Effectiveness of a Pain Education Program on Chronic Neck Pain Patients

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

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Session of Pain Education programe; Other: Control Group

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)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental. Pain Education Program; 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.	Other: Session of Pain Education programe; Five group sessions of patient education pain of 60-120 minutes one for week with a maximum of 10 participants.
Active Comparator: Control; 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 .	Other: Control Group; Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Measured by a Visual Analog Scale	Change From Baseline in Pain Scores on the Visual Analog Scale at three months

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Director: Daniel PM Pecos-Martín, Dr, Alcala University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimated): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: OE22/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO