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Completed

NCT Number: NCT02982369

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Catarina Federal University

Florianópolis, Santa Catarina, 88040-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal Manipulation

Other

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

Other names: Vertebral Manipulation

Pain Education

Other

Subjects will receive pain education based in biopsychosocial approach

Other names: Pain Neuroscience Education

SHAM

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 4 weeks after randomization

    Intensity of pain will be measured by the numeric pain rating scale (NPRS)

Secondary outcomes

  1. Cytokines

    Time frame: 4 weeks after randomization

    Level of concentration of pro and anti-inflammatory cytokines

  2. Pressure Pain Threshold

    Time frame: 4 weeks and 3 months after randomization

    Pressure pain Threshold will be measured with a digital algometer

  3. Disability

    Time frame: 4 weeks and 3 months after randomization

    Disability will be measured by the Neck Disability Index (NDI)

  4. Fear Avoidance Beliefs

    Time frame: 4 weeks and 3 months after randomization

    Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)

  5. 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)

  6. Kinesiophobia

    Time frame: 4 weeks and 3 months after randomization

    Kinesiophobia will be measured byTampa Scale for Kinesiophobia

  7. Pain Intensity

    Time frame: 3 months after randomization

    Intensity of pain will be measured by the numeric pain rating scale (NPRS)

Sponsors and collaborators

Lead sponsor

Santa Catarina Federal University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2016
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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