Rigid Cervical Collars after Posterior Cervical Fusion: Do They Improve Outcomes? A Randomized Clinical Trial

Abstract

Objective

To evaluate whether the postoperative use of a rigid cervical collar after posterior cervical decompression and fusion (PCDF) improves neck pain, functional disability, and quality of life in patients with degenerative cervical myelopathy (DCM).

Materials and Methods

A single-blind, randomized controlled trial was conducted involving 60 adult patients with magnetic resonance imaging–confirmed DCM undergoing PCDF at two tertiary centers. Participants were randomly assigned to either a rigid cervical collar group (n = 30) or a no-collar group (n = 30) postoperatively. Outcomes were measured at 1, 3, 6, and 12 months postsurgery.

Statistical Analysis

The primary outcome was axial neck pain at 1 month, measured by the visual analog scale (VAS). Secondary outcomes included the neck disability index (NDI) and the 36-Item Short Form Survey (SF-36). Statistical tests included paired t-tests, Mann–Whitney's U tests, and repeated-measures analysis of variance, with all data analysis performed by investigators blinded to group allocation. Post hoc power analysis was conducted to assess statistical sensitivity.

Results

Both groups experienced significant improvements in VAS, NDI, and SF-36 scores over time. However, there were no statistically significant differences between the collar and no-collar groups at any measured time point. At 1 month, mean VAS scores were 4.30 ± 0.75 (collar) and 4.07 ± 0.58 (no collar; p = 0.233). Gains in disability and quality-of-life measures surpassed minimal clinically important differences for both groups, but without significant between-group differences. The trial was underpowered (post hoc power = 26.4%) to detect small-to-moderate differences; therefore, outcomes should be interpreted cautiously.

Conclusion

The use of a rigid cervical collar after PCDF did not confer additional benefit for neck pain, functional outcomes, or quality of life compared with no collar. These findings suggest that routine rigid cervical collar prescription after PCDF should be reconsidered. Given the study's limited statistical power (26.4%) and lack of surgeon/patient blinding, findings should be interpreted cautiously.

Keywords

cervical collar - myelopathy - cervical fusion - neck pain - functional outcome

Introduction

Background

Posterior cervical decompression and fusion (PCDF) is a well-established surgical approach for managing various spinal pathologies. With the global rise in the geriatric population, the demand for cervical arthrodesis procedures, including PCDF, has steadily increased over recent decades.[1] [2] Multiple surgical techniques may be employed to achieve posterior cervical fusion (PCF), such as wiring, rod-and-screw constructs, and minimally invasive methods. The choice of approach typically depends on the patient's underlying pathology and anatomical considerations.[3] [4] PCDF has consistently demonstrated favorable clinical outcomes, with reported fusion success rates as high as 98.25%, along with marked improvements in arm and neck pain and disability scores, as measured by the visual analog scale (VAS), neck disability index (NDI), and the Japanese Orthopedic Association scale.[5] [6]

Rationale and Knowledge Gap

Rigid cervical orthoses, including cervical collars, are frequently prescribed following cervical spine surgery with the intent of immobilizing the neck and enhancing postoperative spinal stability.[7] While their utility is well established in managing cervical trauma, the benefit of postoperative collar use in elective cervical spine surgeries remains uncertain. Current evidence does not clearly support the hypothesis that cervical collars reduce fixation failure rates postoperatively.[8] Similarly, their effectiveness in alleviating postoperative neck pain is questionable. For example, Fernandes et al found no significant difference in pain scores at 4 weeks between patients who wore cervical collars and those who did not following multilevel PCF.[8] [9] Additionally, Khadivi et al reported that patients who did not use cervical orthoses demonstrated improved quality of life at 3 months postoperatively.[10] Despite the lack of strong and consistent evidence, the routine prescription of cervical collars persists in clinical practice, often in the absence of high-quality randomized trials. The absence of definitive guidelines and the continued reliance on collars underscore the need for further investigation.

Objective

The objective of this study was to evaluate the effectiveness of rigid cervical collar use compared with no collar in enhancing postoperative outcomes, including neck pain, functional disability, and health-related quality of life, among adults undergoing PCDF for degenerative cervical myelopathy (DCM). The study aims to provide high-quality evidence from a randomized controlled trial to inform postoperative management practices for this patient population.

Materials and Methods

Study Design

This was a randomized, parallel-group, single-blind clinical trial, with blinding applied at the level of statistical analysis. The study was conducted between 2022 and 2024 at two academic tertiary care centers. Ethical approval was obtained from the Institutional Review Board (IR.TUMS.SHARIATI.REC.1402.132). All patients were given a detailed explanation of the study protocol and provided written informed consent before enrollment. Eligible patients undergoing PCDF were randomly assigned in a 1:1 ratio to either a rigid cervical collar group or a no-collar group.

Participants

Participants were adults aged 18 years or older scheduled for PCDF due to DCM, confirmed by magnetic resonance imaging (MRI). Surgeries involved fusion across a minimum of two and a maximum of five vertebral levels between C3 and C7. Key exclusion criteria included satisfactory response to nonsurgical management, traumatic spinal injuries, neoplastic or infectious spinal pathology, inflammatory spondylopathies, high-grade (grade 3 or 4) spondylolisthesis, combined cervical and lumbar canal surgeries, revision procedures, contraindications to MRI, pregnancy, osteoporosis, severe psychiatric illness, or unwillingness to participate. All eligible patients were enrolled consecutively from the participating hospitals. The study enrollment and randomization process are presented in the CONSORT flow diagram.[11]

Sample Size

A total of 60 patients were enrolled, with 30 patients in each group. The sample size was calculated to detect a clinically meaningful difference of 1.2 points in the primary outcome (VAS score) between groups, assuming a variance of 2 points, 80% power, a two-sided α of 0.05, and a 95% confidence interval.[12]

Randomization and Blinding

Block randomization with block sizes of six was used to ensure balanced allocation between groups. Due to the nature of the intervention, neither patients nor surgeons were blinded. However, outcome data were analyzed in a blinded fashion to minimize potential bias.

Interventions

All patients underwent PCDF using rod-and-screw constructs with lateral mass fixation.[10] Patients in the collar group were fitted with a rigid cervical collar sized individually (small, medium, or large) and instructed to wear it continuously for 3 months postoperatively, except during sleep. Rigid collars were prescribed for 3 months following institutional protocol supported by prior 8- to 12-week use in published PCDF studies.[10] [13] Patients in the no-collar group received standard postoperative care without a cervical orthosis. Both groups followed uniform postoperative pain management and rehabilitation protocols.[13]

Outcomes

The primary outcome was axial neck pain, assessed using the VAS at 1 month postoperatively, chosen to capture the early recovery period and assess potential differences between groups. Secondary outcomes included the NDI[13] and the 36-Item Short Form Survey (SF-36),[14] recorded at baseline and at 1, 3, 6, and 12 months postsurgery. All outcomes were patient-reported and collected during routine follow-up visits using validated instruments.

Statistical Methods

All statistical analyses were conducted using SPSS version 26 (IBM Corp., Chicago, Illinois, United States). The Shapiro–Wilk's test was used to assess the normality of continuous variables. For data following a normal distribution, independent t-tests were employed to compare group means. For nonnormally distributed variables, the Mann–Whitney's U test was used. Categorical variables were analyzed using chi-square/Fisher's exact test, and correlations between numerical variables were examined using Spearman's correlation coefficient. To assess differences over time between groups, repeated-measures analysis of variance and analysis of covariance were utilized. Continuous variables are presented as mean ± standard deviation. A p-value of less than 0.05 was considered statistically significant.

Results

Between 2022 and 2024, a total of 87 patients were screened for eligibility across two tertiary care hospitals. Of these, 27 patients were excluded: 10 did not meet the inclusion criteria (e.g., adequate response to nonsurgical treatments, presence of vertebral fractures, tumors, or infections), 13 declined participation and did not provide written informed consent, and 4 were excluded for other reasons. Ultimately, 60 patients were enrolled and randomized in a 1:1 ratio into the collar group (n = 30) and the no-collar group (n = 30) using block randomization. All participants completed the study without any dropouts or loss to follow-up and were included in the final analysis ([Fig. 1]).

Fig. 1 CONSORT flow diagram of patient enrollment, randomization, allocation, follow-up, and analysis.

Baseline Characteristics

Baseline demographic and surgical characteristics were well balanced between the two groups, confirming successful randomization ([Table 1]). There were no statistically significant differences between groups in mean age, body mass index, gender distribution, number of fused segments, or smoking status.

Table 1 Baseline demographic characteristics of patients

	Collar group (n = 30)	No-collar group (n = 30)	p-Value
Age (mean, SD)	47.7, 17.2	46.4, 17.6	0.722
BMI (mean, SD)	26.5, 3.3	27.2, 3.4	0.558
Gender (female:male)	16:14	15:15	0.796
Smoker	8	4	0.197
Fused level numbers
Three levels	2	0	0.051
Four levels	26	22
Five levels	2	8

Abbreviations: BMI, body mass index; SD, standard deviation.

Primary Outcome

The primary outcome, axial neck pain assessed using the VAS at 1 month postoperatively, showed no significant difference between the two groups. The mean VAS score was 4.30 ± 0.75 in the collar group and 4.07 ± 0.58 in the no-collar group (p = 0.233) ([Table 2]).

Table 2 Clinical outcomes for neck pain and quality-of-life measurements

	Collar group (n = 30)	No-collar group (n = 30)	p-Value
Axial pain VAS (mean, SD)
Preoperative	5.17, 1.02	5.00, 0.87	0.580
1-mo postoperative	4.30, 0.75	4.07, 0.58	0.233
3-mopostoperative	2.70, 0.47	2.53, 0.51	0.188
6-mo postoperative	1.47, 0.51	1.47, 0.51	0.999
1-ypostoperative	1.27, 0.45	1.23, 0.43	0.767
NDI (mean, SD)
Preoperative	49.27, 3.40	48.43, 3.18	0.388
1-mo postoperative	48.49, 3.35	48.81, 3.11	0.623
3-mo postoperative	38.89, 4.26	38.45, 3.71	0.835
6-mopostoperative	30.87, 6.82	31.01, 7.04	0.953
1-y postoperative	25.16, 1.24	25.25, 1.07	0.659
SF-36 (mean, SD)
Preoperative	38.82, 4.26	38.19, 3.35	0.761
1-mo postoperative	48.17, 3.20	48.33, 3.15	0.737
3-mo postoperative	50.68, 3.83	49.84, 4.13	0.368
6-mo postoperative	61.88, 1.04	61.82, 1.07	0.812
1-y postoperative	73.72, 1.76	73.61, 1.76	0.783
SF-36, PCS (mean, SD)
Preoperative	14.01, 2.13	13.69, 1.67	0.758
1-mo postoperative	18.69, 1.6	18.77, 1.57	0.737
3-mo postoperative	19.94, 1.92	19.52, 2.06	0.370
6-mo postoperative	25.54, 0.52	25.51, 0.53	0.812
1-y postoperative	31.46, 0.88	31.42, 0,83	0.783
SF-36, MCS (mean, SD)
Preoperative	24.81, 2.13	24.49, 1.67	0.760
1-mo postoperative	29.49, 1.6	29.57, 1.57	0.741
3-mo postoperative	30.74,1.92	30.32, 2.06	0.364
6-mo postoperative	36.34, 0.52	36.31, 0.53	0.812
1-y postoperative	42.26, 0.88	42.22, 0.83	0.783

Abbreviations: MCS, mental component score; NDI, neck disability index; PCS, physical component score; SD, standard deviation; SF-36, 36-Item Short Form Health Survey; VAS, visual analogue scale.

Secondary Outcomes

Both groups exhibited significant within-group improvements in VAS, NDI, and SF-36 scores over time. In the collar group, mean VAS scores decreased from 5.17 ± 1.02 preoperatively to 1.27 ± 0.45 at 1 year. In the no-collar group, VAS scores improved from 5.00 ± 0.87 to 1.23 ± 0.43 over the same period.

NDI scores declined from 49.27 ± 3.40 to 25.16 ± 1.24 in the collar group, and from 48.43 ± 3.18 to 25.25 ± 1.07 in the no-collar group. Similarly, SF-36 scores increased from 38.82 ± 4.26 to 73.72 ± 1.76 in the collar group, and from 38.19 ± 3.35 to 73.61 ± 1.76 in the no-collar group.

Despite these meaningful improvements within both groups, there were no statistically significant differences between the collar and no-collar groups at any postoperative time point (1, 3, 6, or 12 months) for VAS, NDI, or SF-36 scores (all p > 0.05; [Table 2]).

Post hoc Power Analysis

A post hoc power analysis was performed for the primary outcome (VAS at 1 month postoperatively). Based on the observed effect size (Cohen's d = 0.34), the calculated power of the study was 26.4% at an α level of 0.05. This indicates the study had limited power to detect small-to-moderate between-group differences.

Discussion

Key Findings

This randomized controlled trial was designed to evaluate the clinical effectiveness of postoperative rigid cervical collar use following PCDF in patients with DCM, confirmed by MRI. We compared outcomes between 30 patients allocated to a cervical collar group and 30 patients in a no-collar group. The primary outcome—axial neck pain measured by VAS at 1 month postoperatively—showed no statistically significant difference between groups (collar group: 4.30 ± 0.75; no-collar group: 4.07 ± 0.58; p = 0.233). Secondary outcomes, including VAS scores at 3, 6, and 12 months, as well as NDI and SF-36 scores, also demonstrated marked improvements within both groups over time, but no statistically significant differences were found between the two interventions at any time point ([Tables 1] and [2]; all p > 0.05). These findings suggest that the use of a cervical collar after PCDF does not provide additional benefit in reducing neck pain, improving neck-specific disability, or enhancing overall quality of life.

One notable aspect of our findings is that both groups achieved clinically meaningful improvements in NDI scores, surpassing the minimal clinically important difference of 10.5 points.[15] The NDI improved from 49.27 ± 3.40 to 25.16 ± 1.24 in the collar group and from 48.43 ± 3.18 to 25.25 ± 1.07 in the no-collar group, demonstrating substantial recovery regardless of collar use. Similarly, SF-36 scores increased comparably in both groups (collar group: from 38.82 ± 4.26 to 73.72 ± 1.76; no-collar group: from 38.19 ± 3.35 to 73.61 ± 1.76), reflecting significant improvement in health-related quality of life. The strong correlation between NDI and SF-36 reported in the literature (r = −0.848, p = 0.001)[16] aligns with the parallel trajectories observed in our cohort. Collectively, these results suggest that the clinical benefits of PCDF are robust and largely unaffected by the use of postoperative cervical collars.

An additional observation was a near-significant imbalance in the number of patients undergoing five-level fusion, with more cases in the no-collar group (eight patients) compared with the collar group (two patients; p = 0.051). While this difference did not reach statistical significance, it may indicate a slightly higher surgical complexity in the no-collar group. Prior studies have suggested that increased numbers of fused levels may be associated with longer recovery or increased complication rates.[17] Despite this imbalance, we found no between-group differences in outcomes, further reinforcing the limited role of collars in influencing recovery following PCDF.

Comparison with Similar Research

Our findings are consistent with several prior randomized controlled trials investigating postoperative cervical collar use ([Table 3]). Fernandes et al[17] conducted a randomized controlled trial evaluating cervical orthoses after multilevel PCF, finding no significant differences in neck pain (as measured by the numerical pain rating scale), NDI, SF-12 physical and mental component scores, narcotic use, or patient satisfaction between groups. Adverse event rates were also comparable. Like our study, their findings do not support routine cervical orthosis use for pain relief or functional improvement post-PCF.

Table 3 Literature review for randomized trials for cervical collar after CF surgery

First author (year), country	Surgical procedure	Blinding and randomization	Sample size	Main results
Abbott et al. (2013), Sweden[18]	Anterior cervical discectomy and fusion	No-blinding, randomized	33 (17 with collar, 16 without collar)	• Rigid cervical collars significantly reduced neck disability and pain at week 6 of follow-up • No significant between-group differences in terms of QoL, fusion rate, CROM, or balance • A collar may help patients with postsurgical recovery
Fernandes et al (2024), Canada[17]	Posterior CF	No-blinding, randomized	62 (31 with cervical orthosis, 31 no orthosis)	• Pain scores at week 6 follow-up revealed a statistically insignificant difference between groups • NDI, arm pain, narcotic use, satisfaction with treatment, and QoL scores between the intervention groups were similarly insignificant • The orthosis group had reduced CROM at week 6 of follow-up • Adverse event rates were similar
Hida et al (2017), Japan[19]	Cervical laminoplasty	Randomized, blinded (outcome assessors, not patients or surgeons)	90 (45 CF, 45 NC) 74 with 1-y follow-up (39 collar, 35 NC)	• No significant difference in terms of neck pain between the intervention groups • No significant difference between the complication rates of the CF and NC groups

Abbreviations: CF, cervical fusion; CROM, cervical range of motion; NC, no collar; NDI, neck disability index; QoL, quality of life.

In contrast, Abbott et al[18] conducted a pilot randomized controlled trial assessing collar use after anterior cervical discectomy and fusion. They reported some early differences favoring collar use, particularly in 6-week NDI and 12-month SF-36 social functioning and selected subdomains. However, their study had a small sample size (n = 33), and the authors noted the need for a larger cohort to confirm findings. Furthermore, differences in surgical approach (anterior vs. posterior) and patient population limit direct comparability with our study. Notably, many of their secondary outcomes, including radiographic fusion rates, were similar across groups, mirroring our results.

Hida et al[19] evaluated collar use following cervical laminoplasty and found no significant differences between collar and no-collar groups in VAS scores, JOA scores, SF-36, or cervical range of motion. Despite the procedural differences (laminoplasty vs. PCDF), their results, consistent with ours, challenge the notion that cervical collars improve pain control or functional outcomes postoperatively.

Implications and Actions Needed

The rationale for prescribing rigid cervical collars postoperatively is based on the theoretical benefit of motion restriction, fusion promotion, pain reduction, and psychological reassurance. However, a recent systematic review concluded that there is insufficient evidence to support these assumptions.[7] Furthermore, prolonged collar use may introduce additional risks, including pressure ulcers, dysphagia, delirium, elevated intracranial pressure, respiratory infections, reduced cervical mobility, falls, pneumonia, and psychosocial challenges such as emotional distress or low self-esteem.[7] [20] [21] Given the absence of demonstrated benefit and the potential for harm, routine postoperative collar use after PCDF warrants re-evaluation.

While rigid collars aim to provide maximal immobilization, soft collars may serve primarily for comfort and psychological reassurance. Evidence suggests that soft collars afford equivalent outcomes in pain control and function compared with rigid braces, with improved tolerance and fewer complications.[7] [12] Therefore, their selective use may be reasonable when patient comfort is a concern.

Strengths and Limitations

Our study has several strengths. It was designed as a randomized controlled trial with balanced groups, 1-year follow-up, and use of validated, patient-centered outcome measures (VAS, NDI, and SF-36). Statistical analyses were performed under blinded conditions, reducing the risk of bias. To our knowledge, this is among the first randomized trials examining cervical collar use after PCDF with blinded analysis. However, limitations should be acknowledged. The absence of surgeon and patient blinding may lead to perception bias in subjective measures such as VAS, NDI, and SF-36. Moreover, the study's conduct at two tertiary centers within a single country limits external validity. Larger, multicenter trials are needed to validate these results. Our post hoc power analysis revealed low statistical power (26.4%) to detect small-to-moderate effect sizes, increasing the risk of type II error. Future research with larger, multicenter cohorts is needed to validate these findings and shape clinical practice. Additionally, long-term studies could help assess whether collars have delayed effects on fusion rates or late complications.

Conclusion

In summary, our randomized controlled trial found no significant differences in neck pain, disability, or quality of life between patients treated with or without a cervical collar following PCDF. Both groups experienced substantial improvements across all outcomes, indicating that the success of PCDF is not dependent on the adjunctive use of rigid cervical collars. Given the study's limited statistical power (26.4%) and lack of surgeon/patient blinding, findings should be interpreted cautiously. Nonetheless, the trial reinforces that postoperative collar use, whether rigid or soft, may not materially influence recovery after PCDF. Future multicenter randomized studies are necessary to confirm these observations.

Conflict of Interest

None declared.

Authors' Contribution

The conception and design of the study were performed by A.H., M.R., and M.F.J. Administrative support was provided by M.R. A.H., M.R., and F.R. handled study materials and patient recruitment, also contributing to data collection and assembly. Data analysis and interpretation were performed by A.H., S.B., M.S., and A.P. The manuscript was written by A.K., M.T.R., S.B., M.R., D.S.R., and D.S. Critical revision was performed by P.A., M.G., and M.R. All authors gave final approval of the manuscript.

Ethical Approval

We obtained ethical approval for this study from the Shariati Hospital Ethics Committee under protocol code IR.TUMS.SHARIATI.REC.1402.132.

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Publikationsverlauf

Artikel online veröffentlicht:
29. Dezember 2025