MedDataX Logo

Effectiveness of a Pain Education Program on Chronic Neck Pain Patients

NCT ID: NCT02703506

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Session of Pain Education programe

Intervention Type OTHER

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

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 .

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Control Group

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alcala

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Daniel Pecos Martín

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel PM Pecos-Martín, Dr

Role: STUDY_DIRECTOR

Alcala University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39353191 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OE22/2015

Identifier Type: -

Identifier Source: org_study_id