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临床试验/CTRI/2025/08/093857
CTRI/2025/08/093857
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The Effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on improving Severity, Range of Motion and Quality of Life in patients with Chronic Cervical Dystonia A Pre Post Interventional study

Dr Tanisha Mali1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月14日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Tanisha Mali
入组人数
25
试验地点
1
主要终点
1. Cervical Dystonia: Toronto Western Spasmodic

概览

简要总结

Title

The Effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on improving Severity, Range of Motion and Quality of Life in patients with chronic Cervical Dystonia – a pre-post interventional study

Overview

This study investigates the combined effect of Cervical Proprioceptive Neuromuscular Facilitation (PNF) and Pressure Biofeedback in patients with chronic Cervical Dystonia (CD), a neurological movement disorder characterized by involuntary muscle contractions in the neck, leading to abnormal postures, pain, reduced range of motion (ROM), and diminished quality of life (QoL).

Objectives

To assess whether the intervention improves:

  1. Severity of cervical dystonia

  2. Range of motion of the cervical spine

  3. Quality of life of affected individuals

Rationale

Current first-line treatments like Botulinum Toxin injections provide symptomatic relief but often leave residual disability. There is limited research on combining PNF with pressure biofeedback as a therapeutic alternative for CD.

Methodology

Design: Pre-post interventional study

Sample Size: 25 participants

Duration: 8 weeks - 3 sessions per week

Population: Adults aged 20 to 60 with chronic CD, diagnosed greater than 1 year, TWSTRS score more than 35, no BoNT in last 6 months

Tools Used:

  1. CD Severity Scale (CDSS) for severity

  2. Goniometer for ROM

  3. CDQoL-24 Questionnaire for quality of life

  4. TWSTRS for baseline inclusion

Intervention

PNF: Targeting cervical flexors, extensors, lateral flexors, and rotators using the Contract Relax Antagonist Contract (CRAC) technique

Pressure Biofeedback: Sub-occipital positioning of a pressure sensor to facilitate deep neck flexor activation and control

Data Analysis

Pre- and post-intervention data will be compared using Paired t-test or Wilcoxon Signed Rank Test depending on data normality.

p-value less than 0.05 considered significant.

Data analyzed using SPSS v29

Primary Hypothesis

Null Hypothesis (H0)

There will be no significant effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on severity, range of motion, and quality of life in patients with chronic Cervical Dystonia.

Alternative Hypothesis (H1)

There will be a significant effect of Cervical Proprioceptive Neuromuscular Facilitation along with Pressure Biofeedback on severity, range of motion, and quality of life in patients with chronic Cervical Dystonia.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Individuals with chronic (1 year post symptoms) Cervical Dystonia.
  • Diagnosed with cervical dystonia by a physician.
  • Age group of 20-60 years
  • Both the genders
  • Individuals with Toronto Western Spasmodic Torticollis Rating Scale score of minimum
  • No history of Botulinum Toxin Injection taken in past 6 months.

排除标准

  • Individuals with acute Cervical Dystonia.
  • Individuals persisting other cervical deformities along with cervical dystonia.
  • Participants who have taken Botulinum Toxin Injection in less than past 6 months span.

结局指标

主要结局

1. Cervical Dystonia: Toronto Western Spasmodic

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

Torticollis Rating Scale.

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

2. Severity: Cervical Dystonia Severity Scale (CDSS)

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

3. Range of Motion: Goniometry

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

4. Quality of Life: Cervical Dystonia questionnaire 24

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

(CDQ-24)

时间窗: 1. baseline data: 1st day of treatment | 2. Final data: after 8 weeks of treatment which will be the result data.

次要结局

未报告次要终点

研究者

发起方
Dr Tanisha Mali
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tanisha Mali

Dr. G. D. Pol Foundation, YMT College of Physiotherapy

研究点 (1)

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