The Effects of MLS LASER Therapy in Patients With Chronic... | NCT05753540

Studies
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain

NCT05753540

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

May 22, 2023Actual

Enrollment

47Actual

Phase

Not Applicable

Conditions

Chronic Non-specific Neck Pain

Interventions

Laser therapy
Sham laser therapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Actual

Primary Completion Date

Nov 11, 2022Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Jun 28, 2022

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2023

Last Update Posted Date

May 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser therapy	Experimental	Multiwave locked system laser therapy	Other: Laser therapy
Sham laser therapy	Placebo Comparator	Sham laser therapy	Other: Sham laser therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser therapy	Other	Multiwave locked system laser therapy	Laser therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Neck pain	Eleven point (0-10) visual analogue scale	Change from baseline neck pain at 3 and 7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Disability	Neck disability index questionnaire	Change from baseline disability at 3 and 7 weeks

Other Outcomes

Measure	Description	Time Frame
Change in Neck mobility	Degree of head rigth/left flexion, forward/backward flexion and rigth/left rotation, together with the velocity of the movements measured with an accelerometer	Change from baseline neck mobility at 3 and 7 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Skin abrasion
Pregnancy or breastfeeding
Recent injuries
Known sensibility to Laser therapy
Epilepsy
Anticoagulant therapy
Pacemaker
hemorrhagic diathesis
Photosensitizing drugs
Known Photosensibility
Neck Tattoos

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Rizzoli		Bologna		40136	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided