Neck Pain TreatmentPhase 1/2NCT02498249
Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain
A Phase 1/2 study testing low level laser therapy in people with Neck Pain Treatment, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain Treatment
- What is being tested?
- low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Jul 2015
- Phase
- Phase 1/2
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years
- Male and female volunteers
- History of neck pain for a period of more than two months
- Score ranging from 15 to 24 on the Neck Disability Index
- Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity
Who cannot join
- history of neurological disorders
- neck surgery
- chronic neck pain resulting from a traumatic incident
- chronic musculoskeletal condition
- medical diagnosis of fibromyalgia; systemic disease
- connective tissue disorder
- having undergone physical therapy use of analgesic, muscle relaxant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain: a Randomized, Double-blinded, Sham-controlled, Crossover Study
The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p < 0.05.
- Conditions
- Neck Pain Treatment
- Being tested
- low level laser therapy, Placebo low level laser therapy
- Keywords
- Low-Level Laser Therapy, trapezius muscle, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyDevice
Will be performed irradiation with low-intensity laser in upper trapezius muscle
Placebo low level laser therapyDevice
Will be not performed irradiation with low-intensity laser in upper trapezius muscle
| Study group | Role | What they receive |
|---|---|---|
| Experimental: low level laser therapy (LLLT) | Experimental | For the LLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the LLLT was determined by the location of the innervation point of the upper trapezius muscle.
Individuals will be subject to application of low level laser with a total dose of 18 J Receives: Device: low level laser therapy |
| Experimental: Placebo low level laser therapy (PLLLT) | Placebo comparator | For the PLLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the PLLLT was determined by the location of the innervation point of the upper trapezius muscle.
Individuals will be subject to application of low level laser with a total dose of 0 J Receives: Device: Placebo low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
Measured: 1 Year
Secondary outcomes (1)
Numerical rating scale score for pain
A numerical rating scale for pain will be used to assess pain intensity in the NS-NP individuals. This is an 11-point scale ranging from 0 (absence of pain) to 10 (worst possible pain). The numerical rating scale was translated and cross-culturally adapted for the Brazilian population.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Pain TreatmentStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Simone Aparecida Penimpedo Calamita, Fabiana Sarilho de Mendonça, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Paulo de Tarso Camilo de Camargo
- Responsible party
- Principal investigator, Prof. Fabiano Politti, FT, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498249
- Sponsor's protocol ID
- U9-2015
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain: a Randomized, Double-blinded, Sham-controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT02498249
- Acronym / sponsor ID
- U9-2015
- Conditions
- Neck Pain Treatment
- Keywords
- Low-Level Laser Therapy, trapezius muscle, neck pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Simone Aparecida Penimpedo Calamita, Fabiana Sarilho de Mendonça, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Paulo de Tarso Camilo de Camargo
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jul 2015 (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.
The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: low level laser therapy (LLLT) | Experimental | Device: low level laser therapyFor the LLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the LLLT was determined by the location of the innervation point of the upper trapezius muscle. Individuals will be subject to application of low level laser with a total dose of 18 J |
| Experimental: Placebo low level laser therapy (PLLLT) | Placebo comparator | Device: Placebo low level laser therapyFor the PLLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the PLLLT was determined by the location of the innervation point of the upper trapezius muscle. Individuals will be subject to application of low level laser with a total dose of 0 J |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 40 years
- Male and female volunteers
- History of neck pain for a period of more than two months
- Score ranging from 15 to 24 on the Neck Disability Index
- Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity
Key exclusion criteria (7 listed)
- history of neurological disorders
- neck surgery
- chronic neck pain resulting from a traumatic incident
- chronic musculoskeletal condition
- medical diagnosis of fibromyalgia; systemic disease
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 |
|---|---|---|
| low level laser therapyWill be performed irradiation with low-intensity laser in upper trapezius muscle | Device | Experimental: low level laser therapy (LLLT) |
| Placebo low level laser therapyWill be not performed irradiation with low-intensity laser in upper trapezius muscle | Device | Experimental: Placebo low level laser therapy (PLLLT) |
Primary outcome
Electromyographic activity
Time frame: 1 Year
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
1 secondary outcome
Numerical rating scale score for pain
Time frame: 1 Year
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 15 Jul 2015.
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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 Phase 1/2 study testing low level laser therapy in people with Neck Pain Treatment, 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 7 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 15 Jul 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Electromyographic activity (time frame: 1 Year). 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 15 Jul 2015.