Self-management Program in Chronic Neck Pain

October 8, 2018 updated by: Marie Carmen Valenza, Universidad de Granada

Effects of a Self-management Program in Patients With Chronic Neck Pain

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. No previous study has used foam roller in patients with neck pain. In addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction. It was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic neck pain (at least 6 months' duration) not related to trauma .

Exclusion Criteria:

  • Whiplash related neck pain
  • Previous cervical surgical intervention
  • Cognitive impairments which prevent them to follow instructions
  • Visual or acoustic limitations
  • Physical therapy in the previous six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients allocated to the experimental group were included in a self-management program and manual therapy program
One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
Active Comparator: Control group
The intervention consisted of 45-minute manual therapy sessions. Manual therapy included "hands-on" muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature)
One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Change from baseline pain at 3 weeks
Disability will be explored using the Neck Disability Index. The patients rated their current pain and average pain over the past week on a 0-10 numerical rating scale
Change from baseline pain at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: Change from baseline pain at 3 weeks
Pain will be assessed using the Brief Pain Inventory. It measures the degree of interference of pain with various aspects of life, including mobility and social activities (reactive pain) and pain severity (sensory pain).
Change from baseline pain at 3 weeks
Health related quality of life
Time Frame: Change from baseline health related quality of life at 4 weeks
Health related quality of life will be measured by euroQol-5D. It contains two sections, a descriptive section and a valuation section.
Change from baseline health related quality of life at 4 weeks
Fear avoidance beliefs
Time Frame: Change from baseline fear avoidance beliefs at 4 weeks
Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items).
Change from baseline fear avoidance beliefs at 4 weeks
Anxiety and depression
Time Frame: Change from baseline anxiety and depression at 4 weeks
Anxiety and depression was evaluated by the the Hospital Anxiety and Depression Scale (HAD).It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items)
Change from baseline anxiety and depression at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0061UG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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