NCT07814833

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 7, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Neck Disability - Neck Disability Index (NDI)

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

    Baseline and 4 weeks of treatment.

  • Pain Intensity - Numeric Pain Rating Scale (NPRS)

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

    Baseline and 4 weeks of treatment

  • Universal Goniometer

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

    Baseline and 4 weeks of treatment.

Secondary Outcomes (1)

  • The Neck Flexor Endurance Test

    Baseline and 4 weeks of treatment

Study Arms (2)

Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci

EXPERIMENTAL
Other: Pressure Biofeedback-Assisted Deep Cervical Flexor TrainingOther: Scapular Stabilization ExercisesOther: Standard Physiotherapy

Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy

ACTIVE COMPARATOR
Other: Pressure Biofeedback-Assisted Deep Cervical Flexor TrainingOther: Standard Physiotherapy

Interventions

Deep cervical flexor (DCF) training will be performed using a pressure biofeedback unit to facilitate selective activation of the longus colli and longus capitis. Participants will lie supine with hips and knees flexed, with the cuff placed beneath the cervical spine at C4-C5 and inflated to a baseline pressure of 20 mmHg. Gentle cranio-cervical flexion will be performed by nodding and drawing the chin inward while maintaining head contact with the surface and avoiding compensatory superficial muscle activation. Target pressure will progress from 22 mmHg in Week 1 to 24, 26, and 28 mmHg in Weeks 2-4, respectively. Training will consist of 3 sets of 10 repetitions, with 5-second holds in Week 1 progressing to 10-second holds thereafter and 30-60 seconds of rest between sets. Arm lifts will be added in Week 3 and leg marching in Week 4. The intervention will be administered three times weekly for four consecutive weeks.

Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization ExerciGroup B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy

Scapular stabilization exercises will be performed progressively for 4 weeks to improve scapular control, alignment, and stabilizer strength. In Week 1, seated scapular retraction and depression will be performed for 3 sets of 10 repetitions with 5-second holds and 60 seconds rest. In Week 2, scapular retraction will progress using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement. In Week 3, wall slides and prone Y and T raises will be performed for 3 sets of 8-10 repetitions. In Week 4, scapular stabilization with shoulder flexion and abduction will be performed for 3 sets of 10 repetitions. All exercises will emphasize controlled movement, neutral alignment, and avoidance of compensatory shoulder or trunk movements. Sessions will be conducted three times weekly.

Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci

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.

Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization ExerciGroup B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hope Physiotherapy Clinic

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (1)

  • • Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: a systematic review and meta-analysis. Musculoskeletal Science and Practice. 2020;50:102220. • Saleh MSM, Rehab NI, Sharaf MAF. Effect of deep cervical flexors training on neck proprioception, pain, muscle strength and dizziness in patients with cervical spondylosis: A randomized controlled trial. Phys Ther Rehabil. 2018;5(1):14. • Fatima I, Ashraf A, Khalid K. Effectiveness of thoracic manipulation versus scapular stabilization exercises on pain and functional disability in cervical spondylosis. Journal of Nursing and Allied Health. 2024;2(01). • Ashfaq R, Riaz H. Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial. Pakistan Journal of Medical Sciences. 2021;37(2):550. • Modarresi S, et al. A systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual analog scale for use in people with neck pain. The Clinical Journal of Pain. 2022;38(2):132-148.

    BACKGROUND

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start

June 3, 2026

Primary Completion

September 15, 2026

Study Completion

September 24, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations