Hypoalgesic Effect of Electrical Current and Cervical Manipulation

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Pain

Treatments: Device: Application of TENS; Device: Placebo TENS; Device: Placebo CJM; Device: CJM

Study type: Interventional

Funder types: Other

Identifiers

NCT03531541

U1111-1212-5389

Details and patient eligibility

About

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

Full 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

Enrollment: 144 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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144 participants in 4 patient groups, including a placebo group

active TENS and CJM

Active Comparator group

Description:

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).

Treatment:

Device: CJM

Device: Application of TENS

placebos TENS and CJM

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo CJM

Device: Placebo TENS

placebo TENS and active CJM

Active Comparator group

Description:

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.

Treatment:

Device: CJM

Device: Placebo TENS

active TENS and placebo CJM

Active Comparator group

Description:

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.

Treatment:

Device: Placebo CJM

Device: Application of TENS