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

NCT02351986 | Completed

• 1 other identifier: U1111-1162-2746
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inflammation

Keywords

subacromial impingement; physical therapy; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Cytokines serum levels

  up to 96 hours post cryotherapy

Secondary Outcomes (3)

• 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

Study Arms (2)

Subacromial Impingement Syndrome

EXPERIMENTAL

Subjects between 18 to 45 years, with Subacromial Impingement Syndrome at least one week.

Procedure: physical therapy; Other: ice pack

Control

NO INTERVENTION

Healthy subjects between 18 to 45 years.

Interventions

physical therapy PROCEDURE

A 20 minutes ice pack cryotherapy applied for 4 consecutive days

Subacromial Impingement Syndrome

ice pack OTHER

Subacromial Impingement Syndrome

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

UFSCar Physical therapy Department

São Carlos, São Paulo, 13.565-905, Brazil

Location

MeSH Terms

Conditions

Pain; Inflammation; Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Tania Fatima Salvini, Professor

  Universidade Federal de Sao Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

BR (1)