Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
Primary Purpose
Tennis Elbow
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positive Expectations
Mobilization with movement
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring Expectations
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
Sites / Locations
- Raúl Ferrer Peña
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Positive Expectations
Neutral Expectations
Arm Description
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral
Outcomes
Primary Outcome Measures
Pain Intensity
measured with the Visual Analogue Scale (VAS)
Secondary Outcome Measures
Threshold Pressure Pain
measured with algometry
Perceived Disability
with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire
Kinesiophobia
with the Tampa Scale of Kinesiophobia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02396550
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Expectations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive Expectations
Arm Type
Experimental
Arm Description
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive
Arm Title
Neutral Expectations
Arm Type
Experimental
Arm Description
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral
Intervention Type
Behavioral
Intervention Name(s)
Positive Expectations
Intervention Description
Give positive expectation of the treatment efficacy to patients
Intervention Type
Procedure
Intervention Name(s)
Mobilization with movement
Intervention Description
Give neutral expectation of the treatment efficacy to patients
Primary Outcome Measure Information:
Title
Pain Intensity
Description
measured with the Visual Analogue Scale (VAS)
Time Frame
0 - 10 days
Secondary Outcome Measure Information:
Title
Threshold Pressure Pain
Description
measured with algometry
Time Frame
0 - 10 days
Title
Perceived Disability
Description
with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire
Time Frame
0-10 days
Title
Kinesiophobia
Description
with the Tampa Scale of Kinesiophobia
Time Frame
0 - 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Raúl Ferrer Peña
City
Arganda del Rey
State/Province
Madrid
ZIP/Postal Code
28500
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22294849
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.
Results Reference
background
PubMed Identifier
18267029
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.
Results Reference
background
PubMed Identifier
24361109
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.
Results Reference
background
PubMed Identifier
12665408
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.
Results Reference
background
PubMed Identifier
11673930
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.
Results Reference
background
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Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
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