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55 (); 80-85
doi:
10.1016/j.jor.2024.03.033

Posterior neck weighting an innovative and novel head orthosis for forward head posture correction: Randomized controlled trial

Hasselt University, Faculty of Rehabilitation Sciences, REVAL Rehabilitation Research Center, Hasselt, Belgium
Neuroscience, Graduate School of Health Sciences, Koç University, Turkey
Neuroscience and Biotechnology, Faculty of Science, Alexandria University, Egypt
Physical Therapy and Rehabilitation, Marmara University, Turkey
Department of Biomechanics, Faculty of Physical Therapy, Cairo University, Egypt
Physical Therapy Program, Batterjee Medical College, Jeddah, Saudi Arabia

⁎Corresponding author: Hussein Youssef. husseinahmedyoussef@gmail.com

Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

Muscle activity of the anterior and posterior elements of the cervical spine, both together actively contribute to the balance of the head position over the neck. Increasing muscular tension of the one cervical muscle group could induce poor motor control of cervical spine joints, this might contribute to the anterior position of the head with neck, known as forward head posture (FHP). We propose posterior neck weighting as an innovative orthosis to correct head posture within FHP participants and improve co-related mechanical neck pain.

Sixty-one participants with FHP; were randomly assigned to one of two groups posterior cervical weighing orthosis (PCWO) or deep cervical flexion (DCF) exercise. Each participant has been assessed for change in Craniovertebral Angle (CVA) as an indicator for FHP severity, and neck disability index (NDI).

Wilcoxon Signed Rank Test showed a statistically significant change difference regarding the degree of CVA improvements, and the score of NDI of pre-and post-intervention of the PCWO group (p < 0.0001), (p < 0.0001), and of the DCF group (p < 0.0001), (p = 0.0039), respectively. Mann–Whitney Test, showed a statistically significant difference between groups for CVA improvement (p < 0.0001), and NDI (p = 0.045). No correlation between CVA and NDI scores within the PCWO group (r = 0.129, p = 0.473), and within the DCF exercise group (r = 0.073, p = 0.71).

PCWO is a novel and innovative neck orthosis that is considered a promising intervention to correct FHP and improve correlated neck disability.

Keywords

Cervical
Forward head posture
Orthosis
Neck pain
1

1 Introduction

Forward head posture (FHP) is recognized as one of the common postural adaptations with a high prevalence of 66 % within the population.1 Individuals across different ages naturally develop FHP, which is characterized by anterior displacement of the head position in the sagittal plane relative to the neck and shoulders.2 Deviations within the sagittal plane are adapted by spinal modulation, evident by upper cervical (C1–C3) spine hyperextension and lower cervical (C4–C7) spine flexion.3 Cervical spine malalignment is associated with stressful changes in the posterior element of the cervical spine,4 and as a result it would affect the length-tension relationship,5 increase the muscular activity,6 limit the neck active range of motion (RoM),7 and eventually deteriorate cervical ROM proprioception.8

While many people with forward head posture (FHP) also experience neck pain, a recent study suggests this connection might be age-related.9 Adults and older adults with FHP seem to be more likely to have neck pain compared to adolescents with FHP.10 Furthermore, FHP posture might be associated with alterations in body balance,11 potentially distinguishing it from thoracic hyperkyphosis observed in younger populations.12

Neck pain which could result as a consequence of FHP is recognized as mechanical neck pain 13. Previous studies have demonstrated changes in the muscle activity of the anterior element of the cervical spine; accompanied by increased muscular tension of the posterior cervical muscle group, and associated with significant reduction of the anterior deep flexors of the neck mainly longus colli and longus capitis muscles.14,15 In addition, the poor activity of the deep extensor group was recorded in the semispinalis cervicis and upper multifidus muscles.16,17 Deficits within the activity of deep cervical musculature have been hypothesized to induce poor motor control of cervical spine joints.18

The literature review shows that previous studies have almost exclusively focused on improving neuromuscular control through activation of the deep cervical musculature to correct FHP and relieve the associated neck pain, that would not only, promote FHP correction, but also alleviate neck pain 19,20. In addition to deep flexors activation, neck orthosis has been investigated as a secondary treatment for FHP. Morningstar et al. reported immediate effect after one session of combined spinal manipulation and anterior head weighting on correction of FHP.21 Another study, showed that anterior head weight is effective in comparison to the conventional exercise protocols,22 However, the efficacy of posterior cervical weighting is not studied, and not considered yet.

Therefore, the purpose of the present study was to investigate the effects of an innovative posterior head weighting orthosis on Craniovertebral Angle (CVA), and neck disability in individuals with FHP.

2

2 Methods

2.1

2.1 Participants

This research followed a single-blind randomized controlled trial design and was conducted at the Department of Physical Therapy (PT) and Rehabilitation. The study received approval from the Institutional Review Board of the Faculty of Medicine at Alexandria University, Egypt (ID no. 0305072). We adhered to the ethical principles outlined in the Declaration of Helsinki. All participants received a thorough explanation of the study procedures and provided written informed consent before participating. The trial was registered on ClinicalTrials.Gov under the identifier number (ID: NCT04796051).

Between April 2021 to September 2021, patients were referred to our department with suspects of FHP from orthopedics clinic, eighty individuals were screened against the inclusion criteria, and ten of them were droped out. Inclusion criteria included; age range from 18 to 50 years old, craniovertebral angle (CVA) less than 48° assessed by the photogrammetric method,23 and those participants who also had to experience mechanical neck pain within the last 3 months. This type of pain is felt in the neck and/or shoulder area and can be caused by physical factors such as holding your neck in the same position for too long, jerky movements of the neck, or tightness in the neck muscles..24 Patients were excluded in case of history of spinal trauma, surgery, vertebral bone or disc pathology, postural deformity, radiating or referred pain to the upper extermities, neurological or vestibular disorders, body mass index (BMI) > 30.

2.2

2.2 Sample size Calculation

In the literature, the effect size (d) of deep cervical flexion for FHP correction was 0.97.25 The sample size was statistically calculated using a t-test of the difference between two independent means, the minimum required sample size was 40 patients (20 per arm) was needed to achieve 85 % test power with α = 5 % Types I error rate, as the number of groups = 2. Assuming a 20 % dropout rate, we, therefore, aimed to randomize approximately 50 participants (25 per group). The sample size was calculated using G. Power software. The level of statistical significance was set at p < 0.05.

2.3

2.3 Procedures

2.3.1

2.3.1 Randomization and blinding

Seventy participants were randomly allocated (1:1) to either the experimental group (EG) receiving posterior cervical weighing orthosis group (n = 35) or the control group (CG) receiving deep neck flexors exercise (n = 35). Concealed randomization is conducted at beginning of the study by an independent investigator using a computer-generated randomizer mobile application (RandomIZE).

2.3.2

2.3.2 Study design

Experimental group (EG) received posterior cervical weighing orthosis (PCWO) and active comparator arm of the control group (CG) received deep neck flexors exercise. The intervention device used in this study is called PCWO. It consists of a well-padded strap with adjustable Velcro closures. A 2-kg weight is attached to one end of the strap. Fig. 1 illustrates how the PCWO is positioned: securely wrapped around the jaw curve and fastened at the top of the head with another Velcro closure.

Posterior cervical weighting (PCWO) orthosis.
Fig. 1 Posterior cervical weighting (PCWO) orthosis.

Participants within EG used PCWO for 10 min/3 times a day, for a total of 30 min a day. PCWO is patented and registered in the Egyptian Patent Office, Academy of Scientific Research and Technology, with a special identifier number. All the rights for commercial or scientific purposes usages must be after granting written permission by the patent owner to another individual/organization to make, use, sell etc. his patented invention.

The control group (CG) performed exercises specifically targeting the deep neck flexor muscles (longus capitis and longus colli). They did 3 sets of 15 repetitions, 3 times a day. Here's how the exercise was performed: participants lied comfortably on their back with their head resting flat. They then gently tucked their chin towards their chest, holding this slight chin tuck position without using any of the larger neck muscles on the sides.26

The main investigator was responsible for instructing the EG how to correctly wear and adjust PCWO since each participant has their orthosis, besides inspecting the exercise procedures for each participant of CG to ensure their compatibility to independently perform the exercise at home. All of the intervention protocols were performed every day for six consecutive weeks.

2.3.3

2.3.3 Outcome measures

Clinical outcome measures were assessed at baseline before and six weeks following the intervention.

The primary outcome measure was the change in Craniovertebral Angle (CVA), which is an angle formed at the intersection of a line connecting the tragus of the ear and the spinous process of C7 with a horizontal line (imaginary line parallel to the ground). CVA will guide the changes within the head position to the cervical spine. CVA is a guiding reference for determining FHP, measured CVA ≥52° or even 55.02° ± 2.86° within the normal angle range of the head posture,4 while CVA ≤48° was considered as -malalignment of the head posture- FHP.23

Posture misalignment indicated by CVA was measured by the highly reliable photogrammetric method,27 CVA is used since it is recognized as one of the highly valid angles to distinguish the severity of FHP.28 The photogrammetric method is standardized among all participants by having each person stand sideways to a posture chart on their right side, with a horizontal line drawn on the chart. The participant stands about one foot away from the chart and markers are attached to specific anatomical landmarks, including the 7th cervical vertebra (C7),29 and left side ear tragus; on the inner side of the outer ear. Following localizing the C7 position, its height from the ground was measured and set to the same height as the camera's lens, mobile camera iPhone 7+, 12 megapixels with optical image stabilization is the camera. The camera holder (tripod) was fixedly placed at a distance of 1.5 m away from the left lateral side of each participant's foot, and the feet position was maintained for each participant for the baseline and follow assessments, by feet position printing over A3 plain paper specific for each participant.30

From a neutral individualized standing posture, each participant was asked to move their head in full flexion and extension, then slowly stop at their neutral head position in the most comfortable position.31 Each participant maintain their eye level, with the help of a laser pen, a point was drawn directly in front of the same eye level for each participant.32 Analysis of the capture photographs was processed using SurgiMap Spine software (Massachusetts, USA), which showed its reliability in measuring spinal postural angles.33

To assess neck pain's impact on daily life (secondary outcome), we used the Arabic version of the Neck Disability Index (NDI),34 a validated and reliable questionnaire. This 10-question survey evaluates pain intensity across various aspects of life, including recreation, work, social activities, daily routines, and emotional well-being. A higher NDI score (maximum 50 points, minimum 0 points) indicates greater neck pain severity and difficulty managing daily activities.

2.4

2.4 Statistical analysis

We used SPSS software (version 26.0) to analyze all the data. Figures were created using GraphPad Prism software (version 8.0.2). Descriptive statistics, including means and standard deviations, were calculated for participant demographics (age, height, weight, BMI, average texting time, and average daily sitting time). Unpaired t-tests were used to compare these means between groups.

To ensure reliable analysis, we checked if the data for each group variable followed a normal distribution using the Shapiro-Wilk test. This determined whether we should use parametric tests (for normally distributed data) or non-parametric tests (for non-normally distributed data).

Within-group changes in neck angle (CVA) and disability scores (NDI) were assessed using the Wilcoxon signed-rank test, suitable for paired data. Between-group comparisons were performed using the Mann-Whitney test after calculating the change scores (difference between post-intervention and baseline values) for the experimental group (EG) and control group (CG).

Finally, we used Spearman's rank correlation coefficient to explore the relationship between improvements in neck angle (CVA) and disability scores (NDI). A p-value of less than 0.05 was considered statistically significant.

3

3 Results

3.1

3.1 Descriptive statistics

To ensure originality, we recruited sixty-one healthy individuals over the age of 18 for our study (Fig. 2). Table 1 summarizes the characteristics of the participants, following tests to confirm normal data distribution in both groups. These baseline demographic and clinical characteristics showed no significant differences between the groups. Table 2 presents the changes observed within each group pre- and post-intervention, as well as any differences between the groups.

CONSORT study flow diagram.
Fig. 2 CONSORT study flow diagram.
Table 1 Baseline demographic and clinical characteristics.
Participant Characteristics PCW Orthosis (n = 33) DCF Exercise (n = 28) P value
Age median (years) (Interquartile)* 29.09 (18–53) 29.09 (20–53) 0.99
Gender Male n (%) 20 (60 %) 18 (64 %) 0.77
Female n (%) 13 (39 %) 10 (35 %)
Weight (kg) 69.91 (12.82) 70.39 (11.83) 0.87
Height (cm) 171.1 (9.19) 170.9 (9.46) 0.76
BMI (kg/cm2) 23.70 (3.87) 24.04 (3.22) 0.71
Sitting hours/day 7.94 (2.86) 7.07 (2.35) 0.19
Texting hours/day 2 (5–10) 2 (1–5) 0.59
NDI Score 1 (0–25) 0 (0–21) 0.58
Craniovertebral angle degrees 41.39 (2.97) 43.75 (3.49) 0.32
Table 2 Change between study groups pre-and post-intervention.
Measure Outcomes Within Group Between Groups Mann Whitney Test
PCW Orthosis (n = 33) DCF Exercise (n = 28)
Pretest Median & CI Posttest Median & CI Wilcoxon Signed Rank Test Pretest Median & CI Posttest Median & CI Wilcoxon Signed Rank Test
Mean Rank P Mean Rank P Median Difference P
Craniovertebral angle degrees 42 (40.30–43.00) 51 (49.60–52.10) 17 <0.0001* 45 (42.50–45.90) 47.50 (45.80–48.80) 14.5 <0.0001* 6.90 <0.0001* (5–7.58)
NDI Score 1.0 (0.0–7.0) 0.0 (0.0–0.0) 9.0 <0.0001* 0.0 (0.0–1.0) 0.0 (0.0–0.0) 5.0 <0.0039* −1.0 <0.045* (−7.2 to −1.2)
3.1.1

3.1.1 Effects of the interventions over CVA within experimental vs. control groups

Wilcoxon Signed Rank Test showed a statistically significant difference (Positive value) regarding the degree of CVA improvements, and the change difference for CVA value of pre-and post-intervention of the PCW orthosis group (p < 0.0001), and of the DCF exercise group (p < 0.0001), as presented in as shown in Fig. 3 (A & B).

Mean rank pre- and post-intervention within groups, as represented in box graphs of the Wilcoxon Signed Rank Test. The positive change for CVA degrees for PCW orthosis group (A), DCF exercise group (B), the negative change for NDI score of PCW orthosis group (D), and DCF exercise group (E). Median difference between groups, as represented in the Violin-plot of the Mann Whitney Test. The positive difference in values between groups for CVA degrees (C), and negative difference values for NDI score (F).
Fig. 3 Mean rank pre- and post-intervention within groups, as represented in box graphs of the Wilcoxon Signed Rank Test. The positive change for CVA degrees for PCW orthosis group (A), DCF exercise group (B), the negative change for NDI score of PCW orthosis group (D), and DCF exercise group (E). Median difference between groups, as represented in the Violin-plot of the Mann Whitney Test. The positive difference in values between groups for CVA degrees (C), and negative difference values for NDI score (F).
3.1.2

3.1.2 Effects of the interventions over NDI within experimental vs. control groups

Wilcoxon Signed Rank Test showed a statistically significant difference (Negative value) regarding the score of NDI improvements, as the change difference for NDI of pre-and post-intervention of the PCW orthosis group (p < 0.0001), and of the DCF exercise group (p = 0.0039), as presented in Fig. 3 (D & E).

3.1.3

3.1.3 Comparing interventions difference between experimental vs. control groups

Mann–Whitney Test, showed a statistically significant difference between both groups for CV angle improvement (p < 0.0001), and NDI improvement (p = 0.045), as presented in Fig. 3 (C & F).

3.1.4

3.1.4 Correlation between CVA and NDI improvements within groups

Spearman test -correlation coefficient (r)- to examine the correlation between CV angle and NDI scores improvements, showed no correlation within the PCW orthosis group (r = 0.129, p = 0.473), CI (−0.23 to 0.46), and within the DCF exercise group (r = 0.073, p = 0.71), CI (−0.31 to 0.44).

4

4 Discussion

Our study provides evidence indicating apart from the currently used wide range of exercises (Stretching, strengthening, manipulation, mobilization, resistance, etc.),21,23,25 another innovative maneuver by considering posterior cervical weighting orthosis (PCWO) is useful in correcting FHP. The new and innovative aspects of our study showed that FHP is corrected by PCWO and it was more effective than the conventional protocol of deep cervical flexion (DCF) exercises.25 Our results were consistent with the previous studies that implemented DCF exercises,23,25 however, to our knowledge, no study considered attaching an external posterior weight to correct FHP. Despite this, a case report has shown a positive effect of the anterior head-weight device following manipulative therapy on cervical lordotic curve restoration and FHP correction,35 and the immediate effect of the anterior head-weight device has been investigated in a larger population, revealed reduction of cervical lordosis.21 The authors of another study combined an anterior head-weight device with the proprioceptive training exercise, and the study results showed an appropriate effect.36 While the authors did report improvements, it's essential to note that the immediate effects observed could be influenced by various factors. For instance, participants in that study were seated on a wobble chair while wearing the weight, which could have contributed to the observed outcomes.36

In contrast, another study involved a case report where the author employed a comprehensive management plan, combining conventional interventions such as cervical traction and mobilization alongside the use of the ant head weight device. This integrated approach could have synergistic effects on correcting FHP.35

In our study, however, we focused solely on assessing the effects of posterior head weighting without incorporating additional interventions. By isolating the impact of this specific intervention, we aimed to provide a clearer understanding of its efficacy in addressing FHP.

The mechanism of action of the anterior head weight device was hypothesized that the device could cause the body's righting reflexes to react and that would positively reflect on posture correction to its ideal status.36

A possible explanation of the posterior cervical weighting mechanism of action is raised from the cervical spine serves as a lever arm attachment, since the 1st class lever system is well defined by the head position residing over the cervical spine, the more head translates anteriorly in the sagittal plane relative to the neck, the more the effort exerted by antigravity components of the neck posterior elements to balance against the increasing anterior load, so it could be defined as the following; the posterior elements effort represented by the force (F), and the anterior load of the head represented by the resistance (R).37 PCW orthosis hypothesized in rebalancing the head position could be associated with shifting the muscles activity from superficial to deep neck muscle. This theoretical explanation should be supported by electromyographical evaluation to objectively reveal the changes within muscle imbalance of extrinsic (superficial) and intrinsic (deep) extensors of the cervical.38 Another finding of the current study finds no correlation between CV angle changes and NDI score, this is not consistent with the other findings of the systematic review.10 However, there both experimental and control groups showed improved pain intensity assessed by the NDI scale, which is consistent with another study's findings.25

Strengths of the current study include the following, first, to our knowledge, this is the first study to consider the novel and innovative PCWO as an external weight for FHP correction.

Second, this study showed the superior effect of PCWO over DCF exercise for improving CVA and reducing neck disability. Third, this study is a promising intervention of implementing external weighing for different spinal posture deformities such as scoliosis, kyphosis, etc.

The limitations of this study are as the following. First, the long-lasting effect of PCWO was not assessed, and it is recommended to be considered in future studies. Second, the external weight (2 Kg) was constant for all of the participants, despite different FHP severity according to CVA. The weight value was inspired by approximate weight values used in a previous study which fitted participants with weight values ranging from three to five pounds,36 therefore, further studies should consider individualizing the weight value according to the FHP severity.

5

5 Conclusion

The use of an orthosis in clinical practice as a stand-alone treatment is not consistent with current clinical practice guidelines for treatment of neck pain. Finally, PCWO is a novel and innovative neck orthosis that is considered a promising intervention to correct FHP and improve correlated neck disability.

Funding

No funding was received for this research.

Ethical statement

This study was approved by the ethics committee of Faculty of Medicine Alexandria University (approval number: 0305072).

Conflict of interest

The authors declare no conflicts of interest, financial or non-financial.

Patient consent

Patient consent has been obtained.

CRediT authorship contribution statement

Hussein Youssef: Conceptualization, Methodology, software, formal analysis, Visualization, Writing – original draft, Writing – review & editing. Osama Ragaa: Supervision, Investigation, Resources, Writing – review & editing.

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