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

NCT ID: NCT04020861

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2021-07-25

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.

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PBM + TENS

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

Group Type: ACTIVE_COMPARATOR

Active PBM

Intervention Type: DEVICE

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 TENS

Intervention Type: DEVICE

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.

PBM

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

Group Type: ACTIVE_COMPARATOR

Active PBM

Intervention Type: DEVICE

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.

Placebo TENS

Intervention Type: DEVICE

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.

TENS

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

Group Type: ACTIVE_COMPARATOR

Active TENS

Intervention Type: DEVICE

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 PBM

Intervention Type: DEVICE

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

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

Group Type: PLACEBO_COMPARATOR

Placebo PBM

Intervention Type: DEVICE

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 TENS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Richard Eloin Liebano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32080103 (View on PubMed)

Other Identifiers

CAAE: 81711417.0.0000.5504

Identifier Type: -

Identifier Source: org_study_id