Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
Primary Purpose
Pain, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical therapy
ice pack
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring subacromial impingement, physical therapy, cryotherapy
Eligibility 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.
Sites / Locations
- UFSCar Physical therapy Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Subacromial Impingement Syndrome
Control
Arm Description
Subjects between 18 to 45 years, with Subacromial Impingement Syndrome at least one week.
Healthy subjects between 18 to 45 years.
Outcomes
Primary Outcome Measures
Cytokines serum levels
Secondary Outcome Measures
Pressure pain threshold
Disabilities of the Arm, Shoulder and Hand - DASH questionnaires
Western Ontario Rotator Cuff Index - WORC questionnaires
Full Information
NCT ID
NCT02351986
First Posted
January 27, 2015
Last Updated
March 21, 2016
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT02351986
Brief Title
Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
Official Title
Effects of Cryotherapy on Inflammatory Mediators, Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
5. Study Description
Brief Summary
Background: Subacromial impingement syndrome (SIS) is a chronic and disabling disease, characterized by compression and mechanical abrasion of the tendons of the rotator cuff muscles, subacromial bursa and tendon of the long head of the biceps against the anterior surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm elevation movement. After the trauma, inflammatory processes initiate and may lead to loss of function when untreated. This inflammation leads the release of cytokines (IL-6, IL-10, IL-1β and TNF-α) whose acts as inflammatory mediators. Physical therapy works in treating SIS with the goal of reducing pain and inflammatory process. Cryotherapy is widely used in physical therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and easy application. Objective: The aim of the study is to evaluate the effects of a cryotherapy protocol, applied on shoulder of subjects with SIS, on serum inflammatory mediators (cytokines) and local pressure pain threshold. Possible changes in function and pain will also be evaluated. Materials and Methods: 30 subjects will be selected and share in two groups, 15 healthy subjects and 15 subjects with SIS. Function assessments and quality of life will be held using the DASH and WORC questionnaires. Cryotherapy will be applied for 4 consecutive days, lasting 20 minutes without interruption through ice pack over the shoulder of SIS carriers. For the blood samples, 20ml of blood will be collected at the first and last day of the intervention, and then stored at -80 ° C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation
Keywords
subacromial impingement, physical therapy, cryotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subacromial Impingement Syndrome
Arm Type
Experimental
Arm Description
Subjects between 18 to 45 years, with Subacromial Impingement Syndrome at least one week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy subjects between 18 to 45 years.
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Intervention Description
A 20 minutes ice pack cryotherapy applied for 4 consecutive days
Intervention Type
Other
Intervention Name(s)
ice pack
Primary Outcome Measure Information:
Title
Cytokines serum levels
Time Frame
up to 96 hours post cryotherapy
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Time Frame
72 hours pre cryotherapy and 96 hours post cryotherapy
Title
Disabilities of the Arm, Shoulder and Hand - DASH questionnaires
Time Frame
72 hours pre cryotherapy and 96 hours post cryotherapy
Title
Western Ontario Rotator Cuff Index - WORC questionnaires
Time Frame
72 hours pre cryotherapy and 96 hours post cryotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Fatima Salvini, Professor
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Director
Facility Information:
Facility Name
UFSCar Physical therapy Department
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13.565-905
Country
Brazil
12. IPD Sharing Statement
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Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.
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