- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07637812
Reciprocal Inhibition vs PNF for Cervical Spondylitis (RI-PNF-CS)
Comparative Effects of Reciprocal Inhibition Technique and Passive PNF Stretching on Pain, Functional Disability, and Range of Motion in Cervical Spondylitis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Study Design This is a single-blinded, parallel-group, randomized controlled trial. The study will be conducted at the Neuro-Rehabilitation Department of Medina Teaching Hospital and The Canal Hospital Faisalabad, Pakistan. The total duration of the study is expected to be 6 months, including recruitment, intervention, and data analysis.
Ethical Approval The study protocol has been approved by the Ethical Review Committee of Medina Teaching Hospital (approval number IRB-MTH-2025-042). The study will be conducted in accordance with the Declaration of Helsinki. All participants will provide written informed consent before enrollment.
Participants A total of 60 participants with confirmed cervical spondylitis will be recruited. Diagnosis will be confirmed by MRI or radiograph showing cervical spine involvement. Additional inclusion criteria are: age 25 to 65 years, chronic neck pain lasting more than 4 months, Visual Analog Scale score of 7 or higher, and willingness to provide informed consent. Exclusion criteria are: upper limb fracture or recent injury, cervical radiculopathy with neurological deficit, systemic diseases such as rheumatoid arthritis, congenital cervical deformity, cognitive impairment, and previous cervical spine surgery.
Randomization and Blinding Participants will be randomly assigned to one of two groups using a computer-generated random sequence. Allocation will be concealed using opaque sealed envelopes. The outcome assessor who measures VAS, NDI, and cervical range of motion will be blinded to group allocation. Participants and the treating physiotherapist cannot be blinded due to the nature of the manual techniques.
Intervention: Group A (Reciprocal Inhibition) Participants will sit upright with back support. The therapist will stand behind the participant and passively move the neck until the first resistance is felt. The participant will then perform a pain-free isometric contraction against the therapist's resistance for 10 seconds. After relaxation, the therapist will move the neck into a greater range of motion. Three repetitions will be performed for cervical flexion, extension, left lateral flexion, right lateral flexion, left rotation, and right rotation. A total of 12 sessions will be given over 4 weeks, with three sessions per week on alternate days. Each session lasts approximately 20 minutes. All interventions will be performed by a licensed physiotherapist with at least 3 years of experience.
Intervention: Group B (Passive PNF Stretching) Participants will sit comfortably. The therapist will apply one stretch per cervical muscle group. Each stretch includes a 30-second passive hold, followed by a 10-second push where the participant gently pushes against the therapist, and then 10 seconds of relaxation. Two sets will be performed for each movement: cervical flexion, extension, left lateral flexion, right lateral flexion, left rotation, and right rotation. A recovery period of 30 seconds will be allowed between sets. The same frequency and duration as Group A: 12 sessions over 4 weeks, three sessions per week on alternate days. Each session lasts approximately 20 minutes.
Outcome Measures All outcomes will be measured at baseline and immediately after the 4-week intervention period.
Pain: Visual Analog Scale (VAS), a 0 to 10 cm line where 0 means no pain and 10 means worst possible pain.
Functional Disability: Neck Disability Index (NDI), a 10-item questionnaire with scores from 0 to 50, converted to a percentage. Higher scores indicate greater disability.
Cervical Range of Motion: Measured using a standard universal goniometer. Movements measured include flexion, extension, left lateral flexion, right lateral flexion, left rotation, and right rotation. Three trials will be performed for each movement, and the average will be recorded.
Statistical Analysis Data will be analyzed using SPSS version 25. Descriptive statistics (mean, standard deviation) will be calculated for each group. Normality will be checked using the Shapiro-Wilk test. Within-group comparisons (pre vs post) will be performed using a paired t-test if data are normally distributed, or Wilcoxon signed-rank test if not normally distributed. Between-group comparisons (RI vs PNF) will be performed using an independent t-test or Mann-Whitney U test as appropriate. A p-value less than 0.05 will be considered statistically significant. Effect sizes will be reported as Cohen's d.
Data Management All participant data will be anonymized and stored in a password-protected computer. Only the principal investigator and authorized research team members will have access. Data will be retained for 5 years after study completion.
Dissemination The results of this study will be submitted for publication in a peer-reviewed physiotherapy or rehabilitation journal, regardless of whether the findings are positive or negative.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Faisalābad, Punjab Province, Pákistán, 3800
- The University of Faisalabad
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Confirmed diagnosis of cervical spondylitis by MRI or radiograph.
- Chronic neck pain lasting more than 4 months.
- Visual Analog Scale (VAS) score of 7 or higher.
- Age between 25 and 65 years.
- Willing to provide written informed consent.
- Bacteriological or histological confirmation where available.
Exclusion Criteria:
- Upper limb fracture or recent injury.
- Cervical radiculopathy with neurological deficit.
- Systemic diseases (e.g., rheumatoid arthritis, diabetes with neuropathy).
- Congenital cervical deformity.
- Cognitive impairment preventing cooperation.
- Previous cervical spine surgery.
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: Reciprocal Inhibition Group
Participants receive Reciprocal Inhibition Technique for cervical spine.
|
Patient sits upright with back support.
Therapist stands behind and passively moves the patient's neck until first resistance.
Patient then performs a pain-free isometric contraction against therapist's resistance for 10 seconds.
After relaxation, therapist moves neck into greater range of motion.
Three repetitions performed for cervical flexion, extension, lateral flexion, and rotation.
Total 12 sessions over 4 weeks (3 sessions/week, alternate days).
Performed by a licensed physiotherapist.
Patient sits comfortably.
Therapist applies one stretch per cervical muscle group.
Each stretch: 30-second passive hold, followed by 10-second push (patient gently pushes against therapist), then 10 seconds relaxation.
Two sets performed for cervical flexion, extension, lateral flexion, and rotation.
Recovery period between sets.
Total 12 sessions over 4 weeks (3 sessions/week, alternate days).
Performed by a licensed physiotherapist.
|
|
Aktivní komparátor: Passive PNF Stretching Group
Participants receive Passive Proprioceptive Neuromuscular Facilitation stretching for cervical spine.
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Patient sits comfortably.
Therapist applies one stretch per cervical muscle group.
Each stretch: 30-second passive hold, followed by 10-second push (patient gently pushes against therapist), then 10 seconds relaxation.
Two sets performed for cervical flexion, extension, lateral flexion, and rotation.
Recovery period between sets.
Total 12 sessions over 4 weeks (3 sessions/week, alternate days).
Performed by a licensed physiotherapist.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Pain Intensity
Časové okno: Baseline and after 4 weeks of intervention
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Pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 cm line where 0 means no pain and 10 means worst possible pain.
Higher score indicates worse pain.
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Baseline and after 4 weeks of intervention
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Change in Neck Disability Index Score
Časové okno: Baseline and after 4 weeks of intervention
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Neck Disability Index (NDI) is a 10-item questionnaire.
Each item scores 0 to 5. Total score ranges from 0 to 50, converted to a percentage.
Higher percentage indicates greater disability.
Minimum detectable change is 5 points.
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Baseline and after 4 weeks of intervention
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Change in Cervical Range of Motion
Časové okno: Baseline and after 4 weeks of intervention
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Active cervical range of motion measured using a standard universal goniometer.
Movements measured: flexion, extension, right lateral flexion, left lateral flexion, right rotation, left rotation.
Measured in degrees.
Three trials performed per movement; average recorded.
|
Baseline and after 4 weeks of intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
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
- Bolest
- Neurologické projevy
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest krku
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Terapeutika
- Modality fyzikální terapie
- Péče o pacienty
- Cvičební terapie
- Rehabilitace
- Následná péče
- Kontinuita péče o pacienty
- Cvičení
- Cvičení protahování svalů
Další identifikační čísla studie
- TUF/EIRB/ 207 /26
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