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Completed

NCT Number: NCT02351986

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFSCar Physical therapy Department

São Carlos, São Paulo, 13.565-905, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physical therapy

Procedure

A 20 minutes ice pack cryotherapy applied for 4 consecutive days

ice pack

Other

Primary outcomes

  1. Cytokines serum levels

    Time frame: up to 96 hours post cryotherapy

Secondary outcomes

  1. Pressure pain threshold

    Time frame: 72 hours pre cryotherapy and 96 hours post cryotherapy

  2. Disabilities of the Arm, Shoulder and Hand - DASH questionnaires

    Time frame: 72 hours pre cryotherapy and 96 hours post cryotherapy

  3. Western Ontario Rotator Cuff Index - WORC questionnaires

    Time frame: 72 hours pre cryotherapy and 96 hours post cryotherapy

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2015
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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