Hypoalgesic Effect of Electrical Current and Cervical Manipulation
NCT ID: NCT03531541
Last Updated: 2019-02-08
Study Results
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Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2018-05-10
2019-01-27
Brief Summary
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Detailed Description
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TENS also promotes analgesia by activating a descending pathway, which originates in the periaqueductal grey (PAG) and in the rostroventromedial medulla (RVM) to inhibit the excitability of nociceptive neurons in the dorsal horn of the spinal cord.
Joint manipulation generates a series of stimuli within the central nervous system through the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG, causing pain inhibition by activation of non-opioid descending inhibitory pathways
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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active TENS and CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust).
Application of TENS
The subject's skin will be cleaned with mild soap and water. Two square self-adhesive electrodes (5x5cm) will be placed 1 cm below the olecranon of the ulna and 10 cm above the radiocarpal joint of the dominant hand, maintaining the PPT measurement region between two electrodes. Two identical TENS units will be used: an active and a placebo (Neurodyn Portable TENS, IBRAMED). The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. Participants will be asked about the intensity of TENS every 5 minutes, and if the intensity has faded, the intensity will be increased again to a strong but comfortable level.
CJM
The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust). If the patient does not experience joint cavitation during the maneuver, two more attempts will be made. If no sound occurs on the third attempt, the joints will be considered manipulated.
placebos TENS and CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies\[42-44\]. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect
Placebo TENS
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Participants will be informed that TENS can cause a slight tingling sensation or any sensation during the procedure. They will be asked every 5 minutes if they are comfortable, without increasing intensity as in the active TENS group
Placebo CJM
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect. The maneuvers will be carried out by a physiotherapist with more than 5 years of experience in manual therapy. The active or placebo manipulation will be performed on the right or left side according to randomization.
placebo TENS and active CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
CJM
The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust). If the patient does not experience joint cavitation during the maneuver, two more attempts will be made. If no sound occurs on the third attempt, the joints will be considered manipulated.
Placebo TENS
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Participants will be informed that TENS can cause a slight tingling sensation or any sensation during the procedure. They will be asked every 5 minutes if they are comfortable, without increasing intensity as in the active TENS group
active TENS and placebo CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
Application of TENS
The subject's skin will be cleaned with mild soap and water. Two square self-adhesive electrodes (5x5cm) will be placed 1 cm below the olecranon of the ulna and 10 cm above the radiocarpal joint of the dominant hand, maintaining the PPT measurement region between two electrodes. Two identical TENS units will be used: an active and a placebo (Neurodyn Portable TENS, IBRAMED). The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. Participants will be asked about the intensity of TENS every 5 minutes, and if the intensity has faded, the intensity will be increased again to a strong but comfortable level.
Placebo CJM
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect. The maneuvers will be carried out by a physiotherapist with more than 5 years of experience in manual therapy. The active or placebo manipulation will be performed on the right or left side according to randomization.
Interventions
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Application of TENS
The subject's skin will be cleaned with mild soap and water. Two square self-adhesive electrodes (5x5cm) will be placed 1 cm below the olecranon of the ulna and 10 cm above the radiocarpal joint of the dominant hand, maintaining the PPT measurement region between two electrodes. Two identical TENS units will be used: an active and a placebo (Neurodyn Portable TENS, IBRAMED). The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. Participants will be asked about the intensity of TENS every 5 minutes, and if the intensity has faded, the intensity will be increased again to a strong but comfortable level.
CJM
The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust). If the patient does not experience joint cavitation during the maneuver, two more attempts will be made. If no sound occurs on the third attempt, the joints will be considered manipulated.
Placebo TENS
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Participants will be informed that TENS can cause a slight tingling sensation or any sensation during the procedure. They will be asked every 5 minutes if they are comfortable, without increasing intensity as in the active TENS group
Placebo CJM
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect. The maneuvers will be carried out by a physiotherapist with more than 5 years of experience in manual therapy. The active or placebo manipulation will be performed on the right or left side according to randomization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no pain complaints from the last 90 days
Exclusion Criteria
* spinal canal stenosis
* vertebral fracture
* spondylolisthesis
* cancer
* acute infections
* hemorrhagic disorders
* active tuberculosis
* deep vein thrombosis
* osteoporosis
* diseases rheumatic
* diseases metabolic
* cardiorespiratory diseases
* headache in the last seven days
* smoking
* changes in skin sensitivity
* use of pacemaker
* women in menstrual period
* pregnant women
* use of pain-killers in the last 48 hours
* use of anti-inflammatory drugs in the last 48 hours
* previous electrostimulation
* previous cervical joint manipulation treatments
* hypersensitivity to TENS application
* aversion to cervical joint manipulation
* positive test for vertebral artery.
18 Years
30 Years
ALL
Yes
Sponsors
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Universidade Federal de Sao Carlos
OTHER
Responsible Party
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Jonathan Daniel Telles
Principal Investigator
Principal Investigators
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Richard E Liebano, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de São Carlos - UFScar
Locations
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Centro Universitário Católico Salesiano Auxilium de Lins
Lins, São Paulo, Brazil
Ufscar - Universidade Federal de São Carlos
São Carlos, São Paulo, Brazil
Countries
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References
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Related Links
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The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine
Other Identifiers
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U1111-1212-5389
Identifier Type: -
Identifier Source: org_study_id
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