Lower Back PainNCT04347265
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain
A study testing NMP in people with Lower Back Pain, run by University of Seville at 1 site in Spain.
Trial summary
In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- NMP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2020to 1 Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Lower Back Pain
- Having no other therapy
Who cannot join
- Other pathology (discal hernia, injured limbs, neurological pathology)
- Belenophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study
In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.
In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds
- Conditions
- Lower Back Pain
- Being tested
- NMP
- 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.
NMPOther
Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
| Study group | Role | What they receive |
|---|---|---|
| NMP in level 1 | Experimental | Participants in this group received NMP of the sciatic nerve in the gluteus region Receives: Other: NMP |
| NMP in level 2 | Experimental | Participants in this group received NMP of the sciatic nerve in the middle of the thigh Receives: Other: NMP |
| NMP in level 3 | Experimental | Participants in this group received NMP of the sciatic nerve before popliteus region Receives: Other: NMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Measured: From baseline measurement up to 1 week
Range of motion
Measured by goniometer. Hip flexion, external and internal rotation range of motion
Measured: From baseline measurement up to 1 week
Y Balance Test
Stability body
Measured: From baseline measurement up to 1 week
Owestry questionnaire
Lower back pain questionnaire
Measured: From baseline measurement up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start8 May 2020
- Primary completion9 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de la Cruz Torres, University of Seville
- Investigators
- Blanca De la Cruz Torres, PhD, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347265
- Sponsor's protocol ID
- NMP in lower back pain
- Status last verified
- Oct 2021
- First submitted
- 12 Apr 2020
- Last updated
- 11 Oct 2021
- Results posted
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT04347265
- Acronym / sponsor ID
- NMP in lower back pain
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 9 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 15 Apr 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.
In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.
In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMP in level 1 | Experimental | Other: NMPParticipants in this group received NMP of the sciatic nerve in the gluteus region |
| NMP in level 2 | Experimental | Other: NMPParticipants in this group received NMP of the sciatic nerve in the middle of the thigh |
| NMP in level 3 | Experimental | Other: NMPParticipants in this group received NMP of the sciatic nerve before popliteus region |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Lower Back Pain
- Having no other therapy
Key exclusion criteria (2 listed)
- Other pathology (discal hernia, injured limbs, neurological pathology)
- Belenophobia
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 |
|---|---|---|
| NMPParticipants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention. | Other | NMP in level 1, NMP in level 2, NMP in level 3 |
Primary outcome
Level of pain
Time frame: From baseline measurement up to 1 week
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Range of motion
Time frame: From baseline measurement up to 1 week
Measured by goniometer. Hip flexion, external and internal rotation range of motion
Y Balance Test
Time frame: From baseline measurement up to 1 week
Stability body
Owestry questionnaire
Time frame: From baseline measurement up to 1 week
Lower back pain questionnaire
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 11 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Lower Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Blanca De la Cruz Torres, PhD study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMP in people with Lower Back 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 2 inclusion and 2 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 11 Oct 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. 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?
Level of pain (time frame: From baseline measurement up to 1 week). The study lists 4 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 11 Oct 2021.