NCT02396550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

March 11, 2015

Last Update Submit

October 17, 2016

Conditions

Tennis Elbow

Keywords

Expectations

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    measured with the Visual Analogue Scale (VAS)

    0 - 10 days

Secondary Outcomes (3)

  • Threshold Pressure Pain

    0 - 10 days

  • Perceived Disability

    0-10 days

  • Kinesiophobia

    0 - 10 days

Study Arms (2)

Positive Expectations

EXPERIMENTAL

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

Behavioral: Positive ExpectationsProcedure: Mobilization with movement

Neutral Expectations

EXPERIMENTAL

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

Procedure: Mobilization with movement

Interventions

Positive ExpectationsBEHAVIORAL

Give positive expectation of the treatment efficacy to patients

Positive Expectations
Mobilization with movementPROCEDURE

Give neutral expectation of the treatment efficacy to patients

Neutral ExpectationsPositive Expectations

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lateral Epicondylalgia Diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raúl Ferrer Peña

Arganda, Madrid, 28500, Spain

Location

Related 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.

    PMID: 22294849BACKGROUND

  • 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.

    PMID: 18267029BACKGROUND

  • 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.

    PMID: 24361109BACKGROUND

  • 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.

    PMID: 12665408BACKGROUND

  • 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.

    PMID: 11673930BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Movement

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 24, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

ES(1)