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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02351986
Date of registration: 27/01/2015
Prospective Registration: No
Primary sponsor: Universidade Federal de Sao Carlos
Public title: Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
Scientific title: Effects of Cryotherapy on Inflammatory Mediators, Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
Date of first enrolment: June 2014
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02351986
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name:     Tania Fatima Salvini, Professor
Address: 
Telephone:
Email:
Affiliation:  Universidade Federal de Sao Carlos
Key inclusion & exclusion criteria

Definition: The participants will be selected from population in general and will be
screened by the inclusion and exclusion criteria below:

Inclusion Criteria:

- The diagnosis for SIS will be based on a clinical examination and self-reported
orthopaedic history. at least 3 positive tests of: Neer impingement test, Hawkins
impingement test, Jobe test, Speed test or Gerber test, pain with passive or
isometric resisted shoulder lateral rotation, pain with active shoulder elevation and
pain with palpation of rotator cuff tendons.

Exclusion Criteria:

- Fracture, osteoporosis, malignancy, infection, and active inflammatory process,
pregnancy, systemic illnesses, physical therapy or manual therapy treatment within 6
months prior to the evaluation, signs of complete rotator cuff tear or acute
inflammation, cervicothoracic spine-related symptoms (positive cervical compression
test and excessive kyphosis), scoliosis, glenohumeral instability (positive
apprehension, anterior drawer, or sulcus tests), or previous upper extremity fracture
or shoulder surgery.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Pain
Inflammation
Intervention(s)
Procedure: physical therapy
Other: ice pack
Primary Outcome(s)
Cytokines serum levels [Time Frame: up to 96 hours post cryotherapy]
Secondary Outcome(s)
Disabilities of the Arm, Shoulder and Hand - DASH questionnaires [Time Frame: 72 hours pre cryotherapy and 96 hours post cryotherapy]
Pressure pain threshold [Time Frame: 72 hours pre cryotherapy and 96 hours post cryotherapy]
Western Ontario Rotator Cuff Index - WORC questionnaires [Time Frame: 72 hours pre cryotherapy and 96 hours post cryotherapy]
Secondary ID(s)
U1111-1162-2746
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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