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

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.

• VISUAL FEEDBACK (Behavioral): 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.
• Pressure Biofeedback (Behavioral): 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.

Primary outcomes

• Numeric Pain Rating Scale [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.
• Neck Disability Index [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.
• Range of Motion [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

Sex: All, ages: 19 Years to 44 Years, accepts healthy volunteers

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

• Marium Khalid, MSOPMT, Principal investigator, Ibadat International University, Islamabad