Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

Not Applicable

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT03463343
• Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2014-07-01
• Study Completion: 2016-10-01
• Study First Submitted: 2017-09-08
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-10
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pressure pain thresholds	Immediately after the intervention	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.
Pressure pain perception	Immediately after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Muscle tone	Immediately after the intervention	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.
Muscle stiffness	Immediately after the intervention	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.
Muscle elasticity	Immediately after the intervention	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.