Low Back PainNCT05202691
Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
A study testing Group 1 (Physical Therapy+Magnetic Field Therapy) and Group 2 (Physical Therapy) in people with Low Back Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Group 1 (Physical Therapy+Magnetic Field Therapy) and Group 2 (Physical Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2022to 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
- The inclusion criteria were individuals aged between 18 and 65 years with a diagnosis of non-specific low back pain, with or without lower limb irradiation, lasting at least 6 weeks.
Who cannot join
- Pregnancy, spinal tumor or infection, diabetes, spinal fracture or previous spine surgery.
- Patients with a history of rehabilitation treatment for back pain within the preceding month
- Unstable medical disorder not controlled by standard treatment and those with a cardiac pacemaker or using any other electrical devices or prosthesis.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complutense University of Madrid
Madrid
Isidro Fernández-López, Dr., +34625598970, isidrofelo@gmail.com
Isidro Fernández-López, Dr.
About this study
A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. The interventions are conducted in 3 sessions provided during 3 weeks.The lumbar pain and disability are assessed before and after the intervention, and lumbar flexion and extension pain are assessed before and after each session in all the participants.
Read the detailed description
This study is a randomized controlled trial evaluating clinical effects of a protocol of Physical Therapy Treatment (PTT), via manual therapy and active mobilization, adding or not a magnetic field therapy in people with non-specific low back pain lasting at least 6 weeks. Participants were randomized to receive either a PTT protocol including a magnetic stimulation treatment or the same PTT protocol with a sham magnetic intervention. The interventions are conducted in 3 sessions provided during 3 weeks.
Intervention:
A description of the 2 groups of treatment:
- - Experimental group 1: a protocol of physical therapy treatment including:
- Manual therapy techniques for inhibition of piriformis, quadratus lumbar, and paravertebral muscles in prone position and bilaterally.
- 2 functional techniques applied to the sacrum in prone position.
- A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
- Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
- Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
- Active gluteus maximus contraction in supine position bilaterally. To this protocol, a 15 minutes of magnetic field therapy treatment applied to the lumbosacral region in prone position is added.
- - Experimental group 2: the same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected device during 15 minutes.
- Conditions
- Low Back Pain
- Being tested
- Group 1 (Physical Therapy+Magnetic Field Therapy), Group 2 (Physical Therapy)
- Keywords
- low back pain, physical therapy, rehabilitation, magnetic field therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (Physical Therapy+Magnetic Field Therapy)Other
Also called physical therapy and magnetic field therapy for low back pain
A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain) adding a Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany)
Group 2 (Physical Therapy)Other
Also called physical therapy for low back pain
A Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Physical Therapy+Magnetic Field Therapy) | Experimental | Physical Therapy Protocol plus Magnetic Field Therapy
A protocol of physical therapy treatment including:
* Manual therapy techniques for inhibition of piriformis, quadratus lumbaris, and paravertebral muscles in prone position and bilaterally.
* 2 functional techniques applied to the sacrum in prone position.
* A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
* Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
* Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
* Active gluteus maximus contraction in supine position bilaterally.
To this protocol, a 15 minutes of Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) applied to the lumbosacral region in prone position is added. Receives: Other: Group 1 (Physical Therapy+Magnetic Field Therapy) |
| Group 2 (Physical Therapy) | Active comparator | Physical Therapy Protocol alone:
The same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) during 15 minutes. Receives: Other: Group 2 (Physical Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar pain change with the Pain Detect Questionnaire
lumbar pain at this moment and in the last 4 weeks evaluated with the Pain Detect Questionnaire. The Questionnaire has a maximum score of 35 and a minimum score of 0. Lower scores mean a better outcome.
Measured: Change from Baseline Lumbar pain at 4 weeks.
Disability Questionnaire 1 change
Disability Questionnaire assessed with the Roland-Morris Questionnaire. The Questionnaire has a maximum score of 24 and a minimum score of 0. Lower scores mean a better outcome.
Measured: Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire 2 change
Disability Questionnaire 2 assessed with the Oswestry Disability Index. The Oswestry Disability Index is scored from 0 (absence of disability) to 100 (maximum disability). This questionnaire has 10 multiple-choice questions, each of which may be scored between 0 (no disability) and 5 (maximum disability). Lower scores mean a better outcome.
Measured: Change from Baseline degree of diability at 4 weeks.
Secondary outcomes (3)
Lumbar flexion Numerical Rating Scale
Lumbar flexion evaluated with a Numerical Rating Scale. The minimum value is 0 and the maximum value is 10. Lower scores mean a better outcome.
Measured: 4 weeks (immediately before and after each of the sessions)
Lumbar extension Numerical Rating Scale
Lumbar extension evaluated with a Numerical Rating Scale. The minimum value is 0 and the maximum value is 10. Lower scores mean a better outcome.
Measured: 4 weeks (immediately before and after each of the sessions)
Finger to Floor test
Lumbar mobility evaluated with the finger-to-floor test, assessed before and after each session in all the participants. The minimum value is 0 centimeters and the maximum value depending the flexibility os each participant and the distance, in centimeters between fingers anthe floor. Lower distance in centimeters means a better outcome.
Measured: 4 weeks (immediately before and after each of the sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- This study is a randomized controlled trial evaluating clinical effects in people with low back pain who are divided into 2 groups of treatment, where the interventions are conducted in 3 sessions provided during 3 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isidro Fernández-López, Dr., Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202691
- Sponsor's protocol ID
- ComplutenseHolystic
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.
PubMed 17454079Daish C, Blanchard R, Fox K, Pivonka P, Pirogova E. The Application of Pulsed Electromagnetic Fields (PEMFs) for Bone Fracture Repair: Past and Perspective Findings. Ann Biomed Eng. 2018 Apr;46(4):525-542. doi: 10.1007/s10439-018-1982-1. Epub 2018 Jan 22.
PubMed 29356996Hu H, Yang W, Zeng Q, Chen W, Zhu Y, Liu W, Wang S, Wang B, Shao Z, Zhang Y. Promising application of Pulsed Electromagnetic Fields (PEMFs) in musculoskeletal disorders. Biomed Pharmacother. 2020 Nov;131:110767. doi: 10.1016/j.biopha.2020.110767. Epub 2020 Sep 23.
PubMed 33152929
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
- ClinicalTrials.gov ID
- NCT05202691
- Acronym / sponsor ID
- ComplutenseHolystic
- Conditions
- Low Back Pain
- Keywords
- low back pain, physical therapy, rehabilitation, magnetic field therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Jan 2022 (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.
A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. The interventions are conducted in 3 sessions provided during 3 weeks.The lumbar pain and disability are assessed before and after the intervention, and lumbar flexion and extension pain are assessed before and after each session in all the participants.
Detailed description
This study is a randomized controlled trial evaluating clinical effects of a protocol of Physical Therapy Treatment (PTT), via manual therapy and active mobilization, adding or not a magnetic field therapy in people with non-specific low back pain lasting at least 6 weeks. Participants were randomized to receive either a PTT protocol including a magnetic stimulation treatment or the same PTT protocol with a sham magnetic intervention. The interventions are conducted in 3 sessions provided during 3 weeks.
Intervention:
A description of the 2 groups of treatment:
- - Experimental group 1: a protocol of physical therapy treatment including:
- Manual therapy techniques for inhibition of piriformis, quadratus lumbar, and paravertebral muscles in prone position and bilaterally.
- 2 functional techniques applied to the sacrum in prone position.
- A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
- Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
- Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
- Active gluteus maximus contraction in supine position bilaterally. To this protocol, a 15 minutes of magnetic field therapy treatment applied to the lumbosacral region in prone position is added.
- - Experimental group 2: the same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected device during 15 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial evaluating clinical effects in people with low back pain who are divided into 2 groups of treatment, where the interventions are conducted in 3 sessions provided during 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Physical Therapy+Magnetic Field Therapy) | Experimental | Other: Group 1 (Physical Therapy+Magnetic Field Therapy)Physical Therapy Protocol plus Magnetic Field Therapy A protocol of physical therapy treatment including: * Manual therapy techniques for inhibition of piriformis, quadratus lumbaris, and paravertebral muscles in prone position and bilaterally. * 2 functional techniques applied to the sacrum in prone position. * A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally. * Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally. * Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally. * Active gluteus maximus contraction in supine position bilaterally. To this protocol, a 15 minutes of Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) applied to the lumbosacral region in prone position is added. |
| Group 2 (Physical Therapy) | Active comparator | Other: Group 2 (Physical Therapy)Physical Therapy Protocol alone: The same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) during 15 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were individuals aged between 18 and 65 years with a diagnosis of non-specific low back pain, with or without lower limb irradiation, lasting at least 6 weeks.
Key exclusion criteria (3 listed)
- Pregnancy, spinal tumor or infection, diabetes, spinal fracture or previous spine surgery.
- Patients with a history of rehabilitation treatment for back pain within the preceding month
- Unstable medical disorder not controlled by standard treatment and those with a cardiac pacemaker or using any other electrical devices or prosthesis.
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 |
|---|---|---|
| Group 1 (Physical Therapy+Magnetic Field Therapy)Also: physical therapy and magnetic field therapy for low back painA Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain) adding a Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) | Other | Group 1 (Physical Therapy+Magnetic Field Therapy) |
| Group 2 (Physical Therapy)Also: physical therapy for low back painA Physical Therapy Protocol (including manual therapy, stretching and exercise for low back pain) | Other | Group 2 (Physical Therapy) |
Primary outcome
Lumbar pain change with the Pain Detect Questionnaire
Time frame: Change from Baseline Lumbar pain at 4 weeks.
lumbar pain at this moment and in the last 4 weeks evaluated with the Pain Detect Questionnaire. The Questionnaire has a maximum score of 35 and a minimum score of 0. Lower scores mean a better outcome.
Disability Questionnaire 1 change
Time frame: Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire assessed with the Roland-Morris Questionnaire. The Questionnaire has a maximum score of 24 and a minimum score of 0. Lower scores mean a better outcome.
Disability Questionnaire 2 change
Time frame: Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire 2 assessed with the Oswestry Disability Index. The Oswestry Disability Index is scored from 0 (absence of disability) to 100 (maximum disability). This questionnaire has 10 multiple-choice questions, each of which may be scored between 0 (no disability) and 5 (maximum disability). Lower scores mean a better outcome.
3 secondary outcomes
Lumbar flexion Numerical Rating Scale
Time frame: 4 weeks (immediately before and after each of the sessions)
Lumbar extension Numerical Rating Scale
Time frame: 4 weeks (immediately before and after each of the sessions)
Finger to Floor test
Time frame: 4 weeks (immediately before and after each of the sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 17454079Markov MS. Magnetic field therapy: a review. Electromagn Biol Med. 2007;26(1):1-23. doi: 10.1080/15368370600925342.
- Background: PubMed 29356996Daish C, Blanchard R, Fox K, Pivonka P, Pirogova E. The Application of Pulsed Electromagnetic Fields (PEMFs) for Bone Fracture Repair: Past and Perspective Findings. Ann Biomed Eng. 2018 Apr;46(4):525-542. doi: 10.1007/s10439-018-1982-1. Epub 2018 Jan 22.
- Background: PubMed 33152929Hu H, Yang W, Zeng Q, Chen W, Zhu Y, Liu W, Wang S, Wang B, Shao Z, Zhang Y. Promising application of Pulsed Electromagnetic Fields (PEMFs) in musculoskeletal disorders. Biomed Pharmacother. 2020 Nov;131:110767. doi: 10.1016/j.biopha.2020.110767. Epub 2020 Sep 23.
- 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.
Isidro Fernández-López, Dr. principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (Physical Therapy+Magnetic Field Therapy) and Group 2 (Physical Therapy) in people with Low Back Pain, run by Universidad Complutense de Madrid 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isidro Fernández-López, Dr. (+34625598970, isidrofelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar pain change with the Pain Detect Questionnaire (time frame: Change from Baseline Lumbar pain at 4 weeks.). 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?
On the ClinicalTrials.gov record for NCT05202691, which also lists 3 linked publications.
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 21 Jan 2022.