Clinical trial NCT05870826: The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Spine surgery
* Spinal hernia
* spondylolisthesis
* Spinal infections
* Severe spine deformities
* Neural diseases
* 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

Primary outcomes:
measure: Low back pain
timeFrame: At baseline (T0)
measure: Low back pain
timeFrame: 3 weeks (T1)
measure: Low back pain
timeFrame: One month by the end of the intervention (T2)
Secondary outcomes:
measure: Disability
timeFrame: At baseline (T0)
measure: Disability
timeFrame: 3 weeks (T1)
measure: Disability
timeFrame: One month by the end of the intervention (T2)
measure: Pain and Disability
timeFrame: At baseline (T0)
measure: Pain and Disability
timeFrame: 3 weeks (T1)
measure: Pain and Disability
timeFrame: One month by the end of the intervention (T2)
Other outcomes:
measure: Trunk kinematics
timeFrame: At baseline (T0)
measure: Trunk kinematics
timeFrame: 3 weeks (T1)
measure: Trunk kinematics
timeFrame: One month by the end of the intervention (T2)
measure: Low back muscles activation
timeFrame: At baseline (T0)
measure: Low back muscles activation
timeFrame: 3 weeks (T1)
measure: Low back muscles activation
timeFrame: One month by the end of the intervention (T2)
Locations:
city: Bologna
country: Italy
facility: IRCCS-Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Maria Grazia Benedetti
role: PRINCIPAL_INVESTIGATOR
References: