Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-06 @ 6:07 PM
Study NCT ID:
NCT02019134
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}, {'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Mean pain intensity measured by the daily pain intensity on the NRS', 'timeFrame': '6 months'}, {'measure': 'Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS', 'timeFrame': '3 and 6 months'}, {'measure': 'Pain acceptance', 'timeFrame': '3 and 6 months', 'description': 'German version of Chronic Pain Acceptance Questionnaire'}, {'measure': 'Stress', 'timeFrame': '3 and 6 months', 'description': 'NRS'}, {'measure': 'Suspected adverse reaction', 'timeFrame': '3 and 6 month'}, {'measure': 'Number of serious adverse event', 'timeFrame': '3 and 6 month'}, {'measure': 'medication intake', 'timeFrame': '3 and 6 months'}, {'measure': 'Number of sick leave days', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic neck pain', 'relaxation technique', 'comparative effectiveness research'], 'conditions': ['Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '34994708', 'type': 'DERIVED', 'citation': 'Pach D, Blodt S, Wang J, Keller T, Bergmann B, Rogge AA, Barth J, Icke K, Roll S, Witt CM. App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial. JMIR Mhealth Uhealth. 2022 Jan 7;10(1):e31482. doi: 10.2196/31482.'}, {'pmid': '25511185', 'type': 'DERIVED', 'citation': 'Blodt S, Pach D, Roll S, Witt CM. Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials. Trials. 2014 Dec 15;15:490. doi: 10.1186/1745-6215-15-490.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.', 'detailedDescription': 'Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.\n\nStudy design: Open single-centered randomized two-armed pragmatic trial.\n\nParticipants: 220 patients aged 18-65 years with chronic (\\>12 weeks) neck pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list)\n\nIntervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally, five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply.\n\nMain outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female or male\n* 18-65 years of age\n* chronic neck pain for at least 12 weeks\n* if additional back pain is reported, neck pain has to be predominant\n* intensity of the average neck pain ≥ 4 on the numeric rating scale (NRS) in the last week\n* presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)\n* physical and mental ability to participate in the study\n* willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by a smart phone application\n* written and oral informed consent\n\nExclusion Criteria:\n\n* neck pain caused by a known malignant disease\n* neck pain caused by trauma\n* known rheumatic disorder\n* history or planned surgery of the spinal column of the neck in the next 6 months\n* known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc\n* regular intake of analgesics (\\>1x per week) because of additional diseases\n* intake of centrally acting analgesics\n* known severe acute or chronic disorder, that do not allow participation in the therapy\n* other known diseases, that do not allow participation in the therapy\n* known alcohol or substance abuse\n* no sufficient German language skills\n* current application for a benefit\n* participation in another clinical trial during six months before the study and parallel to the study\n* conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months'}, 'identificationModule': {'nctId': 'NCT02019134', 'acronym': 'Relaxneck', 'briefTitle': 'Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'Relaxneck-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'usual care waiting list', 'description': 'Patients allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy', 'interventionNames': ['Other: ususal care']}, {'type': 'EXPERIMENTAL', 'label': 'relaxation exercise', 'description': 'Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply', 'interventionNames': ['Behavioral: relaxation exercise']}], 'interventions': [{'name': 'relaxation exercise', 'type': 'BEHAVIORAL', 'otherNames': ['meditation'], 'description': 'relaxation exercise', 'armGroupLabels': ['relaxation exercise']}, {'name': 'ususal care', 'type': 'OTHER', 'otherNames': ['waiting list'], 'armGroupLabels': ['usual care waiting list']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia M Witt, Prof. Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr. Claudia M. Witt', 'investigatorFullName': 'Claudia M. Witt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}