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

2026年6月4日 更新者: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

調査の概要

状態

積極的、募集していない

詳細な説明

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.

研究の種類

介入

入学 (実際)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Punjab Province
      • Faisalābad、Punjab Province、パキスタン、3800
        • The University of Faisalabad

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Pain Intensity
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月1日

一次修了 (実際)

2026年5月24日

研究の完了 (推定)

2026年6月15日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月10日

QC基準を満たした最後の更新が送信されました

2026年6月4日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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