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

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ClinicalTrials.gov Identifier: NCT02396550
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Raúl Ferrer Peña, Universidad Autonoma de Madrid

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tennis Elbow Behavioral: Positive Expectations Procedure: Mobilization with movement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 0 - 10 days ]
    measured with the Visual Analogue Scale (VAS)


Secondary Outcome Measures :
  1. Threshold Pressure Pain [ Time Frame: 0 - 10 days ]
    measured with algometry

  2. Perceived Disability [ Time Frame: 0-10 days ]
    with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire

  3. Kinesiophobia [ Time Frame: 0 - 10 days ]
    with the Tampa Scale of Kinesiophobia



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lateral Epicondylalgia Diagnosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396550


Locations
Spain
Raúl Ferrer Peña
Arganda del Rey, Madrid, Spain, 28500
Sponsors and Collaborators
University of Alcala

Publications:
Responsible Party: Raúl Ferrer Peña, Prof., Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02396550     History of Changes
Other Study ID Numbers: PI-1900
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Raúl Ferrer Peña, Universidad Autonoma de Madrid:
Expectations

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries