Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

NCT03463343 | Completed

• 1 other identifier: 20122017
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Muscle tone

  Immediately after the intervention

• Muscle stiffness

  Immediately after the intervention

• Muscle elasticity

  Immediately after the intervention

Study Arms (4)

Manual manipulation

EXPERIMENTAL

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

Mechanical manipulation

ACTIVE COMPARATOR

In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.

Other: Cervical spine mechanical manipulation

Placebo

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

The subjects stayed in supine position and no intervention occurred.

Interventions

Cervical spine manual manipulation OTHER

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.

Manual manipulation

Cervical spine mechanical manipulation OTHER

In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.

Mechanical manipulation

Placebo intervention OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects.
• Minimum of 18 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Officials

• Nuno Nogueira, MSc

  Instituto Politécnico da Saúde do Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Invited Professor

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: March 13, 2018
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share