Non-specific Low Back PainMLSLASERlumbNCT05870826
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Low Back Pain
A study testing Multiwave locked system laser therapy in people with Non-specific Low Back Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Non-specific cronic low back pain is very common condition affecting 80-85% of adults. The most common therapies for low back pain are: patient education, excercise and physical therapy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Multiwave locked system laser therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2022to 21 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain (> 3 months)
- Lack of effectivness of previous conservative therapies for low back pain
- Body mass index < 30
- Preserved cognitive ability to fully understand and observe indications received by medical personnel
- Ability to understand and give an informed consent
Who cannot join
- Spine surgery
- Spinal hernia
- spondylolisthesis
- Spinal infections
- Severe spine deformities
- Neural diseases
Show all 29Show fewer
- Rheumatic diseases
- Diabetes
- Psychiatric diseases
- Vascular diseases
- Cancer
- Infectious diseases
- Kidney stones
- Skin abrasion
- Pregnancy or breastfeeding
- Recent injuries
- Known sensibility to Laser therapy
- Epilepsy
- Anticoagulant therapy
- Pacemaker
- hemorrhagic diathesis
- Photosensitizing drugs
- Kown Photosensibility
- Low back Tattoos
- Steroid injections in the previous 3 weeks
- Antinflammatory or pain drugs
- HIV positive
- Neuro-stimulation implanted systems
- Tissue with ischemia in the low back
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Low Back Pain: Randomized Controlled Trial Versus Placebo
Non-specific cronic low back pain is very common condition affecting 80-85% of adults. The most common therapies for low back pain are: patient education, excercise and physical therapy. High intensity laser therapy has been shown to be an effective treatment to improve sympthoms in patient with non-specific low back pain when combined wth exercise.
The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif low back pain when administered alone.
Read the detailed description
Chronic nonspecific low back pain, given its high prevalence globally and the disability resulting from it, results in significant deterioration in quality of life and substantial both social and economic costs. The determinants are predominantly biological, in particular musculoskeletal alterations of the lumbar region, but psychosocial factors also contribute significantly to the manifestation of the disorder.
Patients with chronic nonspecific low back pain are characterized by pain intensity sometimes disabling, a reduction in lumbar range of motion (ROM) and the frequent absence of flexion-relaxation phenomenon (FRP). Both high-power and low-power laser therapy, especially when included in a multidimensional rehabilitation plan, seems effective in improving both pain and function of affected patients. MLS (Multiwave Locked System) laser therapy is an innovative high-power technology characterized by the combined and synchronized emission of laser light at two wavelengths (a continuous emission with a wavelength wavelength of 808 nm and a pulsed emission at 905 nm) and its efficacy in the treatment of chronic nonspecific low back pain is still unknown.
This work aims to study the effects of MSL laser therapy on pain, disability disability, lumbar ROM and muscle activity in a homogeneous group of patients with from chronic nonspecific low back pain. Although the literature shows that the combination of exercise with laser therapy yields better results in terms of both pain reduction and functional recovery, in this study we chose not to use any combination of treatments, in order to evaluate the effectiveness of MLS laser therapy alone in the treatment of chronic nonspecific low back pain.
To isolate the specific results of MLS laser therapy, it is intended to compare it with a placebo, represented by a device apparently identical in morphology and behavior to that delivering the laser and emitting visible light of similar appearance, by means of a clinical trial double-blind prospective randomized controlled trial. The double-blind design is adhered to because the type of laser therapy employed with the protocol followed, despite the effects tissue biology highlighted in the literature, is not able to make the patient feel any heat sensation during the session. 31 This is the first study in the literature aimed at analyzing the possible effects determined by the use of MLS laser therapy in chronic nonspecific low back pain: this investigation is conducted with an integrated methodology, using standardized and validated measures for pain intensity and disability, combined with kinematic and electromyography of high technological value.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Multiwave locked system laser therapy, Sham laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiwave locked system laser therapyOther
High intensity laser therapy
Sham laser therapyOther
Sham laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Sham laser therapy | Sham comparator | The control group (PL group) is subjected to a laser sham (placebo), employing a device identical to the one under investigation but lacking the laser emission capability, and the same mode of administration in terms of time and place. Both the sham laser and the test device emit visible light of the same color and are not distinguishable in any way. Receives: Other: Sham laser therapy |
| Laser therapy | Experimental | The MLS group receives MLS synchronized diode laser therapy emitted by the MLS M8 robotic device (ASA, Italy).
MLS M8 (ASA, Arcugnano, Italy), a Class IV (high-power) laser approved by the Food Drug Administration (FDA) and CE certified, characterized by a combined, synchronized two-wavelength (CPW) emission: a continuous emission with a wavelength of 808 nm and a pulsed emission at 905 nm.
The duration of each session is 5 min 45 sec.seconds, delivering a total energy of 1500 J and an energy dose of 5 J/cm2, for an area of 300 cm2.
The robotic device is placed in the lumbar area, oriented on the muscles erector spinae and quadratus lumborum. The target area set on the device is "lumbar area." The parameters set on the device are "Synchronized Emission of Continuous Pulsed Wave (CPW)," "intensity of 100%," "time of 5 minutes and 45 seconds," and "area of 1x300 cm2." Receives: Other: Multiwave locked system laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
Measured: At baseline (T0)
Low back pain
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
Measured: 3 weeks (T1)
Low back pain
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
Measured: One month by the end of the intervention (T2)
Secondary outcomes (6)
Disability
Roland-Morris questionnaire
Measured: At baseline (T0)
Disability
Roland-Morris questionnaire
Measured: 3 weeks (T1)
Disability
Roland-Morris questionnaire
Measured: One month by the end of the intervention (T2)
Pain and Disability
Oswestry disability questionnaire
Measured: At baseline (T0)
Pain and Disability
Oswestry disability questionnaire
Measured: 3 weeks (T1)
Pain and Disability
Oswestry disability questionnaire
Measured: One month by the end of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start21 Mar 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariagrazia Benedetti, Istituto Ortopedico Rizzoli
- Investigators
- Maria Grazia Benedetti, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870826
- Sponsor's protocol ID
- 0012596
- Acronym
- MLSLASERlumb
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 25 May 2023
- 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Low Back Pain: Randomized Controlled Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT05870826
- Acronym / sponsor ID
- MLSLASERlumb / 0012596
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 23 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.
Non-specific cronic low back pain is very common condition affecting 80-85% of adults. The most common therapies for low back pain are: patient education, excercise and physical therapy. High intensity laser therapy has been shown to be an effective treatment to improve sympthoms in patient with non-specific low back pain when combined wth exercise.
The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif low back pain when administered alone.
Detailed description
Chronic nonspecific low back pain, given its high prevalence globally and the disability resulting from it, results in significant deterioration in quality of life and substantial both social and economic costs. The determinants are predominantly biological, in particular musculoskeletal alterations of the lumbar region, but psychosocial factors also contribute significantly to the manifestation of the disorder.
Patients with chronic nonspecific low back pain are characterized by pain intensity sometimes disabling, a reduction in lumbar range of motion (ROM) and the frequent absence of flexion-relaxation phenomenon (FRP). Both high-power and low-power laser therapy, especially when included in a multidimensional rehabilitation plan, seems effective in improving both pain and function of affected patients. MLS (Multiwave Locked System) laser therapy is an innovative high-power technology characterized by the combined and synchronized emission of laser light at two wavelengths (a continuous emission with a wavelength wavelength of 808 nm and a pulsed emission at 905 nm) and its efficacy in the treatment of chronic nonspecific low back pain is still unknown.
This work aims to study the effects of MSL laser therapy on pain, disability disability, lumbar ROM and muscle activity in a homogeneous group of patients with from chronic nonspecific low back pain. Although the literature shows that the combination of exercise with laser therapy yields better results in terms of both pain reduction and functional recovery, in this study we chose not to use any combination of treatments, in order to evaluate the effectiveness of MLS laser therapy alone in the treatment of chronic nonspecific low back pain.
To isolate the specific results of MLS laser therapy, it is intended to compare it with a placebo, represented by a device apparently identical in morphology and behavior to that delivering the laser and emitting visible light of similar appearance, by means of a clinical trial double-blind prospective randomized controlled trial. The double-blind design is adhered to because the type of laser therapy employed with the protocol followed, despite the effects tissue biology highlighted in the literature, is not able to make the patient feel any heat sensation during the session. 31 This is the first study in the literature aimed at analyzing the possible effects determined by the use of MLS laser therapy in chronic nonspecific low back pain: this investigation is conducted with an integrated methodology, using standardized and validated measures for pain intensity and disability, combined with kinematic and electromyography of high technological value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham laser therapy | Sham comparator | Other: Sham laser therapyThe control group (PL group) is subjected to a laser sham (placebo), employing a device identical to the one under investigation but lacking the laser emission capability, and the same mode of administration in terms of time and place. Both the sham laser and the test device emit visible light of the same color and are not distinguishable in any way. |
| Laser therapy | Experimental | Other: Multiwave locked system laser therapyThe MLS group receives MLS synchronized diode laser therapy emitted by the MLS M8 robotic device (ASA, Italy). MLS M8 (ASA, Arcugnano, Italy), a Class IV (high-power) laser approved by the Food Drug Administration (FDA) and CE certified, characterized by a combined, synchronized two-wavelength (CPW) emission: a continuous emission with a wavelength of 808 nm and a pulsed emission at 905 nm. The duration of each session is 5 min 45 sec.seconds, delivering a total energy of 1500 J and an energy dose of 5 J/cm2, for an area of 300 cm2. The robotic device is placed in the lumbar area, oriented on the muscles erector spinae and quadratus lumborum. The target area set on the device is "lumbar area." The parameters set on the device are "Synchronized Emission of Continuous Pulsed Wave (CPW)," "intensity of 100%," "time of 5 minutes and 45 seconds," and "area of 1x300 cm2." |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic low back pain (> 3 months)
- Lack of effectivness of previous conservative therapies for low back pain
- Body mass index < 30
- Preserved cognitive ability to fully understand and observe indications received by medical personnel
- Ability to understand and give an informed consent
Key exclusion criteria (29 listed)
- Spine surgery
- Spinal hernia
- spondylolisthesis
- Spinal infections
- Severe spine deformities
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 |
|---|---|---|
| Multiwave locked system laser therapyHigh intensity laser therapy | Other | Laser therapy |
| Sham laser therapySham laser therapy | Other | Sham laser therapy |
Primary outcome
Low back pain
Time frame: At baseline (T0)
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
Low back pain
Time frame: 3 weeks (T1)
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
Low back pain
Time frame: One month by the end of the intervention (T2)
VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)
6 secondary outcomes
Disability
Time frame: At baseline (T0)
Disability
Time frame: 3 weeks (T1)
Disability
Time frame: One month by the end of the intervention (T2)
Pain and Disability
Time frame: At baseline (T0)
Pain and Disability
Time frame: 3 weeks (T1)
Pain and Disability
Time frame: One month by the end of the intervention (T2)
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 May 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.
Maria Grazia Benedetti principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiwave locked system laser therapy in people with Non-specific Low Back Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 5 inclusion and 29 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 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 Italy. 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?
Low back pain (time frame: At baseline (T0)). 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 25 May 2023.