Effects of Cryotherapy on Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.

Pain Clinical Trial

Official title:

Effects of Cryotherapy on Inflammatory Mediators, Joint Function and Pressure Pain Threshold in Patients With Subacromial Impingement Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351986
• Other study ID #: U1111-1162-2746
• Status: Completed
• Phase: N/A
• First received: January 27, 2015
• Last updated: March 21, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Pain
• Shoulder Impingement Syndrome

Intervention

Procedure:
• physical therapy
A 20 minutes ice pack cryotherapy applied for 4 consecutive days

Other:
• ice pack

Locations

Country	Name	City	State
Brazil	UFSCar Physical therapy Department	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines serum levels		up to 96 hours post cryotherapy	Yes
Secondary	Pressure pain threshold		72 hours pre cryotherapy and 96 hours post cryotherapy	Yes
Secondary	Disabilities of the Arm, Shoulder and Hand - DASH questionnaires		72 hours pre cryotherapy and 96 hours post cryotherapy	Yes
Secondary	Western Ontario Rotator Cuff Index - WORC questionnaires		72 hours pre cryotherapy and 96 hours post cryotherapy	Yes