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

Effects of Cryotherapy on Inflammatory Mediators, 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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation
• Intervention / Treatment: Procedure: physical therapy; Other: ice pack

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13.565-905
      • UFSCar Physical therapy Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subacromial Impingement Syndrome; Subjects between 18 to 45 years, with Subacromial Impingement Syndrome at least one week.	Procedure: physical therapy; A 20 minutes ice pack cryotherapy applied for 4 consecutive days; Other: ice pack
No Intervention: Control; Healthy subjects between 18 to 45 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cytokines serum levels	up to 96 hours post cryotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Pressure pain threshold	72 hours pre cryotherapy and 96 hours post cryotherapy
Disabilities of the Arm, Shoulder and Hand - DASH questionnaires	72 hours pre cryotherapy and 96 hours post cryotherapy
Western Ontario Rotator Cuff Index - WORC questionnaires	72 hours pre cryotherapy and 96 hours post cryotherapy

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Study Director: Tania Fatima Salvini, Professor, Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 21, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: cryotherapy; physical therapy; subacromial impingement
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Inflammation; Shoulder Impingement Syndrome
• Other Study ID Numbers: U1111-1162-2746