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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. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

44

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Pákistán
    • Punjab Province
      • Rawalpindi, Punjab Province, Pákistán
        • Nábor
        • Hope Physiotherapy Clinic
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
Jiný: 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
Jiný: 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
Jiný: 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.
Aktivní komparátor: Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
Jiný: 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
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neck Disability - Neck Disability Index (NDI)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The Neck Flexor Endurance Test
Časové okno: Baseline and after 4 weeks of treatment
Measure cervical flexor muscle endurance
Baseline and after 4 weeks of treatment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ibadat International University, Islamabad

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • • 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.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. června 2026

Primární dokončení (Odhadovaný)

15. září 2026

Dokončení studie (Odhadovaný)

24. září 2026

Termíny zápisu do studia

První předloženo

7. září 2026

První předloženo, které splnilo kritéria kontroly kvality

7. září 2026

První zveřejněno (Aktuální)

11. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IIUI/RERC/ADT/2026/06/342

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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