Chronic Non-specific Neck PainNCT05753540
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain
A study testing Laser therapy in people with Chronic Non-specific Neck Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- Laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Spine surgery
- Spinal hernia
- spondylolisthesis
- Spinal infections
- Severe spine deformities
- Neural diseases
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Non-specific Neck Pain
- Being tested
- Laser therapy, Sham laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyOther
Multiwave locked system laser therapy
Sham laser therapyOther
Sham laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | Multiwave locked system laser therapy Receives: Other: Laser therapy |
| Sham laser therapy | Placebo comparator | Sham laser therapy Receives: Other: Sham laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck pain
Eleven point (0-10) visual analogue scale
Measured: Change from baseline neck pain at 3 and 7 weeks
Secondary outcomes (1)
Change in Disability
Neck disability index questionnaire
Measured: Change from baseline disability at 3 and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start21 Mar 2022
- Primary completion11 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Neck PainStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Berti, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753540
- Sponsor's protocol ID
- MLS LASER-neck
- Status last verified
- May 2023
- First submitted
- 28 Jun 2022
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05753540
- Acronym / sponsor ID
- MLS LASER-neck
- Conditions
- Chronic Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Other: Laser therapyMultiwave locked system laser therapy |
| Sham laser therapy | Placebo comparator | Other: Sham laser therapySham laser therapy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- Spine surgery
- Spinal hernia
- spondylolisthesis
- Spinal infections
- Severe spine deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapyMultiwave locked system laser therapy | Other | Laser therapy |
| Sham laser therapySham laser therapy | Other | Sham laser therapy |
Primary outcome
Change in Neck pain
Time frame: Change from baseline neck pain at 3 and 7 weeks
Eleven point (0-10) visual analogue scale
1 secondary outcome
Change in Disability
Time frame: Change from baseline disability at 3 and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Chronic Non-specific Neck Pain, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck pain (time frame: Change from baseline neck pain at 3 and 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.