- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950909
Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Valencia, Spain, 46010
- University of Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emphasized 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.
|
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
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.
|
|
Experimental: General exercise group
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
|
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
. The patient was asked to fix his gaze at an object lying between both hands.
Extension consequently occurred in the entire cervical spine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: 3 months
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Variation in the Neck Disability Index scale
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain intensity (Visual Analogue Scale)
Time Frame: 6 months
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Variation of 2 or more in the Scale
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6 months
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Range of motion
Time Frame: 7 weeks
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Measurements in goniometric degrees for neck flexion, extension, sidebending (left and right) and rotation (left and right)
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7 weeks
|
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Pressure pain threshold
Time Frame: 7 weeks
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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
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7 weeks
|
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Global Rating of Change scale
Time Frame: 7 weeks
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Modification of the perceived pain and disability status with the questionary
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7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moises Giménez-Costa, Investigator, University of Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1472552616890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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