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

Overview

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.

Full Title of Study: “Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2016

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Positive Expectations
    • Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive
  • Experimental: Neutral Expectations
    • Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral

Clinical Trial Outcome Measures

Primary Measures

  • Pain Intensity
    • Time Frame: 0 – 10 days
    • measured with the Visual Analogue Scale (VAS)

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Lateral Epicondylalgia Diagnosis Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alcala
  • Provider of Information About this Clinical Study
    • Principal Investigator: Raúl Ferrer Peña, Prof. – Universidad Autonoma de Madrid

References

Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.

Bialosky JE, Bishop MD, Robinson ME, Barabas JA, George SZ. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjects. BMC Musculoskelet Disord. 2008 Feb 11;9:19. doi: 10.1186/1471-2474-9-19.

Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

Paungmali A, O'Leary S, Souvlis T, Vicenzino B. Hypoalgesic and sympathoexcitatory effects of mobilization with movement for lateral epicondylalgia. Phys Ther. 2003 Apr;83(4):374-83.

Vicenzino B, Paungmali A, Buratowski S, Wright A. Specific manipulative therapy treatment for chronic lateral epicondylalgia produces uniquely characteristic hypoalgesia. Man Ther. 2001 Nov;6(4):205-12. doi: 10.1054/math.2001.0411.

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