Neck PainNCT03474705
Clinical Outcomes, Viscoelastic Properties and Central Pain Mechanisms After Eccentric Training in Neck/Shoulder Pain
A study testing Eccentric Training Protocol in people with Neck Pain and Work-related Injury, run by University of Seville at 1 site in Spain.
Trial summary
Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP, and 3) assess changes in central pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neck Pain, Work-related Injury, Shoulder Pain
- What is being tested?
- Eccentric Training Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2018to 30 Sep 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck / shoulder pain has to last more than 12 weeks', with an average score higher than 2 on a 11-point Numeric Pain Rating Scale within the last 24 hours and during the week before data collection.
- All subjects will have to work for a minimum of four hours per day using a computer, should speak and understand English, and could not be involved in regular strength training of the neck/upper extremities
Who cannot join
- previous whiplash; a history of neurological or mental illnesses; consumption of pain killers within the last 24 hours; drug addiction, defined as the use of cannabis, opioids or other drugs; fibromyalgia; previous cervical spine or upper limb surgery; carpal tunnel syndrome; concomitant injury or pain from the lumbar spine; and heart diseases or hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes, Muscle Stiffness and Creep, and Central Pain Mechanisms Are Improved After Eccentric Training in Female Computer Users With Chronic Neck/Shoulder Pain
Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP, and 3) assess changes in central pain responses after training.
Methods: In part A, twenty office workers with NSP will be compared with 20 healthy controls. In part B, the NSP group will undergo a 5-week eccentric training program. Participants will report their pain intensity, and complete the Neck Disability Index, and the Disabilities of the Arm, Shoulder and Hand questionnaire. Pressure pain thresholds (PPTs) will be assessed over the neck and forearm. Cuff algometry will identify pain detection (PDT) and tolerance thresholds (PTT). TSP will be evaluated by visual analogue scale pain scores during 10 repetitive cuff stimulations. CPM will be calculated as the difference in PDT with and without a conditioning painful stimulus. Outcomes will be measured at baseline and post-intervention.
- Conditions
- Neck Pain, Work-related Injury, Shoulder Pain
- Being tested
- Eccentric Training Protocol
- Keywords
- Clinical Pain, Hyperalgesia, Intervention, Musculoskeletal disorders, Computer Work, Strength Training
- Medical subject headings
- Neck Pain, Shoulder Pain, Hyperalgesia, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric Training ProtocolDevice
A custom-built dynamic shoulder dynamometer (Aalborg University, Aalborg, Denmark) will be used. Participants will be seated with back support and no feet support. The maximal voluntary contraction (MVC) of the painful side will be assessed. Sessions will start with a 5-min warm-up. After that, participants will sit in the dynamometer, and the range of shoulder elevation (highest and lowest vertical position) will be measured for the affected side. During training, subjects will have to counteract a dynamometer vertical force from the highest to the lowest shoulder position at a force equal to 60% (training sessions 1-3), 70% (training sessions 4-6), and 80% (training sessions 7-10) of the MVC recorded during baseline. Three bouts of 10 repetitions (sessions 1-3), 8 repetitions (sessions 4-6) and 6 repetitions (sessions 7-10) will be performed, with a 3-second rest between contractions and a 2-minute break between bouts.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Training Group | Experimental | Eccentric training of the upper trapezius muscles. The intervention will consist of ten sessions of 25-30 minutes (twice a week over 5 consecutive weeks) of eccentric exercises of the shoulder muscles, as neural activation increases after 4 weeks of eccentric training. The total duration of the intervention will be 2 hours and a half. Receives: Device: Eccentric Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity, assessed by a 11-point Numeric Pain Rating Scale (NPRS)
It will be measured the worst pain within the last 24 hours and the average pain intensity during the previous week
Measured: Change from Baseline to Pain Level after a two-week intervention protocol
Upper limb function, assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
The DASH questionnaire is the most recommended scale to assess individuals with shoulder disorders
Measured: Change from Baseline to Upper extremity Disability Level after a two-week intervention protocol
Neck disability, assessed by the Neck Disability Index (NDI)
The NDI is a valid and reliable tool, frequently used to assess functionality in workplace interventions
Measured: Change from Baseline to Neck Disability Level after a two-week intervention protocol
Secondary outcomes (7)
Pressure Pain Threshold, assessed by Manual Pressure Algometry
A handheld electronic pressure algometer with a 1-cm2 contact probe will be used. Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over the middle point of the upper trapezius muscle belly, and the muscle bellies of the extensor carpi radialis brevis and the extensor carpi ulnaris. A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis. Pressure algometry is reliable in healthy individuals, and in neck pain.
Measured: Change from Baseline to after a two-week intervention protocol
Cuff Algometry
A computer-controlled cuff-algometer (Aalborg University, Aalborg, Denmark) will be used to evaluate distal hyperalgesia at the lower legs by means of pain detection (PDT) and tolerance threshold (PTT). A single 13-cm-wide cuff (VBM, Sulz am Neckar, Germany) will be wrapped around the gastrocnemius muscles, at the level with the maximum circumference, on both sides. The cuff pressure will be increased by 1 kPa/s, with the maximal pressure set up at 100 kPa. Participants will be told to rate their pain intensity on a 10-cm electronic Visual Analogue Scale (VAS), and to press a button to release the cuff inflation when the pain was unbearable (PTT). PDT will be considered as the pressure corresponding to the first VAS rating more than 1 cm. This protocol is highly reliable and an examiner-independent procedure.
Measured: Change from Baseline to after a two-week intervention protocol
Temporal Summation of Pain (TPS)
TSP will be collected from the painful/most painful side, and the same side matched on dominance for controls. Ten consecutive cuff pressure stimuli (1-second duration, 1-second break interval) will be delivered by inflating the cuff chamber at the same intensity than the PTT . During intervals, a non-painful pressure of 1 kPa will be applied. Participants will have to continuously rate their pain on the electronic VAS without returning to zero during breaks. TSP will be defined as the difference between the mean VAS score from the eight to the tenth stimulus (VAS-II) and the mean VAS value from the first to the fourth stimulus (VAS-I) (e.g., VAS-II minus VAS-I). A higher value indicates enhanced TSP.
Measured: Change from Baseline to after a two-week intervention protocol
Conditioned Pain Modulation
Experimental tonic pain will be evoked on the contralateral leg (at the gastrocnemius muscle) with a continuous cuff-induced painful stimulus, which will be set at 70% of the PTT on that side (conditioning stimulus). Simultaneously, PDT and PTT will be evaluated (test stimulus) on the leg corresponding to the painful/most painful side (NSP group), or the dominant side (control group). The CPM-effect will be defined as the difference between PDT during versus before conditioning. A lower CPM value indicates a less efficient central pain inhibition.
Measured: Change from Baseline to after a two-week intervention protocol
Shoulder Force
The maximal voluntary contraction (MVC) will be measured with a custom built dynamic shoulder dynamometer (Aalborg University, Aalborg, Denmark). Participants will be in a seated upright position with back support and no feet support, and, when required, a corselet will be used to prevent uneven loading of the spine. First, participants will be instructed to raise and lower both shoulders at the same time as much as possible. After that, they will be told to place their shoulders in a relaxed position, and when the pad of the dynamometer is lowered to this level, they will be verbally encouraged to perform a shrug shoulder force in isometric condition for 3 seconds. Recordings will be made twice (2-min break between every test) on the painful shoulder, and the average value will be used for further analysis.
Measured: Change from Baseline to after a two-week intervention protocol
Muscle Stiffness
The biomechanical properties of the upper trapezius will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.
Measured: Change from Baseline to after a two-week intervention protocol
Muscle Creep
The upper trapezius muscle creep will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.
Measured: Change from Baseline to after a two-week intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start2 May 2018
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Lars Arendt-Nielsen, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474705
- Sponsor's protocol ID
- AMHRizo
- Status last verified
- Dec 2018
- First submitted
- 5 Mar 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes, Muscle Stiffness and Creep, and Central Pain Mechanisms Are Improved After Eccentric Training in Female Computer Users With Chronic Neck/Shoulder Pain
- ClinicalTrials.gov ID
- NCT03474705
- Acronym / sponsor ID
- AMHRizo
- Conditions
- Neck Pain, Work-related Injury, Shoulder Pain
- Keywords
- Clinical Pain, Hyperalgesia, Intervention, Musculoskeletal disorders, Computer Work, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- 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.
Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP, and 3) assess changes in central pain responses after training.
Methods: In part A, twenty office workers with NSP will be compared with 20 healthy controls. In part B, the NSP group will undergo a 5-week eccentric training program. Participants will report their pain intensity, and complete the Neck Disability Index, and the Disabilities of the Arm, Shoulder and Hand questionnaire. Pressure pain thresholds (PPTs) will be assessed over the neck and forearm. Cuff algometry will identify pain detection (PDT) and tolerance thresholds (PTT). TSP will be evaluated by visual analogue scale pain scores during 10 repetitive cuff stimulations. CPM will be calculated as the difference in PDT with and without a conditioning painful stimulus. Outcomes will be measured at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eccentric Training Group | Experimental | Device: Eccentric Training ProtocolEccentric training of the upper trapezius muscles. The intervention will consist of ten sessions of 25-30 minutes (twice a week over 5 consecutive weeks) of eccentric exercises of the shoulder muscles, as neural activation increases after 4 weeks of eccentric training. The total duration of the intervention will be 2 hours and a half. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neck / shoulder pain has to last more than 12 weeks', with an average score higher than 2 on a 11-point Numeric Pain Rating Scale within the last 24 hours and during the week before data collection.
- All subjects will have to work for a minimum of four hours per day using a computer, should speak and understand English, and could not be involved in regular strength training of the neck/upper extremities
Key exclusion criteria (1 listed)
- previous whiplash; a history of neurological or mental illnesses; consumption of pain killers within the last 24 hours; drug addiction, defined as the use of cannabis, opioids or other drugs; fibromyalgia; previous cervical spine or upper limb surgery; carpal tunnel syndrome; concomitant injury or pain from the lumbar spine; and heart diseases or hypertension.
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 |
|---|---|---|
| Eccentric Training ProtocolA custom-built dynamic shoulder dynamometer (Aalborg University, Aalborg, Denmark) will be used. Participants will be seated with back support and no feet support. The maximal voluntary contraction (MVC) of the painful side will be assessed. Sessions will start with a 5-min warm-up. After that, participants will sit in the dynamometer, and the range of shoulder elevation (highest and lowest vertical position) will be measured for the affected side. During training, subjects will have to counteract a dynamometer vertical force from the highest to the lowest shoulder position at a force equal to 60% (training sessions 1-3), 70% (training sessions 4-6), and 80% (training sessions 7-10) of the MVC recorded during baseline. Three bouts of 10 repetitions (sessions 1-3), 8 repetitions (sessions 4-6) and 6 repetitions (sessions 7-10) will be performed, with a 3-second rest between contractions and a 2-minute break between bouts. | Device | Eccentric Training Group |
Primary outcome
Pain Intensity, assessed by a 11-point Numeric Pain Rating Scale (NPRS)
Time frame: Change from Baseline to Pain Level after a two-week intervention protocol
It will be measured the worst pain within the last 24 hours and the average pain intensity during the previous week
Upper limb function, assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Change from Baseline to Upper extremity Disability Level after a two-week intervention protocol
The DASH questionnaire is the most recommended scale to assess individuals with shoulder disorders
Neck disability, assessed by the Neck Disability Index (NDI)
Time frame: Change from Baseline to Neck Disability Level after a two-week intervention protocol
The NDI is a valid and reliable tool, frequently used to assess functionality in workplace interventions
7 secondary outcomes
Pressure Pain Threshold, assessed by Manual Pressure Algometry
Time frame: Change from Baseline to after a two-week intervention protocol
Cuff Algometry
Time frame: Change from Baseline to after a two-week intervention protocol
Temporal Summation of Pain (TPS)
Time frame: Change from Baseline to after a two-week intervention protocol
Conditioned Pain Modulation
Time frame: Change from Baseline to after a two-week intervention protocol
Shoulder Force
Time frame: Change from Baseline to after a two-week intervention protocol
Muscle Stiffness
Time frame: Change from Baseline to after a two-week intervention protocol
Muscle Creep
Time frame: Change from Baseline to after a two-week intervention protocol
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 27 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lars Arendt-Nielsen, PhD study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Training Protocol in people with Neck Pain and Work-related Injury, run by University of Seville 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 1 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 27 Dec 2018. 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?
Pain Intensity, assessed by a 11-point Numeric Pain Rating Scale (NPRS) (time frame: Change from Baseline to Pain Level after a two-week intervention protocol). The study lists 3 primary outcomes in all. 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 27 Dec 2018.