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NCT Number: NCT07814833

Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis

This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis. The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hope Physiotherapy Clinic

Rawalpindi, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Nida Khan

CONTACT

[email protected]

0331-0404000

About this study

Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up.

Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy.

Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders aged 40-60 years.
  • Presence of chronic neck pain for ≥3 months with NPRS ≥3.
  • Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
  • Ability to perform active cervical and shoulder movements without neurological deficits.
  • Willingness to participate in the study and comply with the intervention protocol.

Exclusion criteria

  • History of cervical spine surgery or trauma in the past 6 months.
  • Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
  • Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
  • Current participation in structured neck/shoulder rehabilitation programs.
  • Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.

Treatment and study plan

Pressure Biofeedback-Assisted Deep Cervical Flexor Training

Other

Deep cervical flexor training will be performed using a pressure biofeedback unit to facilitate selective activation and improve the strength and endurance of the deep cervical flexor muscles, particularly the longus colli and longus capitis. The participant will be positioned in supine lying with the hips and knees comfortably flexed, and the pressure biofeedback cuff will be placed beneath the cervical spine at approximately the C4-C5 level. The cuff will be inflated to a baseline pressure of 20 mmHg. The participant will be instructed to perform a gentle cranio-cervical flexion movement by slowly nodding the head and drawing the chin inward while maintaining contact of the head with the treatment surface. The pressure will be gradually increased to the prescribed target while avoiding head lifting, excessive cervical flexion, jaw clenching, shoulder elevation, or compensatory activation of the superficial cervical muscles. The target pressure will be 22 mmHg during the first week, 2

Scapular stabilization exercises

Other

Scapular stabilization exercises will be performed progressively to improve scapular control, postural alignment, and the strength and endurance of the scapular stabilizing muscles. During the first week, scapular retraction and depression exercises will be performed in sitting for 3 sets of 10 repetitions with a 5-second hold and 60 seconds rest between sets. During the second week, scapular retraction will be progressed using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement and 60 seconds rest between sets. During the third week, wall slides and prone Y and T raises will be introduced and performed for 3 sets of 8-10 repetitions with controlled movement and 30-60 seconds rest between sets. During the fourth week, scapular stabilization exercises will be progressed with shoulder flexion and abduction while maintaining appropriate scapular control, performed for 3 sets of 10 repetitions with 30-60 seconds rest between sets. All exercises will be performe

Standard Physiotherapy

Other

Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance. Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction. Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions. Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions. Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures. Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.

Primary outcomes

  1. Neck Disability - Neck Disability Index (NDI)

    Time frame: Baseline and after 4 weeks of treatment.

    Measure: Functional disability related to neck pain measured using the Neck Disability Index.

  2. Pain Intensity - Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline and after 4 weeks of treatment

    Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale

  3. Universal Goniometer

    Time frame: Baseline and after 4 weeks of treatment.

    Measure Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion and right/left rotation

Secondary outcomes

  1. The Neck Flexor Endurance Test

    Time frame: Baseline and after 4 weeks of treatment

    Measure cervical flexor muscle endurance

Study contacts

Contact information is provided by the study sponsor or research team.

Aqsa Anwar

CONTACT

[email protected]

0321-5172551

Sponsors and collaborators

Lead sponsor

Ibadat International University, Islamabad

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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