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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03326466
Other study ID # SAP-CNSS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 13, 2017
Est. completion date July 31, 2020

Study information

Verified date February 2019
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre Sealand

Sponsors (5)

Lead Sponsor Collaborator
Hvidovre University Hospital Center for Neuroplasticity and Pain (CNAP)., National Research Center for the Working Environment., Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C)., School of Physiotherapy, Metropolitan University College Copenhagen.

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Voluntary Strength. Unit of Measure: Nm/Kg. Baseline assessment, no follow-up (cross-sectional study).
Primary Submaximal Voluntary Force Steadiness Unit of Measure: Nm/Kg. Baseline assessment, no follow-up (cross-sectional study).
Primary 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).
Primary Submaximal EMG. Unit of Measure: mV/s. Will be recorded during the Measurement of Force Steadiness. Baseline assessment, no follow-up (cross-sectional study).
Primary Central Nervous System Sensitization - Manual Algometry. Unit of Measure: kPa/s Baseline assessment, no follow-up (cross-sectional study).
Primary Central Nervous System Sensitization - Cuff Algometry. Unit of Measure: kPa/s. Baseline assessment, no follow-up (cross-sectional study).
Primary 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).
Primary 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).
Primary 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).
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