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Effectiveness of a Pain Education Program on Chronic Neck Pain Patients

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Session of Pain Education programe
Control Group
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects over 18 years old
  • Subjects diagnosed with chronic neck pain.

Exclusion Criteria:

  • Patients with acute and subacute neck pain. Those presenting inflammatory, neurologic, rheumatic or heart disease or pacemakers. Patients with severe osteoporosis, fractures, dislocations, vertebrobasilar insufficiency, infection, metastatic tumor, pre and post-surgical etiology recent (less than one year after the intervention).

Psychopathology patients diagnosed by their doctor. Subjects who do not understand or speak the Spanish language.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental. Pain Education Program

    Control

    Arm Description

    Ten group sessions of treatment with a patient education pain for chronic neck pain (biopsychosocial approach). The group sessions of 60-120 minutes twice a week with a maximum of 10 participants.

    The control group: individualized session of physical therapy (TENS and exercise). Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises .

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale
    Measured by a Visual Analog Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    October 3, 2017
    Sponsor
    University of Alcala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02703506
    Brief Title
    Effectiveness of a Pain Education Program on Chronic Neck Pain Patients
    Official Title
    Effectiveness of a Pain Education Program on Chronic Neck Pain Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alcala

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This project aims to study the effectiveness of a pain education program in the improvement of chronic pain and disability/impairment. Assuming the definition established in the United States in 1975 on the fourth working group of the National Conference on Preventive Medicine: "Health education must be a process that informs, motivates and helps people to adopt and maintain practices and healthy lifestyles, environmental advocates changes necessary to facilitate these objectives and professional training and directs research towards the same objectives. " Once the need of educating patients is stablished on subjects with diseases, it is necessary to encourage them to actively participate on the control of them and to achieve significant improvement of adherence
    Detailed Description
    BACKGROUND AND PURPOSE: Patient education over the knowledge of pain causes and perpetuating psicosocial factos, so as a gradual physical therapy intervention may success in modifying habits, and consequently emotional state and behaviour in order to maintain or recover subject's social participation being this program effective in pain diminution over chronic neck pain. Main goal: To evaluate the effectiveness of a pain education program for patients with chronic neck pain, to decrease the intensity of pain in front of one physiotherapy program (TENS and exercise) Experimental group: Will receive five group sessions of 60-120 minutes twice a week with a maximum of 10 participants. Control group: Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises. OUTCOMES Primary outcome Intensity of pain, measured by the visual analog scale: VAS. The mean of the values wil be calculated described in the assessment, the mean of the last week was also compiled. The degree of neck disability/impairment measured using the Northwick Park Pain Questionnaire (NPPQ)

    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental. Pain Education Program
    Arm Type
    Experimental
    Arm Description
    Ten group sessions of treatment with a patient education pain for chronic neck pain (biopsychosocial approach). The group sessions of 60-120 minutes twice a week with a maximum of 10 participants.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The control group: individualized session of physical therapy (TENS and exercise). Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises .
    Intervention Type
    Other
    Intervention Name(s)
    Session of Pain Education programe
    Intervention Description
    Five group sessions of patient education pain of 60-120 minutes one for week with a maximum of 10 participants.
    Intervention Type
    Other
    Intervention Name(s)
    Control Group
    Intervention Description
    Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    Measured by a Visual Analog Scale
    Time Frame
    Change From Baseline in Pain Scores on the Visual Analog Scale at three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects over 18 years old Subjects diagnosed with chronic neck pain. Exclusion Criteria: Patients with acute and subacute neck pain. Those presenting inflammatory, neurologic, rheumatic or heart disease or pacemakers. Patients with severe osteoporosis, fractures, dislocations, vertebrobasilar insufficiency, infection, metastatic tumor, pre and post-surgical etiology recent (less than one year after the intervention). Psychopathology patients diagnosed by their doctor. Subjects who do not understand or speak the Spanish language.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel PM Pecos-Martín, Dr
    Organizational Affiliation
    Alcala University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of a Pain Education Program on Chronic Neck Pain Patients

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