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

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05753540
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Non-specific Neck Pain	Other: Laser therapy; Other: Sham laser therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Mar 21, 2023
• Anticipated Study Completion Date: Apr 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser therapy Multiwave locked system laser therapy	Other: Laser therapy; Multiwave locked system laser therapy
Placebo Comparator: Sham laser therapy Sham laser therapy	Other: Sham laser therapy; Sham laser therapy

Outcome Measures

Primary Outcome Measures

1. Change in Neck pain [Change from baseline neck pain at 3 and 7 weeks]

   Eleven point (0-10) visual analogue scale

Secondary Outcome Measures

1. Change in Disability [Change from baseline disability at 3 and 7 weeks]

   Neck disability index questionnaire

Other Outcome Measures

1. Change in Neck mobility [Change from baseline neck mobility at 3 and 7 weeks]

   Degree of head rigth/left flexion, forward/backward flexion and rigth/left rotation, together with the velocity of the movements measured with an accelerometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa Berti, Assistant, Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT05753540
• Other Study ID Numbers: MLS LASER-neck
• First Posted: Mar 3, 2023
• Last Update Posted: Mar 3, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of Mar 3, 2023