- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302958
Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain (TR Neck pain)
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:
- Which approach (tele-rehabilitation, face-to-face exercises, or a mixed model) is most effective at reducing neck pain intensity and functional disability?
- 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?
Researchers will compare three groups to see if the delivery model affects outcomes:
- A tele-rehabilitation group receiving real-time, video-guided exercise sessions.
- A face-to-face group receiving traditional, in-person supervised exercise sessions.
- A mixed-model group receiving a combination of both tele-rehabilitation and face-to-face sessions.
Participants will:
- Be randomly assigned to one of the three groups.
- Engage in a structured exercise program for 45-60 minutes per session, three times a week for six weeks.
- Follow a phased exercise protocol that begins with mobility and pain reduction, progresses to strengthening, and finishes with endurance and functional training.
- 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amr Ahmad Fallatah, Doctoral
- Phone Number: 00966505536390
- Email: aam_fallatah@hotmail.com
Study Locations
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Cairo, Egypt
- Recruiting
- Faculty of physical therapy, Cairo University
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Contact:
- Amr Ahmad Fallatah, Doctoral
- Phone Number: 00966505536390
- Email: aam_fallatah@hotmail.com
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Principal Investigator:
- Mona Mohamed Ibrahim, Assistant Professor
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Sub-Investigator:
- Moaaz Ragab Riyad, Lecturer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Patients will be included in the study if they fulfil the following criteria:
- Adults (20-40 years) with chronic non-specific neck pain (≥3 months' duration).
- Participants with stable internet, and experienced in using either computer, laptop, tablet, or smartphone.
Exclusion Criteria
Patients will be excluded if they had:
- Neck pain due to specific pathologies (e.g., fractures, infections, or malignancies) and severe neurological deficits.
- History of neck surgery.
- Participants with cognitive impairments or language barriers that would prevent them from following the interventions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Real-time Video-Guided Neck Exercises (Tele-rehabilitation)
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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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 |
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Experimental: In-Person Supervised Neck Exercises (Face-to-Face)
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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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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Experimental: Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)
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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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Disability
Time Frame: • 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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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.
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• 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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Neck Pain Intensity
Time Frame: • 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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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.
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• 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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Range of motion
Time Frame: • 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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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.
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• 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: • 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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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
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• 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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Patient Satisfaction
Time Frame: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)
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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.
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• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)
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Adherence to Treatment
Time Frame: • 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)
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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).
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• 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)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona Mohamed Ibrahim, Assistant Professor, Cairo University
- Principal Investigator: Moaaz Ragab Riyad, Lecturer of Physical therapy, Cairo University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR,Face to Face, mix model NP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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