Clinical trial NCT02396550: Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
Official title: Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Keywords: Expectations
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Lateral Epicondylalgia Diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Pain Intensity
timeFrame: 0 - 10 days
Secondary outcomes:
measure: Threshold Pressure Pain
timeFrame: 0 - 10 days
measure: Perceived Disability
timeFrame: 0-10 days
measure: Kinesiophobia
timeFrame: 0 - 10 days
Other outcomes:
Locations:
city: Arganda del Rey
country: Spain
facility: Raúl Ferrer Peña
state: Madrid
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.