Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Laser and Electrical Stimulation on Chronic Neck Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04020861
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Richard Eloin Liebano, Universidade Federal de Sao Carlos

Brief Summary:
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.

Condition or disease Intervention/treatment Phase
Chronic Neck Pain Device: Active PBM Device: Active TENS Device: Placebo PBM Device: Placebo TENS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients: a Protocol of a Randomized Clinical Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PBM + TENS
The patients will be submitted to the active PBM and active TENS
Device: Active PBM
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.

Device: Active TENS
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.

Active Comparator: PBM
The patients will be submitted to the active PBMT and placebo TENS
Device: Active PBM
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.

Device: Placebo TENS
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.

Active Comparator: TENS
The patients will be submitted to the placebo PBMT and active TENS
Device: Active TENS
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.

Device: Placebo PBM
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 Comparator: Placebo
The patients will be submitted to the placebo PBMT and placebo TENS.
Device: Placebo PBM
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: Placebo TENS
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain intensity: Numerical Rating Scale (Pain NRS) [ Time Frame: 6 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.

  2. Pain intensity at movement: Numerical Rating Scale (Pain NRS) [ Time Frame: 2 weeks after randomization ]
    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)

  3. Neck disability [ Time Frame: 2 weeks after randomization ]
    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.

  4. Cervical range of motion [ Time Frame: 2 weeks after randomization ]
    Cervical range of motion will be measured with a fleximeter

  5. Pressure Pain Threshold [ Time Frame: 2 weeks after randomization ]
    Pressure pain threshold (PPT) in the neck, shoulder girdle and anterior tibialis muscle will be measured using a Somedic Type II pressure algometer

  6. Pain temporal summation (TS) [ Time Frame: 2 weeks after randomization ]
    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.

  7. Conditioned pain modulation (CPM) [ Time Frame: 2 weeks after randomization ]
    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.

  8. Depressive symptoms [ Time Frame: 2 weeks after randomization ]
    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.

  9. Pain catastrophizing [ Time Frame: 2 weeks after randomization ]
    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.

  10. Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12) [ Time Frame: 2 weeks after randomization ]
    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.

  11. Analgesic intake [ Time Frame: 2 weeks after randomization ]
    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.

  12. Global perceived effect (GPE) [ Time Frame: 2 weeks and 6 weeks after randomization ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020861


Contacts
Layout table for location contacts
Contact: Richard E Liebano, PhD +5516988692535 liebano@gmail.com
Contact: Érika P Rampazo da Silva, Ms +5516988692535 erika.rampazo@gmail.com

Sponsors and Collaborators
Universidade Federal de Sao Carlos
Fundação de Amparo à Pesquisa do Estado de São Paulo

Layout table for additonal information
Responsible Party: Richard Eloin Liebano, Professor, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT04020861     History of Changes
Other Study ID Numbers: CAAE: 81711417.0.0000.5504
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available upon requested of principal investigator.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard Eloin Liebano, Universidade Federal de Sao Carlos:
Electrophysical agents
Low-level laser therapy
TENS
Neck pain
Chronic pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms