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

NCT03474705 | Completed DMC

• 1 other identifier: AMHRizo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Work-related Injury; Shoulder Pain

Keywords

Clinical Pain; Hyperalgesia; Intervention; Musculoskeletal disorders; Computer Work; Strength Training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Pressure Pain Threshold, assessed by Manual Pressure Algometry

  Change from Baseline to after a two-week intervention protocol

• Cuff Algometry

  Change from Baseline to after a two-week intervention protocol

• Temporal Summation of Pain (TPS)

  Change from Baseline to after a two-week intervention protocol

• Conditioned Pain Modulation

  Change from Baseline to after a two-week intervention protocol

• Shoulder Force

  Change from Baseline to after a two-week intervention protocol

Study Arms (1)

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.

Device: Eccentric Training Protocol

Interventions

Eccentric Training Protocol DEVICE

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.

Eccentric Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead
• Aalborg University: collaborator

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain; Hyperalgesia; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Lars Arendt-Nielsen, PhD

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 22, 2018
• Study Start: May 2, 2018
• Primary Completion: August 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

ES (1)