Hypoalgesic Effect of Electrical Current and Cervical Manipulation

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531541
• Other study ID #: U1111-1212-5389
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: January 27, 2019

Study information

• Verified date: February 2019
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 27, 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Centro Universitário Católico Salesiano Auxilium de Lins	Lins	São Paulo
Brazil	Ufscar - Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold of the posterior region of the forearm	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.	1 minute after the end of the intervention.
Secondary	Pressure Pain Threshold of the posterior region of the forearm	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.	20 minutes after the end of the intervention
Secondary	Pressure Pain Threshold of the tibialis anterior muscle	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.	1 minute after the end of the intervention.
Secondary	Pressure Pain Threshold of the tibialis anterior muscle	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.	20 minutes after the end of the intervention

External Links

•   The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine