Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients

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

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Device: Active PBM; Device: Active TENS; Device: Placebo TENS; Device: Placebo PBM

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Carlos, SP, Brazil, 13565-905
      • Federal University São Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	2 weeks after randomization
Cervical range of motion	Cervical range of motion will be measured with a fleximeter	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	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.	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.	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.	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.	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.	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.	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).	2 weeks and 6 weeks after randomization

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ACTUAL): June 25, 2021
• Study Completion (ACTUAL): July 25, 2021

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: TENS; Chronic pain; Neck pain; Low-level laser therapy; Electrophysical agents
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: CAAE: 81711417.0.0000.5504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon requested of principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No