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

Tennis Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396550
• Other study ID #: PI-1900
• Status: Completed
• Phase: N/A
• First received: March 11, 2015
• Last updated: October 17, 2016
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Lateral Epicondylalgia Diagnosis

Exclusion Criteria:

• Previous Treatment with Manual Therapy

• Previous Treatment with injection 6 months before

• Radiculopathy

• Bilateral Symptoms

• Fracture

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
Spain	Raúl Ferrer Peña	Arganda del Rey	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	measured with the Visual Analogue Scale (VAS)	0 - 10 days	No
Secondary	Threshold Pressure Pain	measured with algometry	0 - 10 days	No
Secondary	Perceived Disability	with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire	0-10 days	No
Secondary	Kinesiophobia	with the Tampa Scale of Kinesiophobia	0 - 10 days	No