search
Back to results

Self-administered Program in Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
self-administered program
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring chronic neck pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Health Sciences. University of Granada.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Trigger points examination
Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles

Secondary Outcome Measures

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).
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.
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.
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.
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).
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)

Full Information

First Posted
October 8, 2018
Last Updated
October 10, 2018
Sponsor
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT03702075
Brief Title
Self-administered Program in Chronic Neck Pain
Official Title
Effects of a Self-administered Program in Chronic Neck Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
chronic neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
self-administered program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trigger points examination
Description
Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles
Time Frame
Change from baseline trigger points examination at 4 weeks
Secondary Outcome Measure Information:
Title
Pain severity
Description
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).
Time Frame
Change from baseline pain at 4 weeks
Title
Functionality
Description
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.
Time Frame
Change from baseline functionality at 4 weeks
Title
Cervical range of motion
Description
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.
Time Frame
Change from baseline cervical range of motion at 4 weeks
Title
Health related quality of life
Description
Health related quality of life will be measured by euroQol-5D. It contains two sections, a descriptive section and a valuation section.
Time Frame
Change from baseline health related quality of life at 4 weeks
Title
Fear avoidance beliefs
Description
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).
Time Frame
Change from baseline fear avoidance beliefs at 4 weeks
Title
Anxiety and depression
Description
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)
Time Frame
Change from baseline anxiety and depression at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada.
State/Province
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Self-administered Program in Chronic Neck Pain

We'll reach out to this number within 24 hrs