NCT05870826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

June 27, 2022

Last Update Submit

May 23, 2023

Conditions

Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • Low back pain

    VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)

    At baseline (T0)

  • Low back pain

    VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)

    3 weeks (T1)

  • Low back pain

    VAS, Visual Analogic Scale minimum 0 (the best) and maximum 10 (the worst)

    One month by the end of the intervention (T2)

Secondary Outcomes (6)

  • Disability

    At baseline (T0)

  • Disability

    3 weeks (T1)

  • Disability

    One month by the end of the intervention (T2)

  • Pain and Disability

    At baseline (T0)

  • Pain and Disability

    3 weeks (T1)

  • +1 more secondary outcomes

Other Outcomes (6)

  • Trunk kinematics

    At baseline (T0)

  • Trunk kinematics

    3 weeks (T1)

  • Trunk kinematics

    One month by the end of the intervention (T2)

  • +3 more other outcomes

Study Arms (2)

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.

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."

Other: Multiwave locked system laser therapy

Interventions

Multiwave locked system laser therapyOTHER

High intensity laser therapy

Laser therapy
Sham laser therapyOTHER

Sham laser therapy

Sham laser therapy

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS-Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Study Officials

  • Maria Grazia Benedetti

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Unit of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

June 27, 2022

First Posted

May 23, 2023

Study Start

March 21, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

IT(1)