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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.
The main questions it aims to answer are:
Researchers will compare three groups to see if the delivery model affects outcomes:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time Video-Guided Neck Exercises (Tele-rehabilitation) | Experimental | 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. |
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| In-Person Supervised Neck Exercises (Face-to-Face) | Experimental | 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. |
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| Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation) | Other | Intervention 1: Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation) How the Intervention is Administered: Delivery Method: Real-time video conferencing App Frequency: 3 sessions per week Duration: 6 weeks (18 total sessions) Session Length: 45-60 minutes per session Supervision: Live physiotherapist supervision with real-time feedback and exercise modification Setting: Participant's home or preferred location with stable internet connection Materials Provided: Illustrated exercise guide (provided digitally and in print) Access to video conferences for sessions Optional: Resistance bands for home use |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability | 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. | • 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) |
| Neck Pain Intensity | 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. | • 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 |
| Range of motion | 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. | • 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinesiophobia | 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 | • 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) |
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Inclusion Criteria
Patients will be included in the study if they fulfil the following criteria:
Exclusion Criteria
Patients will be excluded if they had:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr Ahmad Fallatah, Doctoral | Contact | 00966505536390 | aam_fallatah@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mona Mohamed Ibrahim, Assistant Professor | Cairo University | Principal Investigator |
| Moaaz Ragab Riyad, Lecturer of Physical therapy | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28241215 | Background | 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. | |
| 37770963 |
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| In-Person Supervised Neck Exercises (Face-to-Face) | Other | How the Intervention is Administered: Delivery Method: In-person supervised sessions at clinical facility Frequency: 3 sessions per week Duration: 6 weeks (18 total sessions) Session Length: 45-60 minutes per session Supervision: Direct physiotherapist supervision with hands-on guidance and real-time feedback Setting: Clinical rehabilitation facility |
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| Hybrid Tele-Rehabilitation and In-Person Exercises (Mixed Model) | Other | How the Intervention is Administered: Delivery Method: Alternating weekly blocks of tele-rehabilitation (video conferencing and face-to-face sessions Frequency: 3 sessions per week (alternating delivery) Duration: 6 weeks (18 total sessions: 9 tele-rehabilitation + 9 face-to-face) Session Length: 45-60 minutes per session Supervision: Live physiotherapist supervision for both modalities Setting: Mixed (participant's home for tele-rehabilitation weeks; clinical facility for face-to-face weeks) Weekly Schedule: • Weeks 1, 3, 5: Three face-to-face sessions per week at clinical facility • Weeks 2, 4, 6: Three tele-rehabilitation sessions per week via Microsoft Teams Materials Provided: • Illustrated exercise guide (provided in both digital and print formats) • Access to video conferencing App for tele-rehabilitation sessions • Access to clinical facility equipment during face-to-face weeks • Optional: Resistance bands for home use during tele-rehabilitation week |
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| Patient Satisfaction | 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. | • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) |
| Adherence to Treatment | 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). | • 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) |
| 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. |
| 20436238 | Background | 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. |
| Background | Antonio, G. L., Almeida, M. Q., Vera, M. A., de Noronha, M. A., & Selistre, L. F. (2024). Efficacy of telerehabilitation exercise in patients with chronic neck pain: A protocol for a randomized controlled trial. Brazilian Journal of Physical Therapy, 28, 100748. DOI: 10.1016/j.bjpt.2024.100748 |
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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