Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Cervical spine manual manipulation; Other: Cervical spine mechanical manipulation; Other: Placebo intervention

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Mechanical manipulation; In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.	Other: Cervical spine mechanical manipulation; In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
Placebo Comparator: Placebo; 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.	Other: 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.
No Intervention: Control; The subjects stayed in supine position and no intervention occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde do Porto
• Investigators: Principal Investigator: Nuno Nogueira, MSc, Instituto Politécnico da Saúde do Norte

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20122017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No