NCT07606729

Brief Summary

Non-specific chronic neck pain represents a major global health burden, affecting 30% to 50% of the general population. It is particularly prevalent among office workers, computer users, and women, with a notable rise in young adults aged 20 to 24. While acute episodes of neck pain may initially resolve, underlying functional impairments often persist, causing over a third of patients to develop chronic symptoms lasting three months or longer. Typically localized in the lateral and posterior neck regions without radicular signs, this condition is frequently driven by poor posture and improper ergonomics. The resulting abnormal stress on the cervical spine and musculature severely limits daily activities, lowers overall quality of life, and places a heavy socioeconomic strain on patients and their communities. Traditional conservative management typically relies on a combination of pharmacotherapy and standard physical therapy modalities, including manual techniques, exercise programs, electrotherapy, and thermal agents. However, these conventional interventions demand frequent, in-person clinical visits, creating a significant financial and logistical barrier for many families, particularly under current economic challenges in Egypt. Consequently, there is an urgent need for cost-effective, highly accessible, and novel rehabilitation models that can streamline care and optimize clinical outcomes. Artificial intelligence (AI) and machine learning offer a promising solution to these challenges by providing automated, data-driven remote care. Through mobile apps and smart rehabilitation platforms, AI can analyze complex clinical datasets-including patient demographics, pain intensity, and radiographic alignment-to predict treatment timelines and automate routine clinical tasks. Crucially, AI solves the problem of standardized, non-individualized home exercise plans by adjusting to a patient's daily symptom presentation, mimics a therapist's tailored approach, and offers real-time feedback. However, as these technologies advance, a clear gap remains in the physical therapy profession. Many clinicians lack a foundational understanding of AI fundamentals and harbor concerns about automation, highlighting an urgent need to evaluate physical therapists' perceptions and preparation to foster clinical trust and seamless integration.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

NON-SPECIFIC CHRONIC NECK PAINTRADITIONAL PHYSICAL THERAPYAI-DRIVEN PROGRAM

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    For evaluating the pain degree of severity, the visual analogue scale was employed. It is a 10 cm or 100 mm psychometric response scale to measure pain intensity based on numerical values, anchored by a score of 0 no pain and score 10 worst ever pain.

    up to 6 weeks

  • Cervical Range of Motion

    Cervical Range of Motion (CROM) device is a clinical tool commonly used to measure cervical ROM. The CROM device utilizes three inclinometers to measure active mobility of the cervical spine. Many studies have reported strong validity and reliability of the CROM device supporting the clinical value of the instrument. It was shown to have moderate to good intra-rater and inter-rater reliability of 0.84 to 0.96 and 0.73 to 0.94, respectively.

    up to 6 weeks

  • Cervical Proprioception

    The Cervical Range of Motion (CROM) device also used to measure proprioception.Cervical proprioception was assessed by determining joint position error (JPE). JPE can be used to measure the ability of the individual to reposition their head back to its neutral head position (NHP) or to a predefined target head position (THP).

    up to 6 weeks

Secondary Outcomes (1)

  • Neck Disability Index

    up to 6 weeks

Study Arms (2)

AI-Driven Program

EXPERIMENTAL

Week 1 Hot pack / warm shower Chin to chest Gaze to ceiling Head rotation Shoulder rolls Cranio-cervical flexion (CCF) with pressure biofeedback Wall scapular clocks Week 2 Hot pack / warm shower Cat-cow exercise Thread-the-needle stretch Cranio-cervical flexion (CCF) with pressure biofeedback Theraband rows Serratus wall slides Week 3 Thoracic extension on foam roller Cranio-cervical flexion (CCF) with pressure biofeedback Theraband rows Prone T exercise Week 4 Dynamic pectoral corner stretch Cranio-cervical flexion (CCF) with pressure biofeedback Supine serratus punch Week 5 Prone chin tuck Serratus punch Prone Y exercise Week 6 Cranio-cervical flexion (CCF) with pressure biofeedback Band external rotation Theraband rows

Device: Pressure Biobfeedback

Traditional Physical Therapy Program

EXPERIMENTAL

This Group Will receive neck ROM exercises including: (neck extension, flexion, rotation, lateral bending motions, and scapular retraction, with no resistance), conventional physical therapy including: (Isometric training exercises for neck flexors, extensors, lateral flexors and rotators, Passive stretching exercises for neck extensor muscles, neck lateral flexor muscles, and scalene muscle, Hot packs), Dynamic pec stretch, Chin in exercise, core stabilization exercise including Bridging exercise and Quadruped with leg extension exercise.

Device: Hot Pack

Interventions

Pressure biofeedback is a noninvasive technique that provides knowledge of performance through the hand held apparatus that can augment the patient's sensory feedback mechanism. In clinical practice, pressure biofeedback devices have primarily been used to test and train the deep neck flexor muscles to improve endurance

AI-Driven Program
Hot PackDEVICE

used for warming up before exercises

Traditional Physical Therapy Program

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients were selected according to the following criteria:
  • Forty subjects who have complained of Nonspecific chronic Neck pain diagnosed by a physician will be recruited from the outpatient clinics through direct referrals, Faculty of Physical Therapy, Misr University for Science and Technology.
  • Having neck pain for at least three months.
  • Age: between 18-35 years old
  • Both genders (Males and Females).
  • Normal body mass index BMI (18.5-24.9)

You may not qualify if:

  • A history of cervical spine injury or surgery.
  • Neck pain as secondary to other conditions including neoplasm, neurological diseases or vascular diseases.
  • Radiculopathy with neurological deficits.
  • A history of infection or inflammatory arthritis in the cervical spine.
  • Physical therapy within last six months.
  • Presence of pain in the shoulder, upper extremity, scapula, or cervical spine that prohibited exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariam

Giza, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

January 10, 2026

Primary Completion

April 10, 2026

Study Completion

May 19, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations