NCT07040605

Brief Summary

This randomized controlled trial aims to investigate the effectiveness of deep cervical flexor muscle training combined with sensorimotor (proprioception) training in patients with chronic mechanical neck pain. The study will be conducted in outpatient clinic of the faculty of physical therapy- Cairo University, involving 60 participants aged 20-40 years with neck pain persisting for more than three months. Participants will be randomly allocated into an experimental group receiving conventional physical therapy plus deep flexor and sensorimotor training, and a control group receiving conventional treatment alone. Outcome measures will include pain intensity, craniovertebral angle (CVA), cervical range of motion (ROM), segmental mobility, neuromotor control, proprioception (head repositioning accuracy), and respiratory function (FEV1 and PEF). Assessments will be performed at baseline and after four weeks of intervention. The study seeks to provide evidence-based recommendations for physiotherapy management of mechanical neck pain, particularly addressing the gaps in literature within the regional context.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

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

First Submitted

Initial submission to the registry

June 19, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 19, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

mechanical neck painsensorimotor trainingDeep cervical flexors muscles

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity Score on the Numeric Pain Rating Scale (NPRS) from Baseline to 4 Weeks

    which will be measured using the Numeric Pain Rating Scale (NPRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

    4 weeks

Secondary Outcomes (5)

  • Change in Cervical Range of Motion (ROM) in Degrees Measured by Digital Inclinometer from Baseline to 4 Weeks

    4 weeks

  • Change in Neuromotor Control of the Deep Cervical Flexor Muscles Assessed by Craniocervical Flexion Test (CCFT) from Baseline to 4 Weeks

    4 weeks

  • Change in Craniovertebral Angle (CVA) Measured by AI Posture Evaluation and Correction System (APECS) from Baseline to 4 Weeks

    4 weeks

  • Change in Cervical Proprioceptive Function Assessed by Head Repositioning Accuracy (HRA) Test in centimetre from Baseline to 4 Weeks

    4 weeks

  • Change in Respiratory Function Parameters (FEV1 and PEF) Measured by Spirometer from Baseline to 4 Weeks

    4 weeks

Study Arms (2)

core stability exercise and proprioception training

EXPERIMENTAL

Participants in the experimental group will receive a structured four-week physiotherapy intervention consisting of conventional physical therapy treatment combined with deep cervical flexor muscle training and proprioception (sensorimotor) training.

Other: Deep cervical flexors muscle training and sensorimotor training

conventional physical therapy exercise

ACTIVE COMPARATOR

. Conventional physiotherapy will include stretching exercises targeting the sternocleidomastoid, upper trapezius, levator scapulae, scalene, Rhomboids and pectoralis muscles, performed in three repetitions, holding each stretch for thirty seconds, strengthening exercises will be provided Isometrically for the cervical flexors, extensors and at sides using a prescription of three sets of ten repetitions with a ten-second hold and two minutes of rest between sets. TENS for 15 min. hot back for 15 min.

Other: conventional physical therapy exercise

Interventions

deep cervical flexor muscle training will be performed according to the protocol of Jull and Falla using a pressure biofeedback unit. Participants will be positioned in a supine crook-lying posture with the neck in a neutral position, and the air bag of the pressure biofeedback unit will be placed beneath the cervical lordosis and inflated to a baseline of 20 mmHg. Patients will be instructed to perform a gentle nodding action, increasing the pressure by 2 mmHg increments up to 30 mmHg. Each increment will be held for ten seconds, repeated in three sets of ten repetitions, with a two-minute rest between sets. To enhance activation of the deep flexors, patients will be instructed to keep their mouth open during the exercise. Proprioception training will include head relocation practice, oculomotor exercises, and eye-head coordination exercises.

core stability exercise and proprioception training

will include stretching exercises targeting the sternocleidomastoid, upper trapezius, levator scapulae, scalene, Rhomboids and pectoralis muscles, performed in three repetitions, holding each stretch for thirty seconds, strengthening exercises will be provided Isometrically for the cervical flexors, extensors and at sides using a prescription of three sets of ten repetitions with a ten-second hold and two minutes of rest between sets. TENS and Hot back.

conventional physical therapy exercise

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants aged between 20-40 years.
  • participant having neck pain report more than 4 in NPRS, and at least within the last three months known as chronic pain.
  • participant with CVA more than 45 degrees and less than 50.
  • Participant with poor cervical muscle endurance.

You may not qualify if:

  • Participant with acute neck pain (less than three month).
  • Participant with radiated neck pain.
  • Participant who undergone recent surgeries within the thoracic, shoulder girdle, and cervical spine regions.
  • Participants who were already undergoing treatment for neck pain.
  • Participant with fixed spinal deformity.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Out-patient clinic- Faculty of physical therapy

Cairo, Giza Governorate, 12111, Egypt

RECRUITING

Study Officials

  • Khaled A Ayad, Professor

    Cairo University

    STUDY CHAIR
  • Karima A Mohamed, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Halla T Ahmed, MSc

CONTACT

Karima A Mohamed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of orthopaedic physical therapy, faculty of physical therapy

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 27, 2025

Study Start

June 19, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

study result

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 months after publication
Access Criteria
study protocol

Locations