The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain

This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Spinal Manipulation; Other: Pain Education; Other: Sham

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil, 88040-900
      • Santa Catarina Federal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Main complaint of Neck Pain for at least six (6) months;
• Score of at least 10 points in NDI (Neck Disability Index);
• Pain and / or restriction of cervical movements;
• Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
• The definition of the term Neck Pain follows the classification of TFNP.

Exclusion Criteria:

• Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
• History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
• Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
• Red flags contraindicating spinal manipulation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Manipulation; High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.	Other: Spinal Manipulation; High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region; Other Names: Vertebral Manipulation; Other: Pain Education; Subjects will receive pain education based in biopsychosocial approach; Other Names: Pain Neuroscience Education
Sham Comparator: Pain Education; Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.	Other: Pain Education; Subjects will receive pain education based in biopsychosocial approach; Other Names: Pain Neuroscience Education; Other: Sham; A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Intensity of pain will be measured by the numeric pain rating scale (NPRS)	4 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines	Level of concentration of pro and anti-inflammatory cytokines	4 weeks after randomization
Pressure Pain Threshold	Pressure pain Threshold will be measured with a digital algometer	4 weeks and 3 months after randomization
Disability	Disability will be measured by the Neck Disability Index (NDI)	4 weeks and 3 months after randomization
Fear Avoidance Beliefs	Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)	4 weeks and 3 months after randomization
Health-related Quality of Life	Quality of Life will be measured by the 12-Item Health Survey (SF-12)	4 weeks and 3 months after randomization
Kinesiophobia	Kinesiophobia will be measured byTampa Scale for Kinesiophobia	4 weeks and 3 months after randomization
Pain Intensity	Intensity of pain will be measured by the numeric pain rating scale (NPRS)	3 months after randomization

Collaborators and Investigators

• Sponsor: Santa Catarina Federal University
• Investigators: Study Director: Adair R Soares dos Santos, PhD, Santa Catarina Federal University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 25, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: MBracht; U1111-1190-4280 (Other Identifier: World Health Organization (WHO))