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Completed

NCT Number: NCT02225873

The Effectiveness of Exercises Protocol in Management of Neck Pain

This study will verify whether the cranio-cervical flexion coordination (motor control) and muscle strength training protocol is more effective in improving muscle than the proprioception and muscle strength protocol in patients with chronic neck pain.

Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol will improve muscle function more than the proprioception and muscle strength protocol in patients with chronic cervical pain.

Objective: To find out if applying the strength therapeutic exercise protocol and the craniocervical flexion coordination (motor control) training is more effective than the strength and articular repositioning protocol when carrying out the craniocervical flexion test in patients with chronic cervical pain.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

About this study

Neck pain is delimited by two horizontal lines, one through the lower portion of the occipital region and one through the spinous process of the first thoracic vertebra. This pain is reproduced by neck movements or exploratory provocation tests. Scientific studies show that at least two out of three people will experience neck pain throughout life. Some of the causes are traumatism and whiplash although sometimes pain is idiopathic.

This study will verify whether the cranio-cervical flexion coordination (motor control) and muscle strength training protocol is more effective in improving muscle than the proprioception and muscle strength protocol in patients with chronic neck pain.

The project design will be a randomized controlled evaluator-blinded clinical trial with two intervention groups:

Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.

Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception. Measurements will be done at the beginning of the study, pre and post-treatment, one month and two months after treatment and throughout the six month treatment. Each session will last 45 minutes and therapy will be performed without provoking the patient symptoms.

Intervention

Experimental group 1: will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al1, 2 and exercises to increase strength-endurance on the neck flexor muscles.

Control group 2: will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of cervical pain of at least 3 months.
  • Between 18 and 55 years old.
  • Altered movement and/or loss of cervical control.
  • Pain after palpation of the muscles to be treated.

Exclusion criteria

  • Previous history of central neurological condition.
  • Previous surgery of the cervical, cranial, scapular waist, upper limb or jaw.
  • Having received specific treatment or therapy of the cervical region in the 6 months prior to the study.
  • Neck pain or headache with no musculo-skeletal causes.
  • Any other disorder that prevents physical activity.
  • Having received psychological treatment due to neck pain.
  • Patients with fibromyalgia, rheumatoid arthritis, vascular diseases, neoplasm or vestibular system pathologies.

Treatment and study plan

Motor control exercises

Other

Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles

muscle strength-endurance and proprioception

Other

Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.

Primary outcomes

  1. Craniocervical Flexion Test

    Time frame: up to six months after treatment

    This test measures the activation and resistance of the neck flexor muscles in 5 steps, with isometric contractions on the patient every 2 mmHg, increasing pressure sequentially from 20 mmHg up to 30 mmHg.

    Once carried out the test, performance will be measured by the pressure level achieved and the number of times pressure can be maintained by the patient with the correct cranioflexion movement in each level.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

The Effectiveness of Two Training Protocols When Managing Chronic Cervical Pain: Controlled Randomized Clinical Trial.

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 26, 2014
Registry last updated
Dec 2, 2015

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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