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

NCT ID: NCT02396550

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Positive Expectations

Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive

Group Type EXPERIMENTAL

Positive Expectations

Intervention Type BEHAVIORAL

Give positive expectation of the treatment efficacy to patients

Mobilization with movement

Intervention Type PROCEDURE

Give neutral expectation of the treatment efficacy to patients

Neutral Expectations

Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral

Group Type EXPERIMENTAL

Mobilization with movement

Intervention Type PROCEDURE

Give neutral expectation of the treatment efficacy to patients

Interventions

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Positive Expectations

Give positive expectation of the treatment efficacy to patients

Intervention Type BEHAVIORAL

Mobilization with movement

Give neutral expectation of the treatment efficacy to patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Lateral Epicondylalgia Diagnosis

Exclusion Criteria

* Previous Treatment with Manual Therapy
* Previous Treatment with injection 6 months before
* Radiculopathy
* Bilateral Symptoms
* Fracture
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Raúl Ferrer Peña

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Raúl Ferrer Peña

Arganda, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22294849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18267029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24361109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12665408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11673930 (View on PubMed)

Other Identifiers

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PI-1900

Identifier Type: -

Identifier Source: org_study_id

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