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

Primary Purpose

Neck Pain, Work-related Injury, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Eccentric Training Protocol
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Clinical Pain, Hyperalgesia, Intervention, Musculoskeletal disorders, Computer Work, Strength Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sevilla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eccentric Training Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 5, 2018
Last Updated
December 26, 2018
Sponsor
University of Seville
Collaborators
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03474705
Brief Title
Clinical Outcomes, Viscoelastic Properties and Central Pain Mechanisms After Eccentric Training in Neck/Shoulder Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Work-related Injury, Shoulder Pain
Keywords
Clinical Pain, Hyperalgesia, Intervention, Musculoskeletal disorders, Computer Work, Strength Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Eccentric Training Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity, assessed by a 11-point Numeric Pain Rating Scale (NPRS)
Description
It will be measured the worst pain within the last 24 hours and the average pain intensity during the previous week
Time Frame
Change from Baseline to Pain Level after a two-week intervention protocol
Title
Upper limb function, assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
The DASH questionnaire is the most recommended scale to assess individuals with shoulder disorders
Time Frame
Change from Baseline to Upper extremity Disability Level after a two-week intervention protocol
Title
Neck disability, assessed by the Neck Disability Index (NDI)
Description
The NDI is a valid and reliable tool, frequently used to assess functionality in workplace interventions
Time Frame
Change from Baseline to Neck Disability Level after a two-week intervention protocol
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold, assessed by Manual Pressure Algometry
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Cuff Algometry
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Temporal Summation of Pain (TPS)
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Conditioned Pain Modulation
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Shoulder Force
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Muscle Stiffness
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol
Title
Muscle Creep
Description
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.
Time Frame
Change from Baseline to after a two-week intervention protocol

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Arendt-Nielsen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Study Director
Facility Information:
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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