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

NCT07814833 — Not applicable, Recruiting, 44 participants, Ibadat International University, Islamabad

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RegistryNCT07814833
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment44 (Estimated)
SponsorIbadat International University, Islamabad (Other)
ConditionsCervical Spondylosis
InterventionsPressure Biofeedback-Assisted Deep Cervical Flexor Training, Scapular Stabilization Exercises, Standard Physiotherapy (Other)
Datesstart 2026-06-03, primary completion 2026-09-15 (estimated), completion 2026-09-24 (estimated), first posted 2026-09-11, last updated 2026-09-28
Locations1 site in Pakistan

Related Papers Related Patents Related Grants Related Experts
All trials for Cervical Spondylosis All trials of Pressure Biofeedback-Assisted Deep Cervical Flexor Training All trials of Scapular Stabilization Exercises

-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization ExerciExperimentalOther: Pressure Biofeedback-Assisted Deep Cervical Flexor Training; Other: Scapular Stabilization Exercises; Other: Standard Physiotherapy
Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard PhysiotherapyActive comparatorOther: Pressure Biofeedback-Assisted Deep Cervical Flexor Training; Other: Standard Physiotherapy
  • Pressure Biofeedback-Assisted Deep Cervical Flexor Training (Other): 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.
  • Scapular Stabilization Exercises (Other): 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.
  • 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.

+Outcome measures

Primary outcomes

  • Neck Disability - Neck Disability Index (NDI) [Baseline and 4 weeks of treatment.]: Measure: Functional disability related to neck pain measured using the Neck Disability Index.
  • Pain Intensity - Numeric Pain Rating Scale (NPRS) [Baseline and 4 weeks of treatment]: Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale.
  • Universal Goniometer [Baseline and 4 weeks of treatment.]: Measure: Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion, and right/left rotation.

Secondary outcomes

  • The Neck Flexor Endurance Test [Baseline and 4 weeks of treatment]: Measure: Cervical flexor muscle endurance.

+Eligibility

Sex: All, ages: 40 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Hope Physiotherapy ClinicRawalpindi, Punjab ProvincePakistanRecruiting

+Publications

  • • 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.