Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation)

    Other intervention

    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

  • In-Person Supervised Neck Exercises (Face-to-Face)

    Other intervention

    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

  • Hybrid Tele-Rehabilitation and In-Person Exercises (Mixed Model)

    Other intervention

    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

Treatment groups

68 Participants
are divided into 3 treatment groups
Group A: Real-time Video-Guided Neck Exercises (Tele-rehabilitation)Experimental treatment 1 intervention
Group B: In-Person Supervised Neck Exercises (Face-to-Face)Experimental treatment 1 intervention
Group C: Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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)
2

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.

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
3

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.

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.

Secondary outcomes

1

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

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)
2

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.

Time frame
• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)
3

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).

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)

Other outcomes

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