Neck PainNCT02950909
Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain
A study testing Static exercise for emphasized neck extensors, Dynamic exercise for emphasized neck extensors and Static exercise for general neck extensors in people with Neck Pain, run by Moisés Giménez Costa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Static exercise for emphasized neck extensors, Dynamic exercise for emphasized neck extensors and Static exercise for general neck extensors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Static exercise for emphasized neck extensors, Dynamic exercise for emphasized neck extensors, Static exercise for general neck extensors, Dynamic exercise for general neck extensors
- Keywords
- Therapeutic exercise, Chronic pain, Neck extensors
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static exercise for emphasized neck extensorsProcedure or surgery
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
Dynamic exercise for emphasized neck extensorsProcedure or surgery
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.
Static exercise for general neck extensorsProcedure or surgery
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
Dynamic exercise for general neck extensorsProcedure or surgery
. The patient was asked to fix his gaze at an object lying between both hands. Extension consequently occurred in the entire cervical spine.
| Study group | Role | What they receive |
|---|---|---|
| Emphasized exercise group | Experimental | 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. Receives: Procedure: Static exercise for emphasized neck extensors; Procedure: Dynamic exercise for emphasized neck extensors |
| General exercise group | Experimental | 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 Receives: Procedure: Static exercise for general neck extensors; Procedure: Dynamic exercise for general neck extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Variation in the Neck Disability Index scale
Measured: 3 months
Secondary outcomes (4)
Neck pain intensity (Visual Analogue Scale)
Variation of 2 or more in the Scale
Measured: 6 months
Range of motion
Measurements in goniometric degrees for neck flexion, extension, sidebending (left and right) and rotation (left and right)
Measured: 7 weeks
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
Measured: 7 weeks
Global Rating of Change scale
Modification of the perceived pain and disability status with the questionary
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion28 Jun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moisés Giménez Costa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moisés Giménez Costa, University of Valencia
- Investigators
- Moises Giménez-Costa, Investigator, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950909
- Sponsor's protocol ID
- H1472552616890
- Status last verified
- Sep 2021
- First submitted
- 25 Oct 2016
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02950909
- Acronym / sponsor ID
- H1472552616890
- Conditions
- Neck Pain
- Keywords
- Therapeutic exercise, Chronic pain, Neck extensors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Moisés Giménez CostaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emphasized exercise group | Experimental | Procedure: Static exercise for emphasized neck extensors, Procedure: Dynamic exercise for emphasized neck extensorsPatients 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. |
| General exercise group | Experimental | Procedure: Static exercise for general neck extensors, Procedure: Dynamic exercise for general neck extensorsPatients 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static exercise for emphasized neck extensorsEmphasized 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 | Procedure or surgery | Emphasized exercise group |
| Dynamic exercise for emphasized neck extensorsThe 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. | Procedure or surgery | Emphasized exercise group |
| Static exercise for general neck extensorsEmphasized 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 | Procedure or surgery | General exercise group |
| Dynamic exercise for general neck extensors. The patient was asked to fix his gaze at an object lying between both hands. Extension consequently occurred in the entire cervical spine. | Procedure or surgery | General exercise group |
Primary outcome
Neck Disability Index
Time frame: 3 months
Variation in the Neck Disability Index scale
4 secondary outcomes
Neck pain intensity (Visual Analogue Scale)
Time frame: 6 months
Range of motion
Time frame: 7 weeks
Pressure pain threshold
Time frame: 7 weeks
Global Rating of Change scale
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moises Giménez-Costa, Investigator principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static exercise for emphasized neck extensors, Dynamic exercise for emphasized neck extensors and Static exercise for general neck extensors in people with Neck Pain, run by Moisés Giménez Costa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.