Hypoalgesic Effect of Electrical Current and Cervical Manipulation

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT03531541
• Lead Sponsor: 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

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

Study Timeline

• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-08
• Study Start: 2018-05-10
• Study First Posted: 2018-05-21
• Primary Completion: 2018-11-20
• Study Completion: 2019-01-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Pressure Pain Threshold of the posterior region of the forearm	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

Name	Time	Method
Pressure Pain Threshold of the tibialis anterior muscle	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.
Pressure Pain Threshold of the posterior region of the forearm	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.

Trial Locations

Locations (2)

Centro Universitário Católico Salesiano Auxilium de Lins; 🇧🇷 Lins, São Paulo, Brazil

Ufscar - Universidade Federal de São Carlos; 🇧🇷 São Carlos, São Paulo, Brazil