Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT07302958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Disability', 'timeFrame': '• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention)', 'description': "The Neck Disability Index is the most widely used and validated instrument for assessing the impact of neck pain on patients' functional activities and disability. The NDI-AR consists of 10 items covering functional domains: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (complete disability), with a maximum total score of 50."}, {'measure': 'Neck Pain Intensity', 'timeFrame': '• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention', 'description': 'The Visual Analogue scale is a self-reported, unidimensional measure of pain intensity. Participants mark their current pain level on a 10-centimeter line, where 0 represents "no pain" and 10 represents "worst pain imaginable.'}, {'measure': 'Range of motion', 'timeFrame': '• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention.', 'description': 'The CROM device is a non-invasive, objective measurement tool designed specifically for assessing cervical spine mobility. The device measures cervical motion in six planes: flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation. Measurements are recorded in degrees.'}], 'secondaryOutcomes': [{'measure': 'Kinesiophobia', 'timeFrame': '• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention)', 'description': 'The Tampa Scale of Kinesiophobia is a 17-item self-report questionnaire designed to assess the fear of \\[re\\]injury associated with physical movement. Respondents rate each item on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score ranges from 17 to 68, with higher scores indicating greater fear of movement and \\[re\\]injury'}, {'measure': 'Patient Satisfaction', 'timeFrame': '• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)', 'description': 'The Patient Satisfaction Questionnaire (PSQ-18) is a validated short-form instrument originally developed by the RAND Corporation to measure patient satisfaction with medical care. The PSQ-18 is an 18-item version that retains the essential psychometric qualities of the full-length PSQ-III while providing a practical and comprehensive assessment.'}, {'measure': 'Adherence to Treatment', 'timeFrame': '• Throughout the 6-week intervention period (Weeks 1-6, continuous tracking at each session) • Final adherence rate calculated within 1 week post-treatment (Week 6, at completion of intervention)', 'description': 'Adherence to treatment is assessed through systematic attendance tracking and session completion records. An attendance sheet is used to register participant attendance at each session with the date and session number. Adherence is calculated as the percentage of completed sessions relative to the total number of prescribed sessions (18 sessions over 6 weeks).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telerehabilitation', 'Chronic Non specific Neck pain', 'Face to face physiotherapy'], 'conditions': ['Chronic Non-specific Neck Pain']}, 'referencesModule': {'references': [{'pmid': '28241215', 'type': 'BACKGROUND', 'citation': 'Bennell KL, Nelligan R, Dobson F, Rini C, Keefe F, Kasza J, French S, Bryant C, Dalwood A, Abbott JH, Hinman RS. Effectiveness of an Internet-Delivered Exercise and Pain-Coping Skills Training Intervention for Persons With Chronic Knee Pain: A Randomized Trial. Ann Intern Med. 2017 Apr 4;166(7):453-462. doi: 10.7326/M16-1714. Epub 2017 Feb 21.'}, {'pmid': '37770963', 'type': 'BACKGROUND', 'citation': 'Barbosa JC, Comachio J, Marques AP, Saragiotto BT, Magalhaes MO. Effect of a telerehabilitation exercise program versus a digital booklet with self-care for patients with chronic non-specific neck pain: a protocol of a randomized controlled trial assessor-blinded, 3 months follow-up. Trials. 2023 Sep 28;24(1):616. doi: 10.1186/s13063-023-07651-z.'}, {'pmid': '20436238', 'type': 'BACKGROUND', 'citation': 'Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.'}, {'pmid': '37850374', 'type': 'BACKGROUND', 'citation': 'Neves Antonio GL, Almeida MQ, Avila MA, de Noronha MA, Approbato Selistre LF. Efficacy of telerehabilitation exercise in patients with chronic neck pain: a protocol for a non-inferiority randomized controlled trial. Pain Manag. 2023 Sep;13(9):497-507. doi: 10.2217/pmt-2023-0070. Epub 2023 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness of different physical therapy delivery models in treating chronic non-specific neck pain in adults aged 20-40 years with a history of neck pain for three months or longer.\n\nThe main questions it aims to answer are:\n\n* Which approach (tele-rehabilitation, face-to-face exercises, or a mixed model) is most effective at reducing neck pain intensity and functional disability?\n* Are there significant differences between the three models in improving cervical range of motion, kinesiophobia (fear of movement), patient satisfaction, and adherence to the exercise program?\n\nResearchers will compare three groups to see if the delivery model affects outcomes:\n\n1. A tele-rehabilitation group receiving real-time, video-guided exercise sessions.\n2. A face-to-face group receiving traditional, in-person supervised exercise sessions.\n3. A mixed-model group receiving a combination of both tele-rehabilitation and face-to-face sessions.\n\nParticipants will:\n\n* Be randomly assigned to one of the three groups.\n* Engage in a structured exercise program for 45-60 minutes per session, three times a week for six weeks.\n* Follow a phased exercise protocol that begins with mobility and pain reduction, progresses to strengthening, and finishes with endurance and functional training.\n* Complete assessments for pain, disability, range of motion, and other outcomes at the beginning and end of the 6-week intervention, with a final follow-up at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients will be included in the study if they fulfil the following criteria:\n\n* Adults (20-40 years) with chronic non-specific neck pain (≥3 months' duration).\n* Participants with stable internet, and experienced in using either computer, laptop, tablet, or smartphone.\n\nExclusion Criteria\n\nPatients will be excluded if they had:\n\n1. Neck pain due to specific pathologies (e.g., fractures, infections, or malignancies) and severe neurological deficits.\n2. History of neck surgery.\n3. Participants with cognitive impairments or language barriers that would prevent them from following the interventions."}, 'identificationModule': {'nctId': 'NCT07302958', 'acronym': 'TR Neck pain', 'briefTitle': 'Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain', 'orgStudyIdInfo': {'id': 'TR,Face to Face, mix model NP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real-time Video-Guided Neck Exercises (Tele-rehabilitation)', 'description': 'Participants in this arm receive real-time, synchronous tele-rehabilitation sessions delivered via Microsoft Teams video conferencing platform. A licensed physiotherapist provides live supervision, real-time feedback, and technique correction throughout each session. This arm tests the effectiveness of remote delivery of structured neck exercises with synchronous clinician guidance.', 'interventionNames': ['Other: Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation)']}, {'type': 'EXPERIMENTAL', 'label': 'In-Person Supervised Neck Exercises (Face-to-Face)', 'description': 'Participants in this arm receive traditional, in-person supervised exercise sessions at a clinical facility. A licensed physiotherapist provides hands-on guidance, manual corrections, and real-time feedback during each session. This arm serves as the standard care comparison and tests the effectiveness of conventional face-to-face delivery.', 'interventionNames': ['Other: In-Person Supervised Neck Exercises (Face-to-Face)']}, {'type': 'EXPERIMENTAL', 'label': 'Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)', 'description': 'Participants in this arm receive a novel 50/50 hybrid intervention combining equal proportions of tele-rehabilitation and face-to-face sessions delivered in alternating weekly blocks. Weeks with odd numbers (1, 3, 5) consist of three in-person face-to-face sessions, while weeks with even numbers (2, 4, 6) consist of three tele-rehabilitation sessions. This arm tests whether a hybrid approach optimizes accessibility, adherence, and clinical outcomes by combining the convenience of remote delivery with the benefits of in-person supervision.', 'interventionNames': ['Other: Hybrid Tele-Rehabilitation and In-Person Exercises (Mixed Model)']}], 'interventions': [{'name': 'Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation)', 'type': 'OTHER', 'description': "Intervention 1: Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation)\n\nHow the Intervention is Administered:\n\nDelivery Method: Real-time video conferencing App\n\nFrequency: 3 sessions per week\n\nDuration: 6 weeks (18 total sessions)\n\nSession Length: 45-60 minutes per session\n\nSupervision: Live physiotherapist supervision with real-time feedback and exercise modification\n\nSetting: Participant's home or preferred location with stable internet connection\n\nMaterials Provided:\n\nIllustrated exercise guide (provided digitally and in print)\n\nAccess to video conferences for sessions\n\nOptional: Resistance bands for home use", 'armGroupLabels': ['Real-time Video-Guided Neck Exercises (Tele-rehabilitation)']}, {'name': 'In-Person Supervised Neck Exercises (Face-to-Face)', 'type': 'OTHER', 'description': 'How the Intervention is Administered:\n\nDelivery Method: In-person supervised sessions at clinical facility\n\nFrequency: 3 sessions per week\n\nDuration: 6 weeks (18 total sessions)\n\nSession Length: 45-60 minutes per session\n\nSupervision: Direct physiotherapist supervision with hands-on guidance and real-time feedback\n\nSetting: Clinical rehabilitation facility', 'armGroupLabels': ['In-Person Supervised Neck Exercises (Face-to-Face)']}, {'name': 'Hybrid Tele-Rehabilitation and In-Person Exercises (Mixed Model)', 'type': 'OTHER', 'description': "How the Intervention is Administered:\n\nDelivery Method: Alternating weekly blocks of tele-rehabilitation (video conferencing and face-to-face sessions\n\nFrequency: 3 sessions per week (alternating delivery)\n\nDuration: 6 weeks (18 total sessions: 9 tele-rehabilitation + 9 face-to-face)\n\nSession Length: 45-60 minutes per session\n\nSupervision: Live physiotherapist supervision for both modalities\n\nSetting: Mixed (participant's home for tele-rehabilitation weeks; clinical facility for face-to-face weeks)\n\nWeekly Schedule:\n\n• Weeks 1, 3, 5: Three face-to-face sessions per week at clinical facility\n\n• Weeks 2, 4, 6: Three tele-rehabilitation sessions per week via Microsoft Teams\n\nMaterials Provided:\n\n• Illustrated exercise guide (provided in both digital and print formats)\n\n• Access to video conferencing App for tele-rehabilitation sessions\n\n• Access to clinical facility equipment during face-to-face weeks\n\n• Optional: Resistance bands for home use during tele-rehabilitation week", 'armGroupLabels': ['Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Amr Ahmad Fallatah, Doctoral', 'role': 'CONTACT', 'email': 'aam_fallatah@hotmail.com', 'phone': '00966505536390'}, {'name': 'Mona Mohamed Ibrahim, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Moaaz Ragab Riyad, Lecturer', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Physical Therapy, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr Ahmad Fallatah, Doctoral', 'role': 'CONTACT', 'email': 'aam_fallatah@hotmail.com', 'phone': '00966505536390'}], 'overallOfficials': [{'name': 'Mona Mohamed Ibrahim, Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Moaaz Ragab Riyad, Lecturer of Physical therapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Amr', 'investigatorFullName': 'Amr Ahmad Fallatah', 'investigatorAffiliation': 'Cairo University'}}}}