Clinical Outcomes, Viscoelastic Properties and Central Pain Mechanisms After Eccentric Training in Neck/Shoulder Pain

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474705
• Other study ID #: AMHRizo
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2018
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neck Pain
• Shoulder Pain
• Work-related Injury

Intervention

Device:
• Eccentric Training Protocol
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.

Locations

Country	Name	City	State
Spain	University of Sevilla	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
University of Seville	Aalborg University

Country where clinical trial is conducted

Spain, 

Outcome

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