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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2018

Interventions

  • Other: Spinal Manipulation
    • High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region
  • Other: Pain Education
    • Subjects will receive pain education based in biopsychosocial approach
  • Other: Sham
    • A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Santa Catarina Federal University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marcelo Anderson Bracht, Principal Investigator – Santa Catarina Federal University
  • Overall Official(s)
    • Adair R Soares dos Santos, PhD, Study Director, Santa Catarina Federal University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.