Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).

NCT03326466 | Unknown DMC

• 1 other identifier: SAP-CNSS
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In this case-control study, the investigators compare shoulder muscle function, pain, and central nervous system sensitization in patients with Subacromial Pain (SAP) to that in healthy controls. The investigators also examine if a relationship exists between shoulder symptom duration and central sensitization, shoulder muscle function and shoulder pain distribution in patients with SAP.

Conditions

Subacromial Impingement Syndrome; Central Nervous System Sensitization

Keywords

Subacromial Impingement Syndrome; Central Nervous System Sensitization; Muscle Function; EMG; Force Steadiness; CUFF Algometry; Manual Algometry; Pain; Maximal Voluntary Isometric Contraction

Outcome Measures

Primary Outcomes (9)

• Maximal Voluntary Strength.

  Unit of Measure: Nm/Kg.

  Baseline assessment, no follow-up (cross-sectional study).

• Submaximal Voluntary Force Steadiness

  Unit of Measure: Nm/Kg.

  Baseline assessment, no follow-up (cross-sectional study).

• Maximal EMG

  Unit of Measure: mV/s. Will be recorded during the measurement of Maximal Voluntary Strength.

  Baseline assessment, no follow-up (cross-sectional study).

• Submaximal EMG.

  Unit of Measure: mV/s. Will be recorded during the Measurement of Force Steadiness.

  Baseline assessment, no follow-up (cross-sectional study).

• Central Nervous System Sensitization - Manual Algometry.

  Unit of Measure: kPa/s

  Baseline assessment, no follow-up (cross-sectional study).

• Central Nervous System Sensitization - Cuff Algometry.

  Unit of Measure: kPa/s.

  Baseline assessment, no follow-up (cross-sectional study).

• Patient Reported Outcome - Pain Mapping.

  Subject will draw their pain as accurately as possible on a high resolution 3D body schema. Area of Pain is quantified as total number of pixels, and will be expressed as percentage of body area.

  Baseline assessment, no follow-up (cross-sectional study).

• Patient Reported Outcome - Shoulder Pain And Disability Index (SPADI).

  Questionnaire contains 13 items with a possible score from 0-100 (0=no disability).

  Baseline assessment, no follow-up (cross-sectional study).

• Patient Reported Outcome - Pain Catastrophizing Scale (PCS).

  Questionnaire contains 13 items with a possible score 0-52. Higher score indicates higher level of pain catastrophizing.

  Baseline assessment, no follow-up (cross-sectional study).

Study Arms (2)

Patients with SAP

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subacromial Pain.

You may qualify if:

• Have had SAP during the last two weeks or more.
• Have positive results from minimum 3 out of 5 clinical tests.
• Have experienced pain ranking 4 or above on the VRS scale within the last 7 days.
• Are able to speak and understand Danish.
• Have given informed consent to participate in the study after they have fully understood the content of the study.

You may not qualify if:

• Have acquired traumatic shoulder injury, and this is onset/cause for current shoulder pain, e.g. fall on shoulder.
• Have received a corticosteroid injection within the last six weeks.
• Report having had a shoulder fracture within 6 months.
• Report having had surgery on the affected shoulder.
• Report having radiologically verified glenohumeral osteoarthritis.
• Have a luxation or sub-luxation of the glenohumeral or the acromioclavicular joint, clinically suspected labrum lesion, clinically suspected complete traumatic tear of the rotator cuff, frozen shoulder, suspected competing diagnoses (i.e. rheumatoid arthritis, cancer, neurological disorders, and fibromyalgia).
• Have a history of diagnosed major psychiatric disorder.
• Have a history of illicit drug use; be currently abusing alcohol or currently withdrawing from alcohol abuse.
• Have a history of heart disease.
• Are pregnant.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C).: collaborator
• Metropolitan University College: collaborator
• Center for Neuroplasticity and Pain (CNAP).: collaborator
• National Research Center for the Working Environment.: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Sealand, 2650, Denmark

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Bandholm, PhD

  Professor, Head of Research, PMR-C.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 31, 2017
• Study Start: November 13, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)