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Hypoalgesic Effect of Electrical Current and Cervical Manipulation

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ClinicalTrials.gov Identifier: NCT03531541
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Daniel Telles, Universidade Federal de Sao Carlos

Brief Summary:
This study evaluates the hypoalgesic effect of the TENS application associated with joint manipulation of the cervical region in healthy individuals. One group had both active treatments, the other group received both placebo treatments, the third and fourth group received only one of the two treatments actively and the other placebo

Condition or disease Intervention/treatment Phase
Pain Device: Application of TENS Device: CJM Device: Placebo TENS Device: Placebo CJM Not Applicable

Detailed Description:

Transcutaneous Electrical Nerve Stimulation (TENS) and Cervical Joint Manipulation (CJM) are often used for pain treatment.

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The participants will be randomly allocated into 4 groups: (G1) active TENS and CJM, (G2) placebo TENS and CJM, (G3) placebo TENS and active CJM, (G4) active TENS and placebo CJM.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The blinding will be assessed by examiner 2 (responsible for administering TENS) asking the participants which TENS intervention they think they received, with 3 options for the answer: "active," "placebo" or "don't know". The same questions will be asked by examiner 2 for CJM. Next, examiner 3 (responsible for administering CJM) will receive the blinding outcome and have 3 options for the answer: "active," "placebo" or "don't know". Examiner 1 will receive the blinding outcome will be asked: "Which group does the patient belong to: active TENS and CJM, active TENS and placebo CJM, placebo TENS and active CJM or placebo TENS and CJM" Their responses to these questions will be recorded and used to measure the adequacy of participants and examiners
Primary Purpose: Basic Science
Official Title: Transcutaneous Electrical Nerve Stimulation and Cervical Joint Manipulation on Pressure Pain Threshold
Actual Study Start Date : May 10, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : January 27, 2019

Arm Intervention/treatment
Active Comparator: 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).

Device: 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.
Other Name: Transcutaneous Electrical Nerve Stimulation (TENS)

Device: 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.
Other Name: Cervical Joint Manipulation

Placebo Comparator: 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

Device: 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
Other Name: Placebo Transcutaneous Electrical Nerve Stimulation (TENS)

Device: 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 Name: Placebo Cervical Joint Manipulation

Active Comparator: 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.

Device: 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.
Other Name: Cervical Joint Manipulation

Device: 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
Other Name: Placebo Transcutaneous Electrical Nerve Stimulation (TENS)

Active Comparator: 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.

Device: 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.
Other Name: Transcutaneous Electrical Nerve Stimulation (TENS)

Device: 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 Name: Placebo Cervical Joint Manipulation




Primary Outcome Measures :
  1. Pressure Pain Threshold of the posterior region of the forearm [ Time Frame: 1 minute after the end of the intervention. ]
    The examiner will use a Somedic Type II digital pressure algometer (Somedic Inc, Hörby, Sweden) on the posterior region of the forearm 10cm below the lateral epicondyle of the elbow towards the third finger, with the forearm maintained in pronation. Next, the pressure will be applied perpendicularly to the skin at a rate of 40kPa/s using a flat, 1cm2 circular probe covered with 1mm of rubber to avoid any skin pain from sharp metal edges. The average of the PPT scores (in kPa) will be recorded by the assessor.


Secondary Outcome Measures :
  1. Pressure Pain Threshold of the posterior region of the forearm [ Time Frame: 20 minutes after the end of the intervention ]
    The examiner will use a Somedic Type II digital pressure algometer (Somedic Inc, Hörby, Sweden) on the posterior region of the forearm 10cm below the lateral epicondyle of the elbow towards the third finger, with the forearm maintained in pronation. Next, the pressure will be applied perpendicularly to the skin at a rate of 40kPa/s using a flat, 1cm2 circular probe covered with 1mm of rubber to avoid any skin pain from sharp metal edges. The average of the PPT scores (in kPa) will be recorded by the assessor.

  2. Pressure Pain Threshold of the tibialis anterior muscle [ Time Frame: 1 minute after the end of the intervention. ]
    For the PPT assessment over the tibialis anterior muscle of the dominant side, the patient will be positioned supine on a stretcher with the knees flexed at 90°. The examiner will place the pressure algometer 5 cm below the tibial tuberosity and 2.5 cm laterally to the tibial tuberosity over the tibialis anterior muscle.

  3. Pressure Pain Threshold of the tibialis anterior muscle [ Time Frame: 20 minutes after the end of the intervention ]
    For the PPT assessment over the tibialis anterior muscle of the dominant side, the patient will be positioned supine on a stretcher with the knees flexed at 90°. The examiner will place the pressure algometer 5 cm below the tibial tuberosity and 2.5 cm laterally to the tibial tuberosity over the tibialis anterior muscle.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects
  • no pain complaints from the last 90 days

Exclusion Criteria:

  • previous spinal surgeries
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531541


Locations
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Brazil
Centro Universitário Católico Salesiano Auxilium de Lins
Lins, São Paulo, Brazil, 16400-505
Ufscar - Universidade Federal de São Carlos
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Richard E Liebano, Dr. Universidade Federal de São Carlos - UFScar

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Daniel Telles, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03531541     History of Changes
Other Study ID Numbers: U1111-1212-5389
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Daniel Telles, Universidade Federal de Sao Carlos:
TENS
cervical manipulation
pressure pain