Neck Pain Clinical Trial
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
NCT number | NCT03474705 |
Other study ID # | AMHRizo |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2018 |
Est. completion date | September 30, 2018 |
Verified date | December 2018 |
Source | University of Seville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 30, 2018 |
Est. primary completion date | August 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
University of Seville | Aalborg University |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from Baseline to Pain Level after a two-week intervention protocol | |
Primary | 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 | Change from Baseline to Upper extremity Disability Level after a two-week intervention protocol | |
Primary | 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 | Change from Baseline to Neck Disability Level after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol | |
Secondary | 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. | Change from Baseline to after a two-week intervention protocol |
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