Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
Study NCT ID:
NCT02396550
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009068', 'term': 'Movement'}], 'ancestors': [{'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '0 - 10 days', 'description': 'measured with the Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Threshold Pressure Pain', 'timeFrame': '0 - 10 days', 'description': 'measured with algometry'}, {'measure': 'Perceived Disability', 'timeFrame': '0-10 days', 'description': 'with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire'}, {'measure': 'Kinesiophobia', 'timeFrame': '0 - 10 days', 'description': 'with the Tampa Scale of Kinesiophobia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Expectations'], 'conditions': ['Tennis Elbow']}, 'referencesModule': {'references': [{'pmid': '22294849', 'type': 'BACKGROUND', '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.'}, {'pmid': '18267029', 'type': 'BACKGROUND', '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.'}, {'pmid': '24361109', 'type': 'BACKGROUND', '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.'}, {'pmid': '12665408', 'type': 'BACKGROUND', '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."}, {'pmid': '11673930', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nChanging 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.\n\nHowever the result of modifying the previous expectations for treatment in patients with pain has not been studied.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lateral Epicondylalgia Diagnosis\n\nExclusion Criteria:\n\n* Previous Treatment with Manual Therapy\n* Previous Treatment with injection 6 months before\n* Radiculopathy\n* Bilateral Symptoms\n* Fracture'}, 'identificationModule': {'nctId': 'NCT02396550', 'briefTitle': 'Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial', 'orgStudyIdInfo': {'id': 'PI-1900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Expectations', 'description': 'Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive', 'interventionNames': ['Behavioral: Positive Expectations', 'Procedure: Mobilization with movement']}, {'type': 'EXPERIMENTAL', 'label': 'Neutral Expectations', 'description': 'Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral', 'interventionNames': ['Procedure: Mobilization with movement']}], 'interventions': [{'name': 'Positive Expectations', 'type': 'BEHAVIORAL', 'description': 'Give positive expectation of the treatment efficacy to patients', 'armGroupLabels': ['Positive Expectations']}, {'name': 'Mobilization with movement', 'type': 'PROCEDURE', 'description': 'Give neutral expectation of the treatment efficacy to patients', 'armGroupLabels': ['Neutral Expectations', 'Positive Expectations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28500', 'city': 'Arganda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Raúl Ferrer Peña', 'geoPoint': {'lat': 40.30076, 'lon': -3.43722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Raúl Ferrer Peña', 'investigatorAffiliation': 'Universidad Autonoma de Madrid'}}}}