Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 7:55 PM
Study NCT ID:
NCT07048093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-06-14', 'studyFirstSubmitQcDate': '2025-06-28', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Pain Rating Scale', 'timeFrame': 'At enrollment (pre-intervention) and immediately after the relaxation exercise intervention or sham intervention (Day 1)', 'description': 'On the numerical pain scale, the patient will be asked, "0 means no pain at all, 10 means unbearable pain, representing the worst pain/unbearable pain you have ever experienced. On a scale of 0 to 10, how would you rate your pain?"'}, {'measure': 'Turkish Version of Core Outcome Measure Index for Neck Pain', 'timeFrame': 'At enrollment (pre-intervention)', 'description': 'The first question consists of two 10-point numerical pain scales that ask about neck and arm-shoulder pain. Whichever of these two questions receives a higher response is used. The other five questions are five point Likert-type response questions. The six items cover five dimensions: pain intensity (neck and arm/shoulder pain), neck-related function, symptom-specific well-being, overall quality of life, and disability (social and work). The total score is calculated by taking the average of all responses. To form the Core Outcome Measure Index summary score, each of the dimension scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status.'}, {'measure': 'EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver', 'timeFrame': 'At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)', 'description': 'EMG Activation Level of Sternocleidomastoid Muscle During Craniocervical Flexion Maneuver standardized with Stabilizer Pressure Biofeedback Device'}, {'measure': 'EMG Activation Level of Upper Trapezius Muscle During Standing Still', 'timeFrame': 'At enrollment (pre-intervention) and immediately after the relaxation exercise intervention (Day 1)', 'description': 'EMG Activation Level of Upper Trapezius Muscle During Standing Still'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relaxation Exercise', 'craniocervical flexion', 'upper trapezius'], 'conditions': ['Non Specific Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '26745361', 'type': 'BACKGROUND', 'citation': 'Rota E, Evangelista A, Ceccarelli M, Ferrero L, Milani C, Ugolini A, Mongini F. Efficacy of a workplace relaxation exercise program on muscle tenderness in a working community with headache and neck pain: a longitudinal, controlled study. Eur J Phys Rehabil Med. 2016 Aug;52(4):457-65. Epub 2016 Jan 8.'}, {'pmid': '33139645', 'type': 'BACKGROUND', 'citation': 'Lee BK, Seo DK. The Importance of Optimal Gaze Direction on Deep Neck Flexor Activation in Chronic Neck Pain. Healthcare (Basel). 2020 Nov 1;8(4):449. doi: 10.3390/healthcare8040449.'}, {'pmid': '34980079', 'type': 'BACKGROUND', 'citation': 'Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.'}, {'pmid': '19632880', 'type': 'BACKGROUND', 'citation': 'Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine whether relaxation exercises performed before cranio-cervical flexion can reduce superficial neck muscle activation (specifically sternocleidomastoid and upper trapezius) in individuals with neck pain.\n\nThe main questions it aims to answer are:\n\n* Does performing relaxation exercises prior to cranio-cervical flexion reduce sternocleidomastoid (SCM) muscle activation?\n* Does it reduce upper trapezius muscle activation during the standing?\n\nResearchers will compare the group performing relaxation exercises before cranio-cervical flexion to the group performing only cranio-cervical flexion to see if there is a measurable difference in superficial neck muscle activation.\n\nParticipants will:\n\n* Perform cranio-cervical flexion exercises.\n* Perform relaxation exercises prior to the cranio-cervical flexion (intervention group only).\n* Undergo surface EMG measurements to assess muscle activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knowledge of Turkish\n* Chronic (at least three months) neck pain\n* Neck pain level of 4 or higher on a numerical pain scale\n\nExclusion Criteria:\n\n* Neck pain caused by a tumor, trauma, or rheumatic disease\n* History of surgery involving the head, neck, shoulder, or thoracic region\n* Root compression\n* Regular use of painkillers due to another illness\n* Another illness severe enough to interfere with work'}, 'identificationModule': {'nctId': 'NCT07048093', 'briefTitle': 'Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Development of Standard Guidelines for Relaxation Exercises in Patients With Chronic Neck Pain and Determination of Their Effectiveness', 'orgStudyIdInfo': {'id': 'G.O. 2024/153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relaxation Exercises Group', 'description': 'This group will do relaxation exercises based on reciprocal inhibition, autogenic inhibition, proprioceptive training and postural training.', 'interventionNames': ['Other: Exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Just Lie Back Group', 'description': 'This group do nothing but just lie back before and after actual measurements.', 'interventionNames': ['Other: Sham (No Treatment)']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Average of 10 minutes relaxation exercises guided with a standard audio record based on reciprocal and autogenic muscle inhibition, proprioceptive training and postural training.', 'armGroupLabels': ['Relaxation Exercises Group']}, {'name': 'Sham (No Treatment)', 'type': 'OTHER', 'description': 'This group take no treatment between actual before and after measurements.', 'armGroupLabels': ['Just Lie Back Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10145', 'city': 'Balıkesir', 'state': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sibel Ergun, Professor', 'role': 'CONTACT', 'email': 'sibel.ergun@balikesir.edu.tr', 'phone': '+902666121400', 'phoneExt': '151330'}, {'name': 'Meral Sertel, Professor', 'role': 'CONTACT', 'email': 'meral.sertel@balikesir.edu.tr', 'phone': '+902666121400', 'phoneExt': '151318'}], 'facility': 'Faculty of Health Sciences', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'centralContacts': [{'name': 'Utku Berberoğlu, PhD', 'role': 'CONTACT', 'email': 'utku.berber@gmail.com', 'phone': '+902666121400', 'phoneExt': '151315'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This ethics committee has not yet established a data policy regarding open data. Otherwise, I would share it once it has been anonymised. I am still discussing this matter with the committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Proffesor', 'investigatorFullName': 'Utku Berberoğlu', 'investigatorAffiliation': 'Balikesir University'}}}}