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The Effectiveness of Exercises Protocol in Management of Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
motor control exercises
muscle strength-endurance and proprioception
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcalá University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

strength-endurance exercises

strength-endurance and proprioception

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2014
Last Updated
November 30, 2015
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT02225873
Brief Title
The Effectiveness of Exercises Protocol in Management of Neck Pain
Official Title
The Effectiveness of Two Training Protocols When Managing Chronic Cervical Pain: Controlled Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strength-endurance exercises
Arm Type
Experimental
Arm Description
Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.
Arm Title
strength-endurance and proprioception
Arm Type
Placebo Comparator
Arm Description
Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.
Intervention Type
Other
Intervention Name(s)
motor control exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
muscle strength-endurance and proprioception
Intervention Description
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 Outcome Measure Information:
Title
Craniocervical Flexion Test
Description
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.
Time Frame
up to six months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Gallego-Izquierdo, Dr
Organizational Affiliation
Alcala University
Official's Role
Study Chair
Facility Information:
Facility Name
Alcalá University
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain

12. IPD Sharing Statement

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The Effectiveness of Exercises Protocol in Management of Neck Pain

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