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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03702075
Other study ID # DF0080UG
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date February 2019

Study information

Verified date October 2018
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date February 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Faculty of Health Sciences. University of Granada. Granada. Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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