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

NCT02982369 | Completed

• 2 other identifiers: MBrachtU1111-1190-4280
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

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

  4 weeks after randomization

Secondary Outcomes (7)

• Cytokines

  4 weeks after randomization

• Pressure Pain Threshold

  4 weeks and 3 months after randomization

• Disability

  4 weeks and 3 months after randomization

• Fear Avoidance Beliefs

  4 weeks and 3 months after randomization

• Health-related Quality of Life

  4 weeks and 3 months after randomization

Study Arms (2)

Spinal Manipulation

EXPERIMENTAL

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; Other: Pain Education

Pain Education

SHAM COMPARATOR

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; Other: Sham

Interventions

Spinal Manipulation OTHER

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

Also known as: Vertebral Manipulation

Spinal Manipulation

Pain Education OTHER

Subjects will receive pain education based in biopsychosocial approach

Also known as: Pain Neuroscience Education

Pain Education; Spinal Manipulation

Sham OTHER

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

Pain Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Catarina Federal University: lead

Study Sites (1)

Santa Catarina Federal University

Florianópolis, Santa Catarina, 88040-900, Brazil

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Adair R Soares dos Santos, PhD

  Santa Catarina Federal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 18, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

BR (1)