The Effectiveness of Exercises Protocol in Management of Neck Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: motor control exercises; Other: muscle strength-endurance and proprioception

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28871
      • Alcala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: strength-endurance exercises; Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.	Other: motor control exercises; 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
Placebo Comparator: strength-endurance and proprioception; Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.	Other: muscle strength-endurance and proprioception; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craniocervical Flexion Test	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.	up to six months after treatment

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 24, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: M2013/046/20140528