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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).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

44

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Federal
      • Islamabad、Federal、パキスタン、44000
        • 募集
        • Ibadat International University
        • コンタクト:
        • コンタクト:

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

19年~44年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

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
アクティブコンパレータ: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.

実験的: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.

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
Numeric Pain Rating Scale
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Marium Khalid, MSOPMT、Ibadat International University, Islamabad

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3月5日

一次修了 (推定)

2026年10月15日

研究の完了 (推定)

2026年10月20日

試験登録日

最初に提出

2026年9月28日

QC基準を満たした最初の提出物

2026年9月28日

最初の投稿 (実際)

2026年10月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月16日

QC基準を満たした最後の更新が送信されました

2026年10月15日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • IIUI//RERC/ADT/2026/02/233

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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