search
Back to results

Self-management Program in Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
self-managmeent program
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring chronic pain

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic neck pain (at least 6 months' duration) not related to trauma .

Exclusion Criteria:

  • Whiplash related neck pain
  • Previous cervical surgical intervention
  • Cognitive impairments which prevent them to follow instructions
  • Visual or acoustic limitations
  • Physical therapy in the previous six months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Patients allocated to the experimental group were included in a self-management program and manual therapy program

    The intervention consisted of 45-minute manual therapy sessions. Manual therapy included "hands-on" muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature)

    Outcomes

    Primary Outcome Measures

    Disability
    Disability will be explored using the Neck Disability Index. The patients rated their current pain and average pain over the past week on a 0-10 numerical rating scale

    Secondary Outcome Measures

    Pain severity
    Pain will be assessed using the Brief Pain Inventory. It measures the degree of interference of pain with various aspects of life, including mobility and social activities (reactive pain) and pain severity (sensory pain).
    Health related quality of life
    Health related quality of life will be measured by euroQol-5D. It contains two sections, a descriptive section and a valuation section.
    Fear avoidance beliefs
    Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).
    Anxiety and depression
    Anxiety and depression was evaluated by the the Hospital Anxiety and Depression Scale (HAD).It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items)

    Full Information

    First Posted
    September 2, 2016
    Last Updated
    October 8, 2018
    Sponsor
    Universidad de Granada
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02904668
    Brief Title
    Self-management Program in Chronic Neck Pain
    Official Title
    Effects of a Self-management Program in Patients With Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Granada

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.
    Detailed Description
    Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. No previous study has used foam roller in patients with neck pain. In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction. It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Patients allocated to the experimental group were included in a self-management program and manual therapy program
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The intervention consisted of 45-minute manual therapy sessions. Manual therapy included "hands-on" muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature)
    Intervention Type
    Other
    Intervention Name(s)
    self-managmeent program
    Intervention Description
    One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
    Primary Outcome Measure Information:
    Title
    Disability
    Description
    Disability will be explored using the Neck Disability Index. The patients rated their current pain and average pain over the past week on a 0-10 numerical rating scale
    Time Frame
    Change from baseline pain at 3 weeks
    Secondary Outcome Measure Information:
    Title
    Pain severity
    Description
    Pain will be assessed using the Brief Pain Inventory. It measures the degree of interference of pain with various aspects of life, including mobility and social activities (reactive pain) and pain severity (sensory pain).
    Time Frame
    Change from baseline pain at 3 weeks
    Title
    Health related quality of life
    Description
    Health related quality of life will be measured by euroQol-5D. It contains two sections, a descriptive section and a valuation section.
    Time Frame
    Change from baseline health related quality of life at 4 weeks
    Title
    Fear avoidance beliefs
    Description
    Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).
    Time Frame
    Change from baseline fear avoidance beliefs at 4 weeks
    Title
    Anxiety and depression
    Description
    Anxiety and depression was evaluated by the the Hospital Anxiety and Depression Scale (HAD).It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items)
    Time Frame
    Change from baseline anxiety and depression at 4 weeks

    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: Chronic neck pain (at least 6 months' duration) not related to trauma . Exclusion Criteria: Whiplash related neck pain Previous cervical surgical intervention Cognitive impairments which prevent them to follow instructions Visual or acoustic limitations Physical therapy in the previous six months

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Self-management Program in Chronic Neck Pain

    We'll reach out to this number within 24 hrs