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

Chronic Non-specific Neck Pain Clinical Trial

Official title:

Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial Versus Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753540
• Other study ID #: MLS LASER-neck
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 31, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Non-specific Neck Pain
• Neck Pain

Intervention

Other:
• Laser therapy
Multiwave locked system laser therapy
• Sham laser therapy
Sham laser therapy

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Change in Neck pain	Eleven point (0-10) visual analogue scale	Change from baseline neck pain at 3 and 7 weeks
Secondary	Change in Disability	Neck disability index questionnaire	Change from baseline disability at 3 and 7 weeks