Deep Cervical Flexor and Sensorimotor Training for Chronic Neck Pain

NCT ID: NCT07040605

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-19
• Study Completion Date: 2025-12-31

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.

Detailed Description

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. All participants will attend three supervised sessions per week, with each session lasting approximately 45-60 minutes. 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.

In addition, 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. Head relocation exercises will be conducted using a laser pointer attached to a helmet, with participants practicing relocating their head to a neutral position or predetermined positions, initially with eyes open using visual feedback and later progressing to eyes closed. Oculomotor exercises will begin with eye movements while keeping the head stationary, progressing to combined head and eye movements following visual targets. Eye-head coordination exercises will involve moving the eyes and head to the same side, followed by movements where the eyes lead and the head follows, and eventually progressing to eyes and head moving in opposite directions. Exercises will be progressed by increasing speed, range, and target difficulty. This proprioceptive training will also be performed three times per week for four weeks.

The control group will receive the conventional physical therapy program alone, without the additional deep cervical flexor or proprioception training components. Outcome measures for both groups will be assessed at baseline and after four weeks, including pain intensity using the Numeric Pain Rating Scale (NPRS), craniovertebral angle measured by the APECS mobile application, cervical range of motion via Digital Inclinometer, Segmental mobility using spinal mouse, neuromotor control using the Craniocervical Flexion Test with a pressure biofeedback unit, proprioception assessed through head repositioning accuracy tests, and respiratory function parameters (FEV1 and peak expiratory flow) measured with the spirometer.

Conditions

Mechanical Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

core stability exercise and proprioception training

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.

Group Type: EXPERIMENTAL

Deep cervical flexors muscle training and sensorimotor training

Intervention Type: OTHER

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.

conventional physical therapy exercise

. 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.

Group Type: ACTIVE_COMPARATOR

conventional physical therapy exercise

Intervention Type: OTHER

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.

Interventions

Deep cervical flexors muscle training and sensorimotor training

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.

Intervention Type: OTHER

conventional physical therapy exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Neelain University

OTHER

Sponsor Role: lead

Responsible Party

Halla Taj Elsir Ahmed

lecturer of orthopaedic physical therapy, faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled A Ayad, Professor

Role: STUDY_CHAIR

Cairo University

Karima A Mohamed, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Out-patient clinic- Faculty of physical therapy

Cairo, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Halla T Ahmed, MSc

Role: CONTACT

htajelsir@ju.edu.sa

+966545277073

Karima A Mohamed, PhD

Role: CONTACT

karima_hassan2008@yahoo.com

+201114032967

Facility Contacts

Karima A Mohamed, PhD

Role: primary

karima_hassan2008@yahoo.com

+201114032967

Other Identifiers

P.T.REC/012/005888

Identifier Type: -

Identifier Source: org_study_id