 Hz) to the tissue.
Pulsed ElectroMagnetic Field (PEMF) therapy, which is among physical therapy methods, is frequently used in the treatment of knee, hip and spine osteoarthritis symptoms. It is thought that magnetic field therapy improves the oxygen utilization of the cells and the erythrocytes release more oxygen under the influence of the magnetic field, thus having a positive effect on the circulatory system
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Pulse Electromagnetic Field, Interferential Current, Sham
- Keywords
- Rehabilitation, Electric Stimulation Therapy, Quality of Life, Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Electromagnetic FieldOther
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with PEMF in prone position. Each session will be 45 minute long with a 15 minute PEMF therapy and a 30 minute conventional therapy program.
Interferential CurrentOther
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with Interferential current in prone position. Four interferential electrode will be placed on low back region. Each session will be 45 minute long with a 15 minute interferential current and a 30 minute conventional therapy program.
ShamOther
Patients will be treated for two weeks, five days a week, one session a day, and 10 sessions with conventional therapy and sham electrotherapy. Sham application will be performed on prone position with four electrodes and electrodes will stay for 15 minutes on this region.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Electromagnetic Field Group | Active comparator | Pulse Electromagnetic Field Therapy (PEMF) will be applied to patients' low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to PEMF therapy. Receives: Other: Pulse Electromagnetic Field |
| Interferential Current Group | Active comparator | Interferential current will be applied to patients' low back pain region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to Interferential current. Receives: Other: Interferential Current |
| Sham Group | Sham comparator | Sham electrodes will be placed on the low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to sham therapy. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NRS)
It contains 11 digits that should be assigned according to the perceived pain intensity on a numerical scale. The participant chooses the number that best reflects his or her pain. In our study, the patients were informed that the '0' point was not pain at all, and the '10' point expressed unbearable pain.
Measured: two weeks
Secondary outcomes (2)
Roland-Morris Disability Questionnaire
It is a questionnaire developed to evaluate functional disabilities in patients with low back pain. Turkish validity and reliability study was conducted in 2001 (20). In the 24-sentence questionnaire about functional impairments, patients are asked to answer each sentence as yes if it fits their situation, and no if it does not. Yes responses are calculated as "1" and no answers are calculated as "0" points. In this questionnaire with a total score between 0-24, the higher score means more disability.
Measured: two weeks
Euroqol Quality Of Life Scale
EQ-5D is a self-report scale developed by the EuroQoL group, the Western European quality of life research community, and evaluates five dimensions with 1 question each. These five dimensions consist of subtitles of mobility, self-care, usual daily activities, pain / discomfort and anxiety / depression. The answers given to each dimension have 3 options: no problem, some problem and major problem. As a result, 243 possible different health outcomes are defined with the scale. An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate unconsciousness, living dependent on bed, etc. show situations. Also included in the scale is a VAS (EQ-VAS) that includes answers between 0 and 100, ie "0 = the worst health condition imaginable" and "100 = the best health condition imaginable".
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start21 Apr 2021
- Primary completion21 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Three groups with a conventional therapy control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Mustafa Fatih Yaşar, MD, Principal investigator, Bolu Abant Izzet Baylsa UniversityRamazan KURUL, Ph.D, Principal investigator, Bolu Abant Izzet Baylsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859842
- Sponsor's protocol ID
- AIBU-FTR-RK-06
- Status last verified
- Sep 2023
- First submitted
- 22 Apr 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Pulsed Electromagnetic Field Therapy and Interferential Current on Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04859842
- Acronym / sponsor ID
- AIBU-FTR-RK-06
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Rehabilitation, Electric Stimulation Therapy, Quality of Life, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Apr 2021 (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 purpose of this study is; to compare the effects of interferential current therapy (IF) applied in addition to conventional physical therapy on pain, functional status and quality of life compared to pulsed electromagnetic field therapy (PEMF) in patients with chronic low back pain.
Detailed description
The low back is the most common region for musculoskeletal pain. Many factors play a role in the etiology of low back pain. A certain etiological factor or pathophysiological mechanism cannot be found in 85-90% of the patients.
Approximately 80% of those living in industrialized countries experience low back pain in some part of their lives. 10% of low back pain becomes chronic. It is believed that 1% of workforce losses are due to low back pain. This type of pain often occurs when the back muscles, tendons and ligaments are exposed to stress or strain. Mechanical back pains are chronic pain that often affects the lower part of the spine and radiates to the gluteal region. Since daily activities such as leaning, turning, lifting, standing and sitting for a long time increase the pain, the intensity of the pain increases during the day.
Interferential current (IF) therapy is obtained from two medium frequency currents and is applied by delivering a low frequency current (for example 20 to 100 Hz) to the tissue.
Pulsed ElectroMagnetic Field (PEMF) therapy, which is among physical therapy methods, is frequently used in the treatment of knee, hip and spine osteoarthritis symptoms. It is thought that magnetic field therapy improves the oxygen utilization of the cells and the erythrocytes release more oxygen under the influence of the magnetic field, thus having a positive effect on the circulatory system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with a conventional therapy control group.
| Arm | Type | Receives |
|---|---|---|
| Pulse Electromagnetic Field Group | Active comparator | Other: Pulse Electromagnetic FieldPulse Electromagnetic Field Therapy (PEMF) will be applied to patients' low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to PEMF therapy. |
| Interferential Current Group | Active comparator | Other: Interferential CurrentInterferential current will be applied to patients' low back pain region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to Interferential current. |
| Sham Group | Sham comparator | Other: ShamSham electrodes will be placed on the low back region. Also, patients will receive a conventional therapy program consisting of hotpack, ultrasound, and transcutaneous electrical stimulation in addition to sham therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being diagnosed with nonspecific low back pain
- Symptom onset with more than 3 months
Key exclusion criteria (6 listed)
- History of surgery on low back region
- Structural deformity on the low back region
- Radiculopathy
- Tumor or malignancy
- Any skin condition that prevents usage of electrotherapy
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 |
|---|---|---|
| Pulse Electromagnetic FieldPatients will be treated for two weeks, five days a week, one session a day, and 10 sessions with PEMF in prone position. Each session will be 45 minute long with a 15 minute PEMF therapy and a 30 minute conventional therapy program. | Other | Pulse Electromagnetic Field Group |
| Interferential CurrentPatients will be treated for two weeks, five days a week, one session a day, and 10 sessions with Interferential current in prone position. Four interferential electrode will be placed on low back region. Each session will be 45 minute long with a 15 minute interferential current and a 30 minute conventional therapy program. | Other | Interferential Current Group |
| ShamPatients will be treated for two weeks, five days a week, one session a day, and 10 sessions with conventional therapy and sham electrotherapy. Sham application will be performed on prone position with four electrodes and electrodes will stay for 15 minutes on this region. | Other | Sham Group |
Primary outcome
The Numerical Rating Scale (NRS)
Time frame: two weeks
It contains 11 digits that should be assigned according to the perceived pain intensity on a numerical scale. The participant chooses the number that best reflects his or her pain. In our study, the patients were informed that the '0' point was not pain at all, and the '10' point expressed unbearable pain.
2 secondary outcomes
Roland-Morris Disability Questionnaire
Time frame: two weeks
Euroqol Quality Of Life Scale
Time frame: two weeks
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 25 Sep 2023.
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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.
Mustafa Fatih Yaşar, MD principal investigator
Bolu Abant Izzet Baylsa University
Ramazan KURUL, Ph.D principal investigator
Bolu Abant Izzet Baylsa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Electromagnetic Field and Interferential Current in people with Low Back Pain, Mechanical, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 25 Sep 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 Turkey (Türkiye). 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?
The Numerical Rating Scale (NRS) (time frame: two weeks). 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 25 Sep 2023.