Neck PainNCT02940119

Neck and Shoulder Pain Research Study

A study testing Multi Radiance Medical® in people with Neck Pain and Shoulder Pain, run by University of Nove de Julho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant number of individuals.The aim of this study is to evaluate the effects of PBMT (with a device that combines low level laser therapy and light emitting diode therapy) in chronic pain relief of musculoskeletal origin in the neck and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neck Pain, Shoulder Pain, Chronic Pain
What is being tested?: Multi Radiance Medical®
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteBrazil
Study dates: Nov 2016to Apr 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

presenting primary pain is located in the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
neck and/or shoulder pain is of benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms;
neck/shoulder pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is 50 or greater;
subject is willing and able to maintain his or her current pre-study neck/shoulder pain management regimen of pain relief medication and/or treatment/therapy use throughout the course of study duration, whilst refraining from consuming other types of medication and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants, and/or partaking in other treatments/therapies including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.

Who cannot join

subject's presenting primary pain is located outside or in addition to the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
subject's neck and/or shoulder pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms, and/or the etiology of the subject's neck/shoulder pain cannot be satisfactorily ruled out as one or more;
neck/shoulder pain is acute, defined as having persisted over less than the last 3 months;
neck/shoulder pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is less than 50;
local corticosteroids and/or botulinum toxin (Botox®) injection for neck/shoulder pain relief within the prior 30 days;

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such as chiropractic care and acupuncture;
current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord, diabetes Type 1, significant heart conditions including coronary heart failure and implantable heart devices such as a pacemaker, active infection, wound or other external trauma to the areas to be treated with the laser, surgery to the neck and/or shoulder region in the past 12 months;
medical, physical, or other contraindications for, or sensitivity to, light therapy;
pregnant, breast feeding, or planning pregnancy prior to the end of study participation, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;
developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements;
involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study;
subject is less than 18 years of age;
participation in a clinical study or other type of research in the past 30 days.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)
São Paulo, São Paulo, 01504-001

Other trials in Brazil

About this study

Official title: Effects of Phototherapy With Different Sources of Light in Muscle Skeletal Chronic Pain Relief From Neck and Shoulders

Read the detailed description

Randomized, placebo-controlled, double-blind clinical trial was carried out. Seventy-two patients with chronic pain in neck and shoulder were recruited and randomized into two groups (n = 36 each group), one group received active PBMT and another group received placebo PBMT (with a device with same appearance of the actual laser, including any visible light). Patients were treated at 9 different sites of 3 zones in the neck and shoulders area, twice a week during 3 consecutive weeks with a PBMT device manufactured by Multi Radiance Medical™ (Solon - OH, USA). Primary outcome was intensity of pain using the Visual Analog Pain Scale (VAS), secondary outcomes were range of motion (ROM) of the neck and shoulders and patient satisfaction with therapy employed.

Sample Size calculation: The success criterion was defined as a 30% or greater reduction in VAS from baseline to the final evaluation and overall efficacy of the PBMT/sMF therapy was considered successful if a minimal difference of 35% is found between the active and placebo group. It was anticipated that about 55% of subjects in the active group and about 20% of subjects in the placebo group would meet the individual success criteria and intended application of a two-tailored test with an alpha of 0.05 and power of 0.8.

A sample size of 33 eligible subjects per group was calculation31 and a subject loss-to-follow-up of 10% was anticipated to bring the sample size to 36 subjects in each group. To ensure statistically valid and representative data of the general population sampled, a total of 72 subjects were enrolled in this study and stratified by Fitzpatrick skin type as following: Lighter skinned individuals were into Fitzpatrick skin types I, II and III, while darker skinned individuals were into Fitzpatrick skin types IV, V and VI.

Conditions: Neck Pain, Shoulder Pain, Chronic Pain, Musculoskeletal Pain
Being tested: Multi Radiance Medical®
Medical subject headings: Neck Pain, Shoulder Pain, Chronic Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multi Radiance Medical®Device
Also called Photobiomodulation therapy
Volunteers received all procedures of the study with active or placebo phototherapy (PBMT) in 9 sites of the neck and shoulders, twice a week. The PBMT was applied in all sessions.

Study groups in NCT02940119
Study group	Role	What they receive
Active PBMT	Active comparator	The volunteers received active phototherapy in each session. Receives: Device: Multi Radiance Medical®
Placebo PBMT	Placebo comparator	The volunteers received placebo phototherapy in each session. Receives: Device: Multi Radiance Medical®

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain assessment
Visual anagogic scale (VAS)
Measured: one month

Secondary outcomes (2)

Rage of Motion (ROM)
pre-defined assessment with a goniometer
Measured: one month
Individualized pain management regimen
questionnaire about perception and what kind of phototherapy was performed (active or placebo). This assessment was answered by subjects, investigator that performed the assessments and investigator that performed phototherapy application.
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Apr 2017

First posted20 Oct 2016 (estimated)
Study startNov 2016
Primary completionMar 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neck PainStudies of the same condition, open and under way.
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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02940119
Sponsor's protocol ID: 041016
Status last verified: Jul 2020
First submitted: 4 Oct 2016
Last updated: 14 Jul 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Phototherapy With Different Sources of Light in Muscle Skeletal Chronic Pain Relief From Neck and Shoulders
ClinicalTrials.gov ID: NCT02940119
Acronym / sponsor ID: 041016
Conditions: Neck Pain, Shoulder Pain, Chronic Pain, Musculoskeletal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of Nove de JulhoUniversity, hospital or other
Study start: Nov 2016 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 20 Oct 2016 (estimated)
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.

Detailed description

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
Active PBMT	Active comparator	Device: Multi Radiance Medical®The volunteers received active phototherapy in each session.
Placebo PBMT	Placebo comparator	Device: Multi Radiance Medical®The volunteers received placebo phototherapy in each session.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

presenting primary pain is located in the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
neck and/or shoulder pain is of benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms;
neck/shoulder pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is 50 or greater;
subject is willing and able to maintain his or her current pre-study neck/shoulder pain management regimen of pain relief medication and/or treatment/therapy use throughout the course of study duration, whilst refraining from consuming other types of medication and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants, and/or partaking in other treatments/therapies including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.

Key exclusion criteria (15 listed)

subject's presenting primary pain is located outside or in addition to the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
subject's neck and/or shoulder pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms, and/or the etiology of the subject's neck/shoulder pain cannot be satisfactorily ruled out as one or more;
neck/shoulder pain is acute, defined as having persisted over less than the last 3 months;
neck/shoulder pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is less than 50;

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
Multi Radiance Medical®Also: Photobiomodulation therapyVolunteers received all procedures of the study with active or placebo phototherapy (PBMT) in 9 sites of the neck and shoulders, twice a week. The PBMT was applied in all sessions.	Device	Active PBMT, Placebo PBMT

Primary outcome

Pain assessment
Time frame: one month
Visual anagogic scale (VAS)

2 secondary outcomes

Rage of Motion (ROM)
Time frame: one month
Individualized pain management regimen
Time frame: one month

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 14 Jul 2020.

Related trials for Neck Pain

Not yet recruiting
Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparative Effects of Exercises on Pain, Cervical Proprioception, Neck Disability and Visual Performance in Patients With Computer Vision Syndrome.
Computer Vision Syndrome
Not yet recruiting
The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain
Chronic Neck Pain
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Effects of Progressive Neck Motor Control Exercises With and Without Conventional Therapy in Text Neck Syndrome.(PNMCE-TNS)
Text Neck Syndrome

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.

Ernesto Leal-Junior, PhD principal investigator

University of Nove de Julho

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multi Radiance Medical® in people with Neck Pain and Shoulder Pain, run by University of Nove de Julho at 1 site in Brazil.

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 5 inclusion and 15 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 14 Jul 2020. 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 Brazil. 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?

Pain assessment (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940119.

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 14 Jul 2020.