NCT02703506

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

February 25, 2016

Last Update Submit

December 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Measured by a Visual Analog Scale

    Change From Baseline in Pain Scores on the Visual Analog Scale at three months

Study Arms (2)

Experimental. Pain Education Program

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Five group sessions of patient education pain of 60-120 minutes one for week with a maximum of 10 participants.

Experimental. Pain Education Program

Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Perez-Munoz M, Rodriguez-Costa I, Lebrijo-Perez G, Pecos-Martin D, Gallego-Izquierdo T, Perez-Martin Y. Design of a Health Education Program to Manage Chronic Neck Pain: Protocol for a Development Study. JMIR Res Protoc. 2024 Oct 1;13:e56632. doi: 10.2196/56632.

MeSH Terms

Conditions

Neck Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Daniel PM Pecos-Martín, Dr

    Alcala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share