Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
NCT04020861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2021-09-05
Summary
This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.
Conditions
- Chronic Neck Pain
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Fundação de Amparo à Pesquisa do Estado de São Paulo
collaborator OTHER_GOV -
Universidade Federal de Sao Carlos
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-06
- Primary Completion
- 2021-06-25
- Completion
- 2021-07-25
Countries
- Brazil
Study Locations
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