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

Обзор

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.

Вмешательства

• Другое 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 exerci
• Другое 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
• Другое 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 wee

Первичные конечные точки

• Functional Disability [Срок оценки: • 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 [Срок оценки: • 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 [Срок оценки: • 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.]

Вторичные конечные точки (3)

• Kinesiophobia [Срок оценки: • 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)]
• Patient Satisfaction [Срок оценки: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session)]
• Adherence to Treatment [Срок оценки: • 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)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy, Cairo University — Cairo

Публикации

• 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. PMID 28241215
• 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. PMID 37770963
• 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. PMID 20436238
• 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

Идентификаторы

NCT: NCT07302958 · TR,Face to Face, mix model NP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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