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Completed

NCT Number: NCT03531541

Hypoalgesic Effect of Electrical Current and Cervical Manipulation

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

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Católico Salesiano Auxilium de Lins, Lins, São Paulo, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application of TENS

Device

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 names: Transcutaneous Electrical Nerve Stimulation (TENS)

CJM

Device

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 names: Cervical Joint Manipulation

Placebo TENS

Device

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 names: Placebo Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo CJM

Device

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 names: Placebo Cervical Joint Manipulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation and Cervical Joint Manipulation on Pressure Pain Threshold

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 21, 2018
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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