- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07691151
Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining for Chronic Mechanical Neck Pain (INT-CMNP)
Comparison of Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining on Pain and Disability in Chronic Neck Pain: A Randomized Clinical Trial
Persistent pain, functional disability, cervical motor control deficit, and abnormal posture are associated with chronic mechanical neck pain. This study aimed to evaluate the efficacy of an integrated physiotherapy program of cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback versus conventional cervical physiotherapy in patients with chronic mechanical neck pain through a randomized controlled trial.
40 eligible participants were randomly assigned to the experimental or control group. The two groups were all given supervised physiotherapy three times a week for 6 weeks plus a standardized home exercise program. The main aim was to investigate the efficacy of the interventions on pain intensity and neck related disability. Secondary outcomes were CROM, DCFE, head position, and patient perceived recovery. Outcome measures were conducted at both baseline and the end of the six-week intervention.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Chronic mechanical neck pain is one of the most prevalent musculoskeletal conditions and is related to ongoing pain, diminished cervical movement, poor neck muscle control, poor posture, and diminished functional ability. Conventional physiotherapy emphasizes the mobility, strengthening, stretching and postural correction of the cervical region. Recent research indicates that cervical motor control, trunk stabilization and respiratory training may be beneficial when integrated into a rehabilitation program, as multiple aspects of spinal stability and motor control can be targeted.
The study was designed as a single center, parallel-group, assessor-blinded randomized controlled trial, to compare the effectiveness of integrated physiotherapy program to conventional cervical physiotherapy in subjects with chronic mechanical neck pain.
Participants were recruited from the outpatient physiotherapy department of Thumbay Physical Therapy and Rehabilitation Hospital, Ajman, UAE, where they met the inclusion criteria for having mechanical neck pain with a duration of at least three months. After obtaining informed consent, participants were allocated by a computer-generated random sequence in a 1:1 ratio to either the experimental or control group, with allocation concealed.
The experimental group received an integrated rehabilitation program that included cervical motor control training with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises and traditional physiotherapy interventions as clinically needed. The control group received conventional cervical physiotherapy which included cervical range of motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and other standard physiotherapy treatment. Both groups underwent supervised treatment three times a week for six weeks and an identical home exercise program during the intervention.
The primary outcome measures included intensity of pain (Numeric Pain Rating Scale [NPRS]) and neck-related disability (Neck Disability Index [NDI]). Secondary outcome measures were the cervical range of motion, deep cervical flexor endurance, craniovertebral angle for head posture and the Global Rating of Change (GROC). Assessment of outcomes was conducted at baseline and at the end of the six-week interventions by an assessor who was not aware of the allocation of the interventions.
This study aimed to evaluate the effectiveness of an integrated physiotherapy approach including cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback in comparison to a conventional cervical physiotherapy approach for reduction of pain, disability, and cervical function and postural control in patients with chronic mechanical neck pain.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Ajman Emirate
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Ajman, Ajman Emirate, Spojené arabské emiráty
- Thumbay Physical Therapy & Rehabilitation Hospital
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age in the range 18-60 years.
- CNMP (lasting more than 3 months).
- NPRS score ≥ 3.
- Head Impact Test (HIT-6) score < 50.
- Absence of clinical signs of cervical radiculopathy.
- Capacity to comprehend study procedures, follow directions for exercising and sign informed consent in writing.
- Diaphragmatic function impairment by the DNS diaphragm test with asymmetric or inadequate rib expansion laterally, high elevation of upper chest or shoulder girdle and diminished truncal stabilization during inhalation.
Exclusion Criteria:
- Participants were excluded if they had cervical radiculopathy, cervical myelopathy, previous cervical spine surgery, spinal fracture, inflammatory arthritis, malignancy, neurological disorders, pregnancy, or any other serious spinal pathology that would make it difficult for the participant to participate in the rehabilitation programme. People with cognitive deficits or any medical condition which hampered their safe involvement in the exercise programme were also excluded.
Studijní plán
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 |
|---|---|
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Experimentální: Integrated Physiotherapy
Participants were treated with a comprehensive physiotherapy intervention that included cervical motor control exercises with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and additional physiotherapy interventions as clinically necessary.
Three times per week for 6 weeks.
In addition, a standardized home exercise program was performed during the intervention.
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Participants were given an integrated physiotherapy program which comprised motor control training for the cervical spine with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and a standardized home exercise program.
Three treatment sessions per week for six weeks were conducted under supervision.
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Aktivní komparátor: Conventional Physiotherapy
All participants underwent conventional cervical physio, which included cervical range of motion exercises, cervical isometric strengthening, upper trapezius and levator scapulae and pectoral muscles stretching, scapulothoracic strengthening, proprioceptive training, postural correction exercises and intermittent cervical traction as clinically indicated.
Treatment was given three times a week for 6 weeks.
A standardized home exercise program was also performed by the participants during the intervention period.
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Conventional cervical physiotherapy included cervical range-of-motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and a standardized home exercise program.
Supervised treatment was provided three times per week for six weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neck Disability
Časové okno: Baseline and 6 weeks
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Neck-related disability will be assessed using the NDI.
Higher scores indicate greater disability.
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Baseline and 6 weeks
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Pain Intensity
Časové okno: Baseline and 6 weeks
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Pain intensity will be assessed using the NPRS.
The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower scores indicate reduced pain intensity.
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Baseline and 6 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cervical Range of Motion
Časové okno: Baseline and 6 weeks
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Cervical range of motion will be measured in flexion, extension, rotation, and lateral flexion using standard clinical assessment procedures.
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Baseline and 6 weeks
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Deep Cervical Flexor Endurance
Časové okno: Baseline and 6 weeks
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Deep cervical flexor muscle endurance will be assessed using a standardized endurance test.
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Baseline and 6 weeks
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Head Posture
Časové okno: Baseline and 6 weeks
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Forward head posture will be assessed by measuring the craniovertebral angle.
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Baseline and 6 weeks
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Global Rating of Change
Časové okno: 6 weeks
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Participant-perceived overall improvement will be assessed using the GROC scale.
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6 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- COHSSTD32Jan2026
- RB-COHS-STD-32-Jan-2026 (Jiný identifikátor: Gulf Medical University, Ajman)
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