NCT07302958

Brief 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:
  • 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.
  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

December 8, 2025

Last Update Submit

February 27, 2026

Conditions

Keywords

TelerehabilitationChronic Non specific Neck painFace to face physiotherapy

Outcome Measures

Primary Outcomes (3)

  • 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.

    • 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

    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.

    • 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

    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.

    • 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 (3)

  • Kinesiophobia

    • 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

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

  • Adherence to Treatment

    • 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)

Study Arms (3)

Real-time Video-Guided Neck Exercises (Tele-rehabilitation)

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

Other: In-Person Supervised Neck Exercises (Face-to-Face)

Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)

EXPERIMENTAL

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.

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

Interventions

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

Real-time Video-Guided Neck Exercises (Tele-rehabilitation)

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

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

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

Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (4)

  • 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: 28241215BACKGROUND
  • 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: 37770963BACKGROUND
  • 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: 20436238BACKGROUND
  • 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.

    PMID: 37850374BACKGROUND

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mona Mohamed Ibrahim, Assistant Professor

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Moaaz Ragab Riyad, Lecturer of Physical therapy

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Ahmad Fallatah, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Amr

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 24, 2025

Study Start

February 24, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations