Mechanical Low Back PainNCT06133855
Impact of Electromagnetic Field Therapy on Pain and Function in Patients With Mechanical Back Pain
A study testing Pulsed electromagnetic field and traditional physical therapy program in people with Mechanical Low Back Pain, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study aims to investigate the impact of electromagnetic field therapy on pain severity and functional disability in mechanical back pain patients suffering from myofascial trigger points. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Pulsed electromagnetic field and traditional physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2023to 29 Feb 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients age from 20 to 40 years for both genders.
- Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
- Patients suffering from active MTrPS in lower back muscles.
- The study patients must be willing to participate in the study.
Who cannot join
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
- Psychiatric/mental deficit.
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
- Vertebral compression fracture
- Pregnancy and lactation.
- Existing lower limb symptoms.
- Cardiopulmonary disorders with reduced activity tolerance. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Electromagnetic Field Therapy on Pain Severity and Functional Disability in Patients With Mechanical Back Pain: a Randomized Controlled Trial
This study aims to investigate the impact of electromagnetic field therapy on pain severity and functional disability in mechanical back pain patients suffering from myofascial trigger points.
Read the detailed description
Lower back pain, or LBP, is a major global health issue that affects functioning, social participation, and personal financial prosperity on a variety of biophysical, psychological, and social levels. In today's industrial society, it impacts roughly 50-80% of people who are of working age. Mechanical back pain patients suffer from myofascial trigger points (MTrPs), which are classified as either active or latent. Activated MTrPs cause either sudden onset of pain or in response to movement, stretching, or compression. Latent MTrPs are typically symptom-free, but when squeezed, they can re-create pain or irritation. Muscle weakness and limited ROM are other common signs of mechanical back pain, along with local as well as referred pain that affect patients functional activities.
Recently, there has been a focus on non-pharmacotherapy for low back pain. One of them is electromagnetic field therapy (PEMF) which uses electromagnetic field pulses to stimulate tissue healing without causing heat damage to the tissue. The FDA has given electromagnetic field therapy devices approval for treating post-operative pain, swelling, and osteoarthritis. Furthermore, PEMF devices are frequently used to treat bone fractures, inflammation, arthritis, pain, swelling, and chronic wounds.
Thus, the purpose of this study is to ascertain how electromagnetic field therapy affects the degree of pain and functional impairment in mechanical back pain patients suffering from myofascial trigger points.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Pulsed electromagnetic field, traditional physical therapy program
- Keywords
- Electromagnetic Field, Mechanical back pain, Myofascial trigger point, Pain severity
- 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.
Pulsed electromagnetic fieldRadiation
The experimental group will be treated with an ASA magnetic field device (Automatic PMT Quattro Pro) at a frequency of 50 Hz in addition to the traditional physical therapy program. Each session will consist of 20 minutes of the patient lying prone and exposed to low-intensity 20-gauss PEMF.
traditional physical therapy programOther
A traditional physical therapy program will include
Infrared radiation for 20 minutes per session for 3 sessions per week for 4 weeks
Ultrasonic: 1 MHz; continuous mode of application: 1.5 w/cm2 for 5 minutes; 3 sessions per week for 4 weeks.
stretching exercises for the hamstring, calf muscles, and back muscles. 3 sessions per week for 4 weeks
Strengthening exercises for back and abdominal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field | Experimental | the patients will receive pulsed electromagnetic field plus traditional physical therapy program three times a week for four weeks Receives: Radiation: Pulsed electromagnetic field; Other: traditional physical therapy program |
| traditional physical therapy program | Active comparator | the patients will receive traditional physical therapy program three times a week for four week Receives: Other: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel.
Measured: up to four weeks
Secondary outcomes (3)
functional disability
Arabic version of Oswestry Disability Index will be used for assessment of functional disability
Measured: up to four weeks
lumbar flexion and extension assessment
modified-modified Schober test will be used to assess lumbar flexion and extension
Measured: up to four weeks
lumbar lateral flexion assessment
tape measurement will be used to assess lumbar lateral flexion
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- pulsed electromagnetic fields therapy and traditional physical therapy program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
- Investigators
- Ghada MR Koura, Ass. prof, Study director, King Khalid University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133855
- Sponsor's protocol ID
- HAPO-06-B-001; ECM#2023-2104
- Status last verified
- Mar 2024
- First submitted
- 10 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Electromagnetic Field Therapy on Pain Severity and Functional Disability in Patients With Mechanical Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06133855
- Acronym / sponsor ID
- HAPO-06-B-001; ECM#2023-2104
- Conditions
- Mechanical Low Back Pain
- Keywords
- Electromagnetic Field, Mechanical back pain, Myofascial trigger point, Pain severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- King Khalid University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Nov 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.
This study aims to investigate the impact of electromagnetic field therapy on pain severity and functional disability in mechanical back pain patients suffering from myofascial trigger points.
Detailed description
Lower back pain, or LBP, is a major global health issue that affects functioning, social participation, and personal financial prosperity on a variety of biophysical, psychological, and social levels. In today's industrial society, it impacts roughly 50-80% of people who are of working age. Mechanical back pain patients suffer from myofascial trigger points (MTrPs), which are classified as either active or latent. Activated MTrPs cause either sudden onset of pain or in response to movement, stretching, or compression. Latent MTrPs are typically symptom-free, but when squeezed, they can re-create pain or irritation. Muscle weakness and limited ROM are other common signs of mechanical back pain, along with local as well as referred pain that affect patients functional activities.
Recently, there has been a focus on non-pharmacotherapy for low back pain. One of them is electromagnetic field therapy (PEMF) which uses electromagnetic field pulses to stimulate tissue healing without causing heat damage to the tissue. The FDA has given electromagnetic field therapy devices approval for treating post-operative pain, swelling, and osteoarthritis. Furthermore, PEMF devices are frequently used to treat bone fractures, inflammation, arthritis, pain, swelling, and chronic wounds.
Thus, the purpose of this study is to ascertain how electromagnetic field therapy affects the degree of pain and functional impairment in mechanical back pain patients suffering from myofascial trigger points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pulsed electromagnetic fields therapy and traditional physical therapy program
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field | Experimental | Radiation: Pulsed electromagnetic field, Other: traditional physical therapy programthe patients will receive pulsed electromagnetic field plus traditional physical therapy program three times a week for four weeks |
| traditional physical therapy program | Active comparator | Other: traditional physical therapy programthe patients will receive traditional physical therapy program three times a week for four week |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patients age from 20 to 40 years for both genders.
- Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
- Patients suffering from active MTrPS in lower back muscles.
- The study patients must be willing to participate in the study.
Key exclusion criteria (7 listed)
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
- Psychiatric/mental deficit.
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
- Vertebral compression fracture
- Pregnancy and lactation.
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 |
|---|---|---|
| Pulsed electromagnetic fieldThe experimental group will be treated with an ASA magnetic field device (Automatic PMT Quattro Pro) at a frequency of 50 Hz in addition to the traditional physical therapy program. Each session will consist of 20 minutes of the patient lying prone and exposed to low-intensity 20-gauss PEMF. | Radiation | Pulsed electromagnetic field |
| traditional physical therapy programA traditional physical therapy program will include Infrared radiation for 20 minutes per session for 3 sessions per week for 4 weeks Ultrasonic: 1 MHz; continuous mode of application: 1.5 w/cm2 for 5 minutes; 3 sessions per week for 4 weeks. stretching exercises for the hamstring, calf muscles, and back muscles. 3 sessions per week for 4 weeks Strengthening exercises for back and abdominal muscles. | Other | Pulsed electromagnetic field, traditional physical therapy program |
Primary outcome
pain intensity
Time frame: up to four weeks
A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel.
3 secondary outcomes
functional disability
Time frame: up to four weeks
lumbar flexion and extension assessment
Time frame: up to four weeks
lumbar lateral flexion assessment
Time frame: up to four 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 5 Mar 2024.
Related trials for Mechanical Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
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Fusion or Not - a Study on Low Back Pain
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Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
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Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
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.
Ghada MR Koura, Ass. prof study director
King Khalid University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field and traditional physical therapy program in people with Mechanical Low Back Pain, run by Cairo University at 1 site in Saudi Arabia.
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 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 5 Mar 2024. 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 Saudi Arabia. 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?
pain intensity (time frame: up to four 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 5 Mar 2024.