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Completed

NCT Number: NCT02816060

Neural Tensioner Exercise on Conditioned Pain Modulation

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.

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Key information

Conditions

Neck Pain Diffuse Noxious Inhibitory Control Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Therapy

Procedure

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

Primary outcomes

  1. Physiological parameter

    Time frame: 5 minutes

    Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test

Secondary outcomes

  1. Visual analogue scale

    Time frame: 5 minutes

    Neck pain intensity measured by visual analogue scale (VAS)

  2. physiological movement

    Time frame: 5 minutes

    Cervical range of motion measured with cervical range of motion device

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Effectiveness of Neural Tensioner Exercise on Conditioned Pain Modulation, Disability and Range of Motion in Patients With Chronic Neck Pain: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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