search
Back to results

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

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active PBM
Active TENS
Placebo PBM
Placebo TENS
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Electrophysical agents, Low-level laser therapy, TENS, Neck pain, Chronic pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University São Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

PBM + TENS

PBM

TENS

Placebo

Arm Description

The patients will be submitted to the active PBM and active TENS

The patients will be submitted to the active PBMT and placebo TENS

The patients will be submitted to the placebo PBMT and active TENS

The patients will be submitted to the placebo PBMT and placebo TENS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.
Cervical range of motion
Cervical range of motion will be measured with a fleximeter
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
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
July 5, 2019
Last Updated
September 3, 2021
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT04020861
Brief Title
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Official Title
Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Electrophysical agents, Low-level laser therapy, TENS, Neck pain, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBM + TENS
Arm Type
Active Comparator
Arm Description
The patients will be submitted to the active PBM and active TENS
Arm Title
PBM
Arm Type
Active Comparator
Arm Description
The patients will be submitted to the active PBMT and placebo TENS
Arm Title
TENS
Arm Type
Active Comparator
Arm Description
The patients will be submitted to the placebo PBMT and active TENS
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients will be submitted to the placebo PBMT and placebo TENS.
Intervention Type
Device
Intervention Name(s)
Active PBM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo PBM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo TENS
Intervention Description
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 Measure Information:
Title
Pain intensity: Numerical Rating Scale (Pain NRS)
Description
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.
Time Frame
2 weeks after randomization
Secondary Outcome Measure Information:
Title
Pain intensity: Numerical Rating Scale (Pain NRS)
Description
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.
Time Frame
6 weeks after randomization
Title
Pain intensity at movement: Numerical Rating Scale (Pain NRS)
Description
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)
Time Frame
2 weeks after randomization
Title
Neck disability
Description
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.
Time Frame
2 weeks after randomization
Title
Cervical range of motion
Description
Cervical range of motion will be measured with a fleximeter
Time Frame
2 weeks after randomization
Title
Pressure Pain Threshold
Description
Pressure pain threshold (PPT) in the neck, shoulder girdle and anterior tibialis muscle will be measured using a Somedic Type II pressure algometer
Time Frame
2 weeks after randomization
Title
Pain temporal summation (TS)
Description
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.
Time Frame
2 weeks after randomization
Title
Conditioned pain modulation (CPM)
Description
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.
Time Frame
2 weeks after randomization
Title
Depressive symptoms
Description
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.
Time Frame
2 weeks after randomization
Title
Pain catastrophizing
Description
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.
Time Frame
2 weeks after randomization
Title
Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)
Description
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.
Time Frame
2 weeks after randomization
Title
Analgesic intake
Description
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.
Time Frame
2 weeks after randomization
Title
Global perceived effect (GPE)
Description
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).
Time Frame
2 weeks and 6 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Federal University São Carlos
City
São Carlos
State/Province
SP
ZIP/Postal Code
13565-905
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon requested of principal investigator.
Citations:
PubMed Identifier
32080103
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs