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
About this trial
This is an interventional treatment trial for Neck Pain
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.
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
NCT ID
NCT02703506
First Posted
February 25, 2016
Last Updated
October 3, 2017
Sponsor
University of Alcala
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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