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

4 de junho de 2026 atualizado por: 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

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Pain Intensity
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2026

Conclusão Primária (Real)

24 de maio de 2026

Conclusão do estudo (Estimado)

15 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

1 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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