Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement

October 17, 2016 updated by: Raúl Ferrer Peña, University of Alcala

Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial

Lateral epicondylalgia affects people of both gender between 1 and 3% of the world population, with up to 15% in the working population reaching an average of 12 weeks off work for this reason. One of the conservative treatments that have shown effective is the mobilization with movement, whose mechanisms of action are not known. According Bialosky et al., possible effects of manual therapy are based on the neurophysiological mechanisms at peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the placebo effect, which is influenced by psychological factors such as conditioning and expectations.

Changing expectations to determine the influence on the treatment has been studied in healthy subjects, showing improvement with positive expectations and worsening to negative and neutral expectations.

However the result of modifying the previous expectations for treatment in patients with pain has not been studied.

The aim of our study is to test the influence that positive expectations have on the effectiveness of treatment with mobilization with movement in patients with lateral epicondylalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Arganda del Rey, Madrid, Spain, 28500
        • Raúl Ferrer Peña

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lateral Epicondylalgia Diagnosis

Exclusion Criteria:

  • Previous Treatment with Manual Therapy
  • Previous Treatment with injection 6 months before
  • Radiculopathy
  • Bilateral Symptoms
  • Fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive Expectations
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive
Behavioral: Positive Expectations
Give positive expectation of the treatment efficacy to patients
Procedure: Mobilization with movement
Give neutral expectation of the treatment efficacy to patients
Experimental: Neutral Expectations
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral
Procedure: Mobilization with movement
Give neutral expectation of the treatment efficacy to patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 0 - 10 days
measured with the Visual Analogue Scale (VAS)
0 - 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threshold Pressure Pain
Time Frame: 0 - 10 days
measured with algometry
0 - 10 days
Perceived Disability
Time Frame: 0-10 days
with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire
0-10 days
Kinesiophobia
Time Frame: 0 - 10 days
with the Tampa Scale of Kinesiophobia
0 - 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-1900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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