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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982369
• Other study ID #: MBracht
• Secondary ID: U1111-1190-4280
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: April 18, 2018

Study information

• Verified date: August 2018
• Source: Santa Catarina Federal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 18, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Santa Catarina Federal University	Florianopolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Santa Catarina Federal University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Intensity of pain will be measured by the numeric pain rating scale (NPRS)	4 weeks after randomization
Secondary	Cytokines	Level of concentration of pro and anti-inflammatory cytokines	4 weeks after randomization
Secondary	Pressure Pain Threshold	Pressure pain Threshold will be measured with a digital algometer	4 weeks and 3 months after randomization
Secondary	Disability	Disability will be measured by the Neck Disability Index (NDI)	4 weeks and 3 months after randomization
Secondary	Fear Avoidance Beliefs	Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)	4 weeks and 3 months after randomization
Secondary	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
Secondary	Kinesiophobia	Kinesiophobia will be measured byTampa Scale for Kinesiophobia	4 weeks and 3 months after randomization
Secondary	Pain Intensity	Intensity of pain will be measured by the numeric pain rating scale (NPRS)	3 months after randomization