Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

Healthy Subjects Clinical Trial

Official title:

Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463343
• Other study ID #: 20122017
• Status: Completed
• Phase: N/A
• First received: September 8, 2017
• Last updated: March 12, 2018
• Start date: May 1, 2013
• Est. completion date: October 1, 2016

Study information

• Verified date: March 2018
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.

Description:

In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 1, 2016
• Est. primary completion date: July 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects.

• Minimum of 18 years old.

Exclusion Criteria:

• Pain in cervical region, shoulders or arms.

• History of trauma or disease in the cervical region or upper limb.

• Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Cervical spine manual manipulation
In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered.
• Cervical spine mechanical manipulation
In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
• Placebo intervention
The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain thresholds	To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface. The values were expressed in Kg/cm2. The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.	Immediately after the intervention
Primary	Pressure pain perception	To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS). The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.	Immediately after the intervention
Secondary	Muscle tone	To measure muscle tone it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The non-neural tone was recorded as frequency.	Immediately after the intervention
Secondary	Muscle stiffness	To measure muscle stiffness it was used the MyotonPro device. It was used to evaluate this parameter both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The muscle stiffness was recorded as N/m.	Immediately after the intervention
Secondary	Muscle elasticity	To measure muscle elasticity it was used the MyotonPro device. It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally. The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them. The elasticity was indicated by logarithmic decrement.	Immediately after the intervention