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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02904668
Other study ID # DF0061UG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date December 2016

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 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.


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 Completed
Enrollment 53
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
self-managmeent 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Outcome

Type Measure Description Time frame Safety issue
Primary Disability 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 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 3 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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