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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Spinal Manipulation
Pain Education
Sham
Sponsored by
Santa Catarina Federal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Santa Catarina Federal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal Manipulation

Pain Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2016
Last Updated
August 25, 2018
Sponsor
Santa Catarina Federal University
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1. Study Identification

Unique Protocol Identification Number
NCT02982369
Brief Title
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Official Title
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Catarina Federal University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Pain Education
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Other Intervention Name(s)
Vertebral Manipulation
Intervention Description
High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region
Intervention Type
Other
Intervention Name(s)
Pain Education
Other Intervention Name(s)
Pain Neuroscience Education
Intervention Description
Subjects will receive pain education based in biopsychosocial approach
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Time Frame
4 weeks after randomization
Secondary Outcome Measure Information:
Title
Cytokines
Description
Level of concentration of pro and anti-inflammatory cytokines
Time Frame
4 weeks after randomization
Title
Pressure Pain Threshold
Description
Pressure pain Threshold will be measured with a digital algometer
Time Frame
4 weeks and 3 months after randomization
Title
Disability
Description
Disability will be measured by the Neck Disability Index (NDI)
Time Frame
4 weeks and 3 months after randomization
Title
Fear Avoidance Beliefs
Description
Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)
Time Frame
4 weeks and 3 months after randomization
Title
Health-related Quality of Life
Description
Quality of Life will be measured by the 12-Item Health Survey (SF-12)
Time Frame
4 weeks and 3 months after randomization
Title
Kinesiophobia
Description
Kinesiophobia will be measured byTampa Scale for Kinesiophobia
Time Frame
4 weeks and 3 months after randomization
Title
Pain Intensity
Description
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Time Frame
3 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adair R Soares dos Santos, PhD
Organizational Affiliation
Santa Catarina Federal University
Official's Role
Study Director
Facility Information:
Facility Name
Santa Catarina Federal University
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88040-900
Country
Brazil

12. IPD Sharing Statement

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

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