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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02982369
Enrollment
90
Registered
2016-12-05
Start date
2016-12-01
Completion date
2018-04-18
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Brief 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.

Interventions

OTHERSpinal Manipulation

High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region

OTHERPain Education

Subjects will receive pain education based in biopsychosocial approach

OTHERSham

A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.

Sponsors

Santa Catarina Federal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity4 weeks after randomizationIntensity of pain will be measured by the numeric pain rating scale (NPRS)

Secondary

MeasureTime frameDescription
Pressure Pain Threshold4 weeks and 3 months after randomizationPressure pain Threshold will be measured with a digital algometer
Disability4 weeks and 3 months after randomizationDisability will be measured by the Neck Disability Index (NDI)
Fear Avoidance Beliefs4 weeks and 3 months after randomizationFear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)
Cytokines4 weeks after randomizationLevel of concentration of pro and anti-inflammatory cytokines
Kinesiophobia4 weeks and 3 months after randomizationKinesiophobia will be measured byTampa Scale for Kinesiophobia
Pain Intensity3 months after randomizationIntensity of pain will be measured by the numeric pain rating scale (NPRS)
Health-related Quality of Life4 weeks and 3 months after randomizationQuality of Life will be measured by the 12-Item Health Survey (SF-12)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026