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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02816060
Other study ID # 14/2013
Secondary ID
Status Completed
Phase N/A
First received June 9, 2016
Last updated March 8, 2017
Start date May 2016
Est. completion date November 2016

Study information

Verified date March 2017
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.

Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.

Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.

Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- aged 18-65 years.

- neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.

- the ability to understand, write, and speak Spanish fluently

Exclusion Criteria:

- development of systemic or degenerative diseases;

- symptoms of depression according to Beck's questionnaire.

- pain in any area between the lower back and the head in the last 9 months.

- neck pain associated with whiplash injuries.

- medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.

- neck pain associated with externalized cervical disc herniation.

- fibromyalgia syndrome.

- previous neck surgery.

- neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months.

- and history of neck or face pain in the last 6 months.

Study Design


Related Conditions & MeSH terms

  • Diffuse Noxious Inhibitory Control
  • Neck Pain

Intervention

Procedure:
manual therapy
manual therapy with neural exercise will be applied on patients with neck pain

Locations

Country Name City State
Spain Universidad Rey Juan Carlos Alcorcon Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiological parameter Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test 5 minutes
Secondary Visual analogue scale Neck pain intensity measured by visual analogue scale (VAS) 5 minutes
Secondary physiological movement Cervical range of motion measured with cervical range of motion device 5 minutes
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