Chronic Neck PainNCT04020861
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
A study testing Active PBM and Active TENS in people with Chronic Neck Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Active PBM and Active TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jan 2020to 25 Jul 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;
- Neck pain for at least 3 months;
- Neck Disability Index (NDI) score of 5 points or higher;
- Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;
- Aged between 18 and 65 years;
- Men and women
Who cannot join
- Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);
- Previous spinal surgery;
- Patients treated with physical therapy for neck pain in the last 3 months previous the study;
- Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;
- Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;
- Rheumatic, metabolic, neurological or cardiopulmonary diseases;
Show all 11Show fewer
- Patients who require artificial cardiac pacemakers;
- Skin diseases, mainly at the current application site;
- Tumors or cancer historic in the last 5 years;
- Pregnancy;
- If the patient started any physical activity in the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.
Read the detailed description
Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.
- Conditions
- Chronic Neck Pain
- Being tested
- Active PBM, Active TENS, Placebo PBM, Placebo TENS
- Keywords
- Electrophysical agents, Low-level laser therapy, TENS, Neck pain, Chronic pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMDevice
To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.
Active TENSDevice
To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.
Placebo PBMDevice
In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.
Placebo TENSDevice
To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.
| Study group | Role | What they receive |
|---|---|---|
| PBM + TENS | Active comparator | The patients will be submitted to the active PBM and active TENS Receives: Device: Active PBM; Device: Active TENS |
| PBM | Active comparator | The patients will be submitted to the active PBMT and placebo TENS Receives: Device: Active PBM; Device: Placebo TENS |
| TENS | Active comparator | The patients will be submitted to the placebo PBMT and active TENS Receives: Device: Active TENS; Device: Placebo PBM |
| Placebo | Placebo comparator | The patients will be submitted to the placebo PBMT and placebo TENS. Receives: Device: Placebo PBM; Device: Placebo TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: Numerical Rating Scale (Pain NRS)
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.
Measured: 2 weeks after randomization
Secondary outcomes (12)
Pain intensity: Numerical Rating Scale (Pain NRS)
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.
Measured: 6 weeks after randomization
Pain intensity at movement: Numerical Rating Scale (Pain NRS)
Pain intensity will be evaluated during the cervical movements of flexion, extension, right and left lateral inclination and right and left rotation, using an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Measured: 2 weeks after randomization
Neck disability
Neck disability will be evaluated using neck disability index (NDI) that consists of a 10-item questionnaire that assess the impact of pain on daily activities using a score from 0 to 5 for each section, with higher values indicating more severe impact.
Measured: 2 weeks after randomization
Cervical range of motion
Cervical range of motion will be measured with a fleximeter
Measured: 2 weeks after randomization
Pressure Pain Threshold
Pressure pain threshold (PPT) in the neck, shoulder girdle and anterior tibialis muscle will be measured using a Somedic Type II pressure algometer
Measured: 2 weeks after randomization
Pain temporal summation (TS)
Temporal summation (TS) will be induced by a pressure algometer. Ten (10) stimuli with a pressure of 40 kPa/s of the mean value of algometry performed prior on the upper trapezius. Patients will be asked about their pain using NRS at the first, fifth and tenth stimulus.
Measured: 2 weeks after randomization
Conditioned pain modulation (CPM)
The conditioned stimulus for eliciting CPM will be the cold pressor test (Cold Water Bath test to the hand) and the test stimulus will be the assessment of PPT on the upper trapezius muscle.
Measured: 2 weeks after randomization
Depressive symptoms
The depressive symptoms will be performed using Beck Depression Inventory (BDI). The scale consists of items including symptoms and attitudes whose intensity range from neutral to a maximum level of severity, rated from 0 to 3.
Measured: 2 weeks after randomization
Pain catastrophizing
Pain catastrophizing will be performed with Pain Catastrophizing Scale (PCS) - The PCS is a self-administered questionnaire that consists of 13 items to assess catastrophizers. The items are rated on a 5-point Likert-type scale in which both intensity and frequency information are represented, with the following five levels of response for each Likert item: (0) not at all, (1) to a slight degree, (3) to a moderate degree, (4) to a great degree, (5) and all the time. The total score is computed by summation of all items and the total score ranges from 0 to 52 points. Higher scores indicate greater catastrophic pain.
Measured: 2 weeks after randomization
Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)
The quality of life will be performed using 12-Item Short-Form Health Survey (SF-12) version 2 questionnaire. This is a self-report measure that assesses physical (Physical Component Summary - PCS) and mental (Mental Component Summary - MCS) health on a scale of 0 - 100. Higher scores represent better levels of quality of life.
Measured: 2 weeks after randomization
Analgesic intake
Anlgesic intake will be evaluated asking to the patients all analgesic medications (opioids and non-opioids) taken one week prior to evaluation and during the treatment.
Measured: 2 weeks after randomization
Global perceived effect (GPE)
Global perceived effect will be evaluated by an 11 - point (- 5 to + 5) Global Perceived Effect Scale. It consists of an 11-point scale that ranges from -5 (vastly worse) through 0 (no change) to 5 (completely recovered).
Measured: 2 weeks and 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start6 Jan 2020
- Primary completion25 Jun 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Richard Eloin Liebano, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020861
- Sponsor's protocol ID
- CAAE: 81711417.0.0000.5504
- Status last verified
- Jun 2021
- First submitted
- 5 Jul 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon requested of principal investigator.
Publications
Rampazo EP, de Andrade ALM, da Silva VR, Back CGN, Liebano RE. Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19191. doi: 10.1097/MD.0000000000019191.
PubMed 32080103
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
- ClinicalTrials.gov ID
- NCT04020861
- Acronym / sponsor ID
- CAAE: 81711417.0.0000.5504
- Conditions
- Chronic Neck Pain
- Keywords
- Electrophysical agents, Low-level laser therapy, TENS, Neck pain, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 16 Jul 2019 (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.
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.
Detailed description
Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBM + TENS | Active comparator | Device: Active PBM, Device: Active TENSThe patients will be submitted to the active PBM and active TENS |
| PBM | Active comparator | Device: Active PBM, Device: Placebo TENSThe patients will be submitted to the active PBMT and placebo TENS |
| TENS | Active comparator | Device: Active TENS, Device: Placebo PBMThe patients will be submitted to the placebo PBMT and active TENS |
| Placebo | Placebo comparator | Device: Placebo PBM, Device: Placebo TENSThe patients will be submitted to the placebo PBMT and placebo TENS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;
- Neck pain for at least 3 months;
- Neck Disability Index (NDI) score of 5 points or higher;
- Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;
- Aged between 18 and 65 years;
Key exclusion criteria (11 listed)
- Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);
- Previous spinal surgery;
- Patients treated with physical therapy for neck pain in the last 3 months previous the study;
- Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;
- Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;
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 |
|---|---|---|
| Active PBMTo active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied. | Device | PBM, PBM + TENS |
| Active TENSTo active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia. | Device | PBM + TENS, TENS |
| Placebo PBMIn the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied. | Device | Placebo, TENS |
| Placebo TENSTo placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings. | Device | PBM, Placebo |
Primary outcome
Pain intensity: Numerical Rating Scale (Pain NRS)
Time frame: 2 weeks after randomization
Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.
12 secondary outcomes
Pain intensity: Numerical Rating Scale (Pain NRS)
Time frame: 6 weeks after randomization
Pain intensity at movement: Numerical Rating Scale (Pain NRS)
Time frame: 2 weeks after randomization
Neck disability
Time frame: 2 weeks after randomization
Cervical range of motion
Time frame: 2 weeks after randomization
Pressure Pain Threshold
Time frame: 2 weeks after randomization
Pain temporal summation (TS)
Time frame: 2 weeks after randomization
Conditioned pain modulation (CPM)
Time frame: 2 weeks after randomization
Depressive symptoms
Time frame: 2 weeks after randomization
Pain catastrophizing
Time frame: 2 weeks after randomization
Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)
Time frame: 2 weeks after randomization
Analgesic intake
Time frame: 2 weeks after randomization
Global perceived effect (GPE)
Time frame: 2 weeks and 6 weeks after randomization
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 5 Sep 2021.
- Derived from this study: PubMed 32080103Rampazo EP, de Andrade ALM, da Silva VR, Back CGN, Liebano RE. Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19191. doi: 10.1097/MD.0000000000019191.
- Individual participant dataSharing planned: Yes. The data will be available upon requested of principal investigator.
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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 Active PBM and Active TENS in people with Chronic Neck Pain, run by Universidade Federal de Sao Carlos 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 6 inclusion and 11 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 5 Sep 2021. 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 intensity: Numerical Rating Scale (Pain NRS) (time frame: 2 weeks after randomization). 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 NCT04020861, which also lists 1 linked publication.
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 5 Sep 2021.