Self-administered Program in Chronic Neck Pain

Effects of a Self-administered Program in Chronic Neck Pain Patients

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 are 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: Unknown
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: self-administered program

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 (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada
    • Granada., Granada, Spain, 18071
      • Faculty of Health Sciences. University of Granada.

Participation Criteria

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 3 months' duration) not related to trauma of at least 3 on a visual analogue scale
• Participants' symptoms had to be reproduced by median nerve upper-limb neurodynamic test.

Exclusion Criteria:

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients allocated to the experimental group were included in a self-administered program combining self-myofascial release using foam rollers and roller balls and active upper limb neurodynamic exercises. It consisted of three sessions of 50-60 minutes per week for 4 consecutive weeks.	Other: self-administered program; One session was a session supervised by a physical therapist in the Faculty of Health Sciences. This session took place in groups of three or four people. All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session.
No Intervention: Control group; Those patients allocated to the control group received a booklet with information regarding neck pain and explaining basic exercises for active mobilization and stretching with pictures and a short text.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trigger points examination	Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles	Change from baseline trigger points examination at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	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	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	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
Pain severity	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 4 weeks
Functionality	Functionality will be assessed by the Neck Outcome Score. This is a reliable, valid and responsive measure of self-reported disability for patients with neck pain. It includes 34 items divided into 5 subscales: Mobility, symptoms, sleep disturbance, every day activity and pain and participation in everyday life.	Change from baseline functionality at 4 weeks
Cervical range of motion	Cervical range of motion will be measured using a cervical goniometer. Subjects perform neck movements to the fullest extent of their mobility of flexion, extension, right and left lateroflexion, and right and left rotation.	Change from baseline cervical range of motion at 4 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: chronic neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: DF0080UG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No