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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

7 september 2026 bijgewerkt door: Ibadat International University, Islamabad
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

44

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan
        • Werving
        • Hope Physiotherapy Clinic
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
Ander: Pressure Biofeedback-Assisted Deep Cervical Flexor Training
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
Ander: Scapular Stabilization Exercises
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
Ander: Standard Physiotherapy
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.
Actieve vergelijker: Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
Ander: Pressure Biofeedback-Assisted Deep Cervical Flexor Training
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
Ander: Standard Physiotherapy
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Neck Flexor Endurance Test
Tijdsspanne: Baseline and after 4 weeks of treatment
Measure cervical flexor muscle endurance
Baseline and after 4 weeks of treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ibadat International University, Islamabad

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • • 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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 juni 2026

Primaire voltooiing (Geschat)

15 september 2026

Studie voltooiing (Geschat)

24 september 2026

Studieregistratiedata

Eerst ingediend

7 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2026

Eerst geplaatst (Werkelijk)

11 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

7 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IIUI/RERC/ADT/2026/06/342

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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