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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Functional Disability — • 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.
• Neck Pain Intensity — • 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.
• Range of motion — • 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.

Trial sites (1)

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