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Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Static exercise for emphasized neck extensors
Dynamic exercise for emphasized neck extensors
Static exercise for general neck extensors
Dynamic exercise for general neck extensors
Sponsored by
Moisés Giménez Costa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Therapeutic exercise, Chronic pain, Neck extensors

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate pain intensity between 3 and 5 from 10 Visual Analogue Scale)to avoid exacerbation of pain with the neck exercises;.
  • Poor performance in the neck extensor resistance test as described by Lee et al. (Lee et al., 2005) and Parazza et al. (Parazza et al., 2014) of less than 250 seconds , which justify the application of an exercise program in the neck extensors.

Exclusion Criteria:

  • neurological signs in the upper limb
  • any contraindication for EMG like known risk of having infection following clinical needle insertion, coagulation disorders or medications affecting coagulation like aspirin
  • pregnancy
  • if they had participated in a neck exercise program in the past 12 months or had cervical spine surgery.

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Emphasized exercise group

General exercise group

Arm Description

Patients in the emphasized exercise group performed exercises emphasizing the deep cervical extensor muscles applying a resistance at the level of the vertebral arch of C4 either therapeutically with the therapist's fingers or as a home exercise with the aid of a towel or belt. These exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, a dynamic exercise was added moving the head from maximal flexion to maximal extension keeping the gaze fixed at an object lying between both elbows hoping to activate more the extensors in the lower cervical spine.

Patients in the general exercise group performed exercises targeting all cervical extensor muscles including the superficial ones applying resistance at the head pushing against a wall or the therapist's hand or as a home exercise with the aid of a towel. As in the other group, these exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, the same dynamic exercise was added as in the other group with the only difference that the gaze was fixed at an object lying between both hands hoping to activate all cervical extensors

Outcomes

Primary Outcome Measures

Neck Disability Index
Variation in the Neck Disability Index scale

Secondary Outcome Measures

Neck pain intensity (Visual Analogue Scale)
Variation of 2 or more in the Scale
Range of motion
Measurements in goniometric degrees for neck flexion, extension, sidebending (left and right) and rotation (left and right)
Pressure pain threshold
Measurement using a digital algometer positioned over the zygapophyseal joints of C2 and C5 on the most painful side, or on the right side when both sides were equally painful. In addition, a remote PPT site on the right tibialis anterior
Global Rating of Change scale
Modification of the perceived pain and disability status with the questionary

Full Information

First Posted
October 25, 2016
Last Updated
September 30, 2021
Sponsor
Moisés Giménez Costa
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1. Study Identification

Unique Protocol Identification Number
NCT02950909
Brief Title
Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain
Official Title
Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 28, 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moisés Giménez Costa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study therefore is to investigate the effects on pain and disability of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and a general exercise program for all neck extensor muscles in patients with chronic neck pain. As a secondary aim , pain intensity (VAS), cervical ROM, pressure pain threshold (PPT), cervical and thoracic posture and self-perceived benefit of treatment (GROC) were measured. The investigators hypothesized that both exercise programs would have similar effects on pain alleviation and pain related disability, but that the emphasized exercise program for the deep semispinalis cervicis would improve its activation more compared to the general exercise program. The results of this study will be relevant for designing effective rehabilitation/training programs for patients with chronic neck pain.
Detailed Description
An independent group, repeated-measures study design was adopted to investigate the immediate effect of two different kinds of intervention: Emphasized exercises targeting the deep cervical extensors and general exercises targeting all neck extensors. Subjects were randomized into two exercise groups: the emphasized exercise group in which patients performed muscle contractions against resistance directly at the neck and the general exercise group in which the resistance was applied at the head. Sealed opaque envelopes were used to conceal allocation. Exercise regimes was of 6-weeks duration and started within one week of the initial assessment. All subjects received personal instruction and supervision by one experienced physiotherapist, once a week, for the duration of the whole program. Subjects received an exercise diary and were requested to practice their respective regime twice per day for the six-week duration of the trial, without provoking neck pain and with attention to correct performance of the exercises. Exercises at home occurred for a period of no longer than 15 to 20 minutes twice per day. Subjects were asked not to seek other interventions for neck pain during the duration of the study, although usual medication was not withheld. All patients performed two static exercises and one dynamic exercise. The only difference between both groups was the location of the resistance, which was in the lower cervical spine approximately at level C4 for the emphasized exercise group and at the occiput for the general exercise group. Patients in the emphasized exercise group performed exercises emphasizing the deep cervical extensor muscles applying a resistance at the level of the vertebral arch of C4 either therapeutically with the therapist's fingers or as a home exercise with the aid of a towel or belt. These exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, a dynamic exercise was added moving the head from maximal flexion to maximal extension keeping the gaze fixed at an object lying between both elbows hoping to activate more the extensors in the lower cervical spine. Patients in the general exercise group performed exercises targeting all cervical extensor muscles including the superficial ones applying resistance at the head pushing against a wall or the therapist's hand or as a home exercise with the aid of a towel. As in the other group, these exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, the same dynamic exercise was added as in the other group with the only difference that the gaze was fixed at an object lying between both hands hoping to activate all cervical extensors. The dosage for both exercise regimes required maximal muscle activation of the patient because it was shown that at this dosage the emphasized exercise results in muscle activation of about 20% to 25% MVC (Maximum Voluntary Contraction) and the general exercise of about 50% MVC (Schomacher et al., 2015). Patients were asked therefore to perform the exercises at their individual maximal force for a short time without provoking any pain neither during nor after the exercise. That is, submaximal effort without evoking pain during and after the exercises was used. All exercises were repeated each for 3 sets with a break of 1-2 minutes between the sets. The two static exercises consisted of 6 repetitions of 6 seconds hold in each position with 6 seconds rest between each contraction. The dynamic exercise was performed with 6 repetitions through the whole range of motion with 2-3 seconds for each repetition without any rest between the repetitions. A break between the repetitions was added if necessary to avoid pain (Table 1). Patients repeated the exercise session one time per week under supervision of a physiotherapist, during 6 weeks. In addition, patients performed the exercise session twice per day seven days per week at home. Each exercise session lasted about 20 - 25 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Therapeutic exercise, Chronic pain, Neck extensors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emphasized exercise group
Arm Type
Experimental
Arm Description
Patients in the emphasized exercise group performed exercises emphasizing the deep cervical extensor muscles applying a resistance at the level of the vertebral arch of C4 either therapeutically with the therapist's fingers or as a home exercise with the aid of a towel or belt. These exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, a dynamic exercise was added moving the head from maximal flexion to maximal extension keeping the gaze fixed at an object lying between both elbows hoping to activate more the extensors in the lower cervical spine.
Arm Title
General exercise group
Arm Type
Experimental
Arm Description
Patients in the general exercise group performed exercises targeting all cervical extensor muscles including the superficial ones applying resistance at the head pushing against a wall or the therapist's hand or as a home exercise with the aid of a towel. As in the other group, these exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, the same dynamic exercise was added as in the other group with the only difference that the gaze was fixed at an object lying between both hands hoping to activate all cervical extensors
Intervention Type
Procedure
Intervention Name(s)
Static exercise for emphasized neck extensors
Intervention Description
Emphasized activation of the deep neck extensors was searched for applying a localized resistance with the thumb and index finger at the level of the vertebral arch of C4 while pushing into flexion in a ventral-cranial direction, approximately parallel to the surface of the zygapophyseal joint, asking the patient to resist maximally during 6 seconds in sitting position
Intervention Type
Procedure
Intervention Name(s)
Dynamic exercise for emphasized neck extensors
Intervention Description
The patient was asked to fix his gaze at an object lying between both elbows hoping to in order to emphasize extension in the lower cervical spine and consequently activation of the extensors in this region.
Intervention Type
Procedure
Intervention Name(s)
Static exercise for general neck extensors
Intervention Description
Emphasized activation of all neck extensors was searched for applying the resistance with the therapist's hand or a wall respectively a towel at the occiput in sitting position
Intervention Type
Procedure
Intervention Name(s)
Dynamic exercise for general neck extensors
Intervention Description
. The patient was asked to fix his gaze at an object lying between both hands. Extension consequently occurred in the entire cervical spine.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Variation in the Neck Disability Index scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neck pain intensity (Visual Analogue Scale)
Description
Variation of 2 or more in the Scale
Time Frame
6 months
Title
Range of motion
Description
Measurements in goniometric degrees for neck flexion, extension, sidebending (left and right) and rotation (left and right)
Time Frame
7 weeks
Title
Pressure pain threshold
Description
Measurement using a digital algometer positioned over the zygapophyseal joints of C2 and C5 on the most painful side, or on the right side when both sides were equally painful. In addition, a remote PPT site on the right tibialis anterior
Time Frame
7 weeks
Title
Global Rating of Change scale
Description
Modification of the perceived pain and disability status with the questionary
Time Frame
7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate pain intensity between 3 and 5 from 10 Visual Analogue Scale)to avoid exacerbation of pain with the neck exercises;. Poor performance in the neck extensor resistance test as described by Lee et al. (Lee et al., 2005) and Parazza et al. (Parazza et al., 2014) of less than 250 seconds , which justify the application of an exercise program in the neck extensors. Exclusion Criteria: neurological signs in the upper limb any contraindication for EMG like known risk of having infection following clinical needle insertion, coagulation disorders or medications affecting coagulation like aspirin pregnancy if they had participated in a neck exercise program in the past 12 months or had cervical spine surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moises Giménez-Costa, Investigator
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain

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