NCT Number: NCT07302958
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:
1. A tele-rehabilitation group receiving real-time, video-guided exercise sessions. 2. A face-to-face group receiving traditional, in-person supervised exercise sessions. 3. 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.
Interested in participating?
Request Info20 year–45 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Amr Ahmad Fallatah, Doctoral
CONTACT
Moaaz Ragab Riyad, Lecturer
SUB_INVESTIGATOR
Mona Mohamed Ibrahim, Assistant Professor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be included in the study if they fulfil the following criteria:
Exclusion criteria
Patients will be excluded if they had:
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
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
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:
Materials Provided:
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)
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.
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
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.
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.
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.
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)
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
Time frame: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)
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.
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)
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).
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Acronym: TR Neck pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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