此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Comparative Effects of Pressure and Visual Biofeedback Training on Pain, Disability, Range of Motion Among Patients With Forward Head Posture Correction: A Randomized Controlled Trial

2026年10月15日 更新者:Marium Khalid、Ibadat International University, Islamabad

The study will take place at Akbar Niazi Teaching Hospital and AL kauther International hospital, Bhara Kahu, Islamabad with formal permission obtained from the institution. Patients with forward head posture, who meet the inclusion criteria, will be selected and asked for consent. Participants will be randomly assigned to either a pressure bio feedback training group or a visual biofeedback training group using a computer randomizer. Before starting the training, baseline measurements of neck muscle activation and posture will be recorded. Group1will receive pressure bio feedback training using a cuff, while Group 2 will use visual feedback through a mirror or screen to correct posture. An 6 weeks intervention will be implemented, with treatments administered three times per week. Outcome measures will be assessed at baseline and again at the conclusion of the 6 weeks intervention period. The results will be analyzed using the latest version of SPSS (Statistical Package for the Social Sciences).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Study Description

This study is a two-arm, parallel-group, randomized controlled trial designed to compare the effects of **pressure biofeedback training** and **visual biofeedback training** in patients with **forward head posture (FHP)**. The study will evaluate the effects of both biofeedback modalities on pain intensity, functional disability, cervical range of motion, and postural alignment.

The study will be conducted at **Akbar Niazi Teaching Hospital and Al Kauthar International Hospital, Bhara Kahu, Islamabad**, after obtaining formal permission from the respective institutions. Participants diagnosed with forward head posture who fulfill the predefined inclusion and exclusion criteria will be recruited for the study. Eligible participants will be informed about the purpose, procedures, potential benefits, and possible risks of the study, and written informed consent will be obtained before enrollment.

A total of **38 participants** will be recruited and randomly allocated into two equal groups, with **19 participants in each group**. Randomization will be performed using a computer-generated randomization method to minimize selection bias and ensure an approximately equal distribution of participants between the two intervention groups.

Intervention Groups

**Group 1 - Pressure Biofeedback Training:** Participants allocated to the pressure biofeedback group will receive cervical muscle activation and postural training using a pressure biofeedback cuff. The cuff will be positioned appropriately to provide feedback regarding cervical movement and muscle activation. Participants will be instructed to perform the prescribed exercises while maintaining the desired cervical position and controlling the pressure level according to the study protocol. The pressure biofeedback will provide immediate feedback to assist participants in developing appropriate deep cervical muscle activation and maintaining improved head and neck alignment.

**Group 2 - Visual Biofeedback Training:** Participants allocated to the visual biofeedback group will receive postural and cervical control training using visual feedback. Visual feedback will be provided through a mirror and/or visual display screen. Participants will be instructed to observe their head and neck position and actively correct forward head posture according to predefined postural landmarks and instructions provided by the therapist. The visual feedback will allow participants to immediately observe and modify their cervical alignment during the prescribed exercises.

Intervention Duration and Frequency

Both groups will receive their respective biofeedback interventions for **6 weeks**, with treatment sessions conducted **three times per week**. The intervention will therefore consist of a structured 6-week training period with comparable treatment frequency between the two groups. Both groups will receive standardized instructions regarding exercise performance, posture correction, and adherence to the intervention protoco Outcome Assessment

Baseline assessment will be performed before commencement of the intervention. The primary and secondary outcome measures will be assessed using standardized and appropriate measurement procedures.

The study outcomes will include:

  1. **Pain intensity:** Pain will be assessed using the **Numeric Pain Rating Scale (NPRS)**.
  2. **Functional disability:** Neck-related functional disability will be assessed using the **Neck Disability Index (NDI)**.
  3. **Cervical range of motion:** Cervical flexion, extension, right rotation, and left rotation will be assessed using **goniometry**.
  4. **Postural alignment:** Forward head posture will be assessed using the **craniovertebral angle (CVA)**, with a smaller CVA indicating greater forward head positioning.

Outcome measurements will be recorded at **baseline, after 3 weeks, and after completion of the 6-week intervention** to evaluate changes over time and differences between the two intervention groups.

Randomization and Allocation

After completion of baseline assessment and confirmation of eligibility, participants will be randomly assigned in a **1:1 ratio** to either the pressure biofeedback training group or the visual biofeedback training group. A computer-based randomization procedure will be used for group allocation.

Data Management and Statistical Analysis

All collected data will be coded and entered into the statistical software **IBM SPSS Statistics**, using the latest available version at the time of analysis. Descriptive statistics will be used to summarize participant characteristics and outcome measures. The **Shapiro-Wilk test** will be used to assess the normality of continuous data.

Depending on the distribution of the data and the assumptions of the statistical tests, appropriate parametric or non-parametric tests will be applied. For repeated measurements within groups, appropriate repeated-measures statistical procedures will be used. Between-group comparisons will be performed to determine whether there are statistically significant differences in changes in pain, disability, cervical range of motion, and postural alignment between the pressure biofeedback and visual biofeedback groups.

Statistical significance will be considered at **p < 0.05**. Where appropriate, effect sizes and confidence intervals will also be reported to provide an estimate of the magnitude and precision of the treatment effects.

Primary Purpose

The primary purpose of this randomized controlled trial is to determine whether pressure biofeedback training or visual biofeedback training is more effective in improving clinical and postural outcomes in individuals with forward head posture.

The study will specifically compare the effects of the two interventions on **pain intensity, neck-related functional disability, cervical range of motion, and craniovertebral angle**, thereby determining which biofeedback modality provides greater clinical benefit over the 6-week intervention period.

研究类型

介入性

注册 (估计的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 44年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients between 19 and 44 years with primary complain of neck pain Those with craniovertebral angle more than 48-50 degreeswould be incorporated Eagerness to take part and give informed consent Get a score of greater than 3 and having less than 8 on NPRS

Exclusion Criteria:

Those with craniovertebral angle less than48-50 degree would be incorporated Eagerness to take part and give informed consent Get a score of greater than 3 and having less than 8 on NPRS

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Pressure Biofeedback

Active Comparator Arm: Pressure Biofeedback Training

Participants assigned to the active comparator group (Pressure Biofeedback Training) will receive a structured cervical postural correction and deep cervical muscle activation training program using a pressure biofeedback cuff. The intervention is designed to provide objective pressure-based feedback during exercise, allowing participants to monitor and control their cervical position and muscle activation while performing the prescribed exercises.

The pressure biofeedback cuff will be appropriately positioned in the cervical region according to the standardized study protocol. Participants will be instructed to maintain a neutral cervical position and perform the prescribed cervical stabilization and postural control exercises while monitoring the pressure changes displayed on the pressure biofeedback device.

Pressure Biofeedback

Participants will receive pressure biofeedback during the intervention sessions using a pressure-sensing device. The device will detect changes in pressure associated with the targeted movement or muscle activity and provide immediate visual feedback of the measured pressure. Participants will be instructed to observe the feedback and adjust their muscle activation or movement to achieve and maintain the predefined target pressure. The intervention will be delivered according to a standardized protocol throughout the treatment sessions.

实验性的:Visual Biofeedback

Participants will receive visual biofeedback during the intervention sessions. Information related to the targeted physiological or biomechanical parameter will be measured using the study's assessment/biofeedback system and presented visually on a screen in real time. Participants will be instructed to observe the visual feedback and modify their performance or movement according to the predefined target. The visual feedback will be provided consistently across intervention sessions according to the study protocol.

Intervention: Visual Biofeedback

Participants will receive visual biofeedback during the intervention sessions. Information related to the targeted physiological or biomechanical parameter will be measured using the study's assessment/biofeedback system and presented visually on a screen in real time. Participants will be instructed to observe the visual feedback and modify their performance or movement according to the predefined target. The visual feedback will be provided consistently across intervention sessions according to the study protocol.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Numeric Pain Rating Scale
大体时间:participants wiill be assesed at baseline, then at week 3 and then at week 6

Pain intensity will be assessed as an outcome measure to determine the effect of the intervention on participants' perceived pain. Pain will be measured using a validated pain-rating scale, such as the Visual Analogue Scale (VAS) or Numeric Pain Rating Scale (NPRS). Participants will rate the intensity of their pain at the specified assessment time points, with higher scores indicating greater pain intensity. Changes in pain scores from baseline to post-intervention will be evaluated to determine the effect of the intervention.

participants wiill be assesed at baseline, then at week 3 and then at week 6
Neck Disability Index
大体时间:Participants will be assesd as baseline then at week 3, and then at week 6

Neck Disability Index (NDI)

The Neck Disability Index (NDI) will be used to assess neck-related pain and disability and its impact on participants' daily activities. The NDI is a 10-item patient-reported questionnaire covering areas such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, with a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. The NDI score will be assessed at the predefined time points to evaluate changes in neck disability following the intervention.

Participants will be assesd as baseline then at week 3, and then at week 6
Range of Motion
大体时间:Participants will be assed at baseline, then week 3 and then week 6

Cervical Range of Motion (ROM)

Cervical range of motion will be assessed to determine changes in neck mobility following the intervention. Cervical movements including flexion, extension, lateral flexion, and rotation will be measured using a standardized method, such as a cervical goniometer or digital inclinometer. The range of movement will be recorded in degrees at the specified assessment time points. Changes in cervical ROM from baseline to post-intervention will be evaluated to determine ch

Participants will be assed at baseline, then week 3 and then week 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Marium Khalid, MSOPMT、Ibadat International University, Islamabad

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月5日

初级完成 (估计的)

2026年10月15日

研究完成 (估计的)

2026年10月20日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月16日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • IIUI//RERC/ADT/2026/02/233

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.