NCT05753540

Brief Summary

Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is featured by neck muscles contractures which lead to pain and reduction of cervical spine mobility. High intensity laser therapy has been shown to be an effective treatment to improve symothoms in patient with non-specific neck pain. The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

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 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

June 28, 2022

Last Update Submit

May 19, 2023

Conditions

Chronic Non-specific Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Neck pain

    Eleven point (0-10) visual analogue scale

    Change from baseline neck pain at 3 and 7 weeks

Secondary Outcomes (1)

  • Change in Disability

    Change from baseline disability at 3 and 7 weeks

Other Outcomes (1)

  • Change in Neck mobility

    Change from baseline neck mobility at 3 and 7 weeks

Study Arms (2)

Laser therapy

EXPERIMENTAL

Multiwave locked system laser therapy

Other: Laser therapy

Sham laser therapy

PLACEBO COMPARATOR

Sham laser therapy

Other: Sham laser therapy

Interventions

Laser therapyOTHER

Multiwave locked system 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)
  • 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
  • Upper limbs radiculopathy
  • Cervical rib
  • Rotator cuff or other shoulder diseases
  • Rheumatic diseases
  • Diabetes
  • Psychiatric diseases
  • Vascular diseases
  • Cancer
  • Infectious diseases
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant

Study Record Dates

First Submitted

June 28, 2022

First Posted

March 3, 2023

Study Start

March 21, 2022

Primary Completion

November 11, 2022

Study Completion

March 31, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

IT(1)