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Reciprocal Inhibition vs PNF for Cervical Spondylitis (RI-PNF-CS)

4 giugno 2026 aggiornato da: Dr. Marium Zafar, University of Faisalabad

Comparative Effects of Reciprocal Inhibition Technique and Passive PNF Stretching on Pain, Functional Disability, and Range of Motion in Cervical Spondylitis

Cervical spondylitis is a common cause of chronic neck pain and limited function. Physiotherapists often use two manual techniques: Reciprocal Inhibition (RI) and Passive Proprioceptive Neuromuscular Facilitation (PNF) stretching. However, no previous study has directly compared these two techniques in patients with confirmed cervical spondylitis. This randomized controlled trial will include 60 patients diagnosed with cervical spondylitis based on clinical and imaging findings. Participants will be randomly divided into two equal groups. Group A will receive Reciprocal Inhibition Technique. Group B will receive Passive PNF Stretching. Both groups will receive 12 sessions over 4 weeks, with three sessions per week on alternate days. Pain will be measured using the Visual Analog Scale (VAS). Functional disability will be measured using the Neck Disability Index (NDI). Cervical range of motion will be measured using a standard goniometer. All measurements will be taken at baseline and after 4 weeks of treatment. The goal is to determine which technique is more effective for reducing pain, improving function, and increasing neck mobility in cervical spondylitis patients

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: Passive PNF Stretching Group
Participants receive Passive Proprioceptive Neuromuscular Facilitation stretching for cervical spine.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Pain Intensity
Lasso di tempo: Baseline and after 4 weeks of intervention
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.
Baseline and after 4 weeks of intervention
Change in Neck Disability Index Score
Lasso di tempo: Baseline and after 4 weeks of intervention
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.
Baseline and after 4 weeks of intervention
Change in Cervical Range of Motion
Lasso di tempo: Baseline and after 4 weeks of intervention
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Effettivo)

24 maggio 2026

Completamento dello studio (Stimato)

15 giugno 2026

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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