Visual abstract

Introduction

Cervical disc herniation (CDH) is a condition where the nucleus pulposus of an intervertebral disc in the cervical spine protrudes causing pain and this frequently leads to cervical radiculopathy due to compression of nearby spinal nerves [1]. While the etiology of CDH is complex, it is more commonly chronic due to the aging process rather than acute traumatic injury [2]. The incidence of CDH, in a study performed in Minnesota, was 83.2 per 100,000 individuals, with the highest incidence in those in their 50s [3].

Conservative treatment is primarily recommended for CDH however, if symptoms do not improve minimally invasive procedures such as nerve block or nucleoplasty are available, but if these are ineffective, surgeries such as diskectomy, osteophyte removal, and fusion surgery may be considered [2]. CDH surgery can result in adverse effects such as nerve damage and degenerative changes in adjacent segments and studies have shown no difference in long-term benefits between surgical and nonsurgical approaches [4,5]. Long-term follow-up studies of CDH patients who received nonsurgical management, including medication and physical therapy, have revealed sustained significant improvement [2,6,7]. Although these studies are often old, few in number, and limited in the quality [8].

Korean medicine offers a representative nonsurgical approach to treatment of CDH and is widely utilized in clinical practice (e.g., acupuncture, pharmacopuncture, herbal medicine, and Chuna therapy). In the 2023 National Health Insurance Statistical Yearbook in Korea, CDH was attributable to 253 billion South Korean won in medical care benefits, ranking 19th for inpatient and 31^st for outpatient care in Korean medicine, indicating a high demand for Korean medicine treatment for this condition [9]. Despite this, previous studies analyzing the effectiveness of integrative Korean medicine (iKM) treatment for CDH have been limited to retrospective medical record analyses confirming treatment efficacy [10–14] and only 1 prospective long-term follow-up study of hospitalized patients [15]. Therefore, this current study aimed to prospectively evaluate the effectiveness and safety of iKM treatment for CDH presenting with radiculopathy, by individually following up with outpatients, and reflecting real-world clinical practice.

Materials and Methods

1. Study design and procedures

This was a prospective, single-arm, multi-center, observational study. From July 2019 to December 2021, 120 patients were recruited through in-hospital and external advertisements at Jaseng Hospital of Korean Medicine in 4 regions (Seoul, Daejeon, Bucheon, and Busan) in Korea. Patients diagnosed with CDH (with protrusion or more severe conditions) via magnetic resonance imaging (MRI), and presenting with radiculopathy, received iKM treatment for approximately 2 months after screening. During the treatment period, they were assessed for pain, functional disability, and quality of life every 2 weeks. Follow-up evaluations were conducted via telephone or in-person visits.

This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Jaseng Hospital of Korean Medicine in South Korea (approval no.: JASENG 2019-04-009, JASENG 2019-04-010, JASENG 2019-04-011, and JASENG 2019-04-013). Informed consent was obtained from all participants prior to their participation in the study. This study protocol was registered at ClinicalTrials.gov (no.: NCT03959098) and cris.nih.go.kr (no.: KCT0004158).

2. Participants

Patients received a thorough explanation of the study prior to participation and voluntarily provided written informed consent. The study included patients aged 19–65 years with CDH confirmed by MRI, presenting with neck and radicular upper extremity pain [numeric rating scale (NRS) ≥ 6] of recent onset within the last 12 months. Exclusion criteria barred patients with a history of CDH surgery, myelopathy, other conditions not related to the spinal or systemic disease that could confound results (e.g., tumors, rheumatoid arthritis), or contraindications to acupuncture. The specific criteria were on the protocol registration site.

3. Interventions

As an observational study, treatments had no specific restrictions beyond adherence to the inclusion/exclusion criteria. However, the methods of treatments were generally carried out according to the hospital’s standard protocols and the type and frequency of treatments were recorded in the hospital’s electronic medical record system. Patients were permitted to continue their existing treatments or receive new treatments, including Western medicine if needed, and the status of such healthcare utilization was investigated throughout the study period.

3.1. Korean medicine treatment protocol

Herbal medicine was taken 2–3 times/day in the form of a pill and water-based decoction form (main herbs: Acanthopanax sessiliflorus, Eucommia ulmoides, Saposhnikovia divaricata, Achyranthes bidentata, Cibotium barometz, and Glycine max). These main herbs are traditionally widely used for musculoskeletal disorders [16], and additional herbs were supplemented based on the patient’s disease severity, digestive status, and overall condition. Acupuncture was administered 1–2 sessions/day at acupuncture points related to neck pain. Electroacupuncture was also used to increase the effect. Pharmacopuncture was administered 1 session/day at cervical Hyeopcheok (Huatuo Jiaji, EX-B2) and Ashi points using disposable injection needles (CPL Co., Ltd., 1 cc, 26G × 1.5 syringe; Shinchang Medical Co. in Korea). Chuna therapy, a Korean manipulation method that combines conventional manipulation techniques to joints slightly beyond the passive range of motion (ROM), and manual force within the passive range, was conducted.

4. Outcomes

All outcome variables were assessed by Korean medicine doctors who were not the treating physician and who had received training on the tools used for outcome measures.

The primary outcome was reduction in neck or upper extremity pain as measured using the NRS tool, which rates pain from 0 (no pain) to 10 (worst imaginable pain). The pain intensity of the neck and upper extremity was investigated, with the baseline level of pain, before integrative treatment, being used as the reference.

Secondary outcome measures included pain affecting daily life activities, disability, improvement and productivity, and quality of life which were assessed using scores from: (1) the visual analogue scale (VAS) for neck and arm pain, on which pain intensity is marked along a 0–100 mm line; (2) the neck disability index (NDI) [17] which assesses cervical spine-related functional disability; (3) the patient global impression of change, a 7-point scale for evaluating the overall degree of improvement; (4) the EuroQol-5-dimension (EQ-5D) [18], for assessing health-related quality of life; (5) the work productivity and activity impairment questionnaire (WPAI) [19], which evaluates productivity loss; (6) the ROM test, for assessing cervical ROM; and (7) a survey on healthcare utilization patterns regarding both Korean medicine and Western medicine treatments received. Among the EQ-5D instruments the EQ-5D-5L format was used to evaluate function across 5 dimensions (mobility, self-care, usual activities, pain, and anxiety) on a 5-level scale, and the EQ-VAS, a 100 mm line on which patients recorded their perceived health status. In addition, a Korean medicine doctor assessed ROM by measuring the angles of the cervical spine for flexion, extension, lateroflexion, and rotation. The WPAI Version 2.0 Korea was used specifically for general health [20], and the scores were multiplied by 100 for convenience. The WPAI was measured using a narrow estimate, which considered only the productivity loss of paid workers, and a broad estimate, which included all nonworking populations (Supplementary Table 1).

5. Safety assessment

Safety was assessed by the frequency of adverse events. The investigators recorded all unintended events in patients, including serious adverse events. The causality of adverse events was evaluated using a 6-point scale (1 = definitely related, 2 = probably related, 3 = possibly related, 4 = probably not related, 5 = definitely not related, and 6 = unknown). All adverse events were categorized into 3 grades (mild, moderate, severe) according to the Spilker classification.

6. Statistical analysis

In this study, the primary and secondary outcome variables were analyzed using a linear mixed model (LMM) to assess changes from baseline to each time point. In the LMM, time and baseline outcomes were included as fixed effects, and a patient-specific random intercept was included to account for repeated measurements within the same patient. In addition, sensitivity analysis was performed using repeated measures analysis of variance after handling missing values with multiple imputation sets. Continuous variables were presented as mean and standard deviation, while categorical variables were presented as frequency (%). All statistical analyses were conducted using SAS Version 9.1.3 statistical package (SAS Institute, Cary, NC, USA) or R software (Version 4.1.3; R Foundation for Statistical Computing, Vienna, Austria), and statistical significance was set at p < 0.05.

Results

1. Patients

There were 120 patients who were recruited from July 2019 to December 2021. One patient withdrew consent prior to receiving treatment. During the 2-month treatment period, 4 patients dropped out. In total there were 115 patients who completed the intervention treatment. Subsequently, 114 patients were included at the 1-year follow-up (Figure 1). Among these, patients who had in-person follow-up visits underwent additional physical examinations like ROM tests and VAS scoring.

The demographic characteristics of the patients, and baseline scores are summarized in Table 1 and the key baseline characteristics for each institution are provided in Supplementary Table 2. Various occupations were represented, with 79 patients (66.39%) who were currently employed. The primary outcome tool, NRS, showed an average baseline score of 7.3 ± 0.9, indicating a severe level of pain. Regarding MRI findings at the time of study enrollment, protrusion was the most common finding, with C5-6 and C4-5 being the most frequently affected segments.

2. Interventions

The electronic medical record system showed that during the study’s intervention treatment period all patients received acupuncture and pharmacopuncture therapy. The main types of pharmacopuncture and herbal medicine prescriptions were largely consistent with the intervention protocol, suggesting that treatment heterogeneity was not substantial (Table 2). However, 31 patients also received additional herbal medicine prescriptions in the outpatient setting for other symptoms or conditions, though these were typically temporary dyspepsia or musculoskeletal prescriptions related to shoulder pain. The average number of treatment visits was 15.35±4.45 over 2 months, indicating that patients received treatment approximately twice weekly.

3. Outcomes

The values for all outcomes at each time point, derived from the LMM analysis, are presented in Table 3 for the treatment period and Table 4 for the follow-up period. The primary outcome to reduce neck and upper extremity pain following treatment was measured using the NRS, at baseline, during treatment and at follow-up as per the protocol. The scores gradually decreased during the treatment period, improving by more than 50% from baseline to completion at 8-weeks post treatment. This statistically significant improvement was maintained at a similar level at 12 weeks, 24 weeks, and 1 year (Figure 2). Among the patients, a higher prevalence of neck pain was observed; there were 74 patients with neck pain, and 45 patients with arm pain. In a subgroup analysis where the groups were separated, both subgroups showed statistically significant decreases in pain from baseline at all time points, consistent with the main LMM analysis (p < 0.001; Supplementary Table 3). Other pain assessment tools, such as VAS revealed scores for both neck and arm pain which were similar to the NRS findings.

Quality of life and function-related outcomes, including scores from the EQ-VAS, EQ-5D-5L, and NDI, also showed a continuous improvement from baseline until Weeks 8–12, which were maintained at the 1-year follow-up. In the WPAI questionnaire, both a narrow estimate and a broad estimate showed a statistically significant decrease in scores compared with the baseline. The patient global impression of change, which reflects the overall degree of improvement, indicated “very much improved” at the Week 8 after treatment. The sensitivity analysis, using repeated measures analysis of variance with multiple imputation sets, presented in Supplementary Table 4, showed statistically significant improvements, from baseline to the completion of treatment, for all tools, similar to the primary analysis.

The use of healthcare services for CDH is shown in Table 5. Regarding Western injection therapy, 21 patients received treatment >12 months prior to the study, while 4 received it at baseline, 1 during the treatment period, and 4 during the 1-year follow-up period. The majority of patients received physical therapy prior to the study (n = 41), at baseline there were 8 patients, during treatment there were 12, and at follow-up 7 patients had received physical therapy. Patients receiving physical therapy during the treatment period did so concomitantly with Korean medicine treatment at our hospital. While 36 patients had taken conventional Western medications such as analgesics previously, and 12 at baseline, only 2 continued to receive repeat prescriptions during study and at the follow-up.

4. Safety

Safety was assessed by the adverse events recorded at all visits and during follow-up. During the entire 1-year follow-up period, a total of 118 adverse events were confirmed in 69 patients. Of the 118 events, the causality assessment with the intervention revealed that 15 cases (12.71%) were “possibly related,” 6 cases (5.08%) were “probably related,” and 0 cases were “definitely related.” These 21 related events were mostly mild, such as headache or diarrhea, and all patients recovered without any specific action or with medication. There were 8 serious adverse events in 7 patients, most of which were unintended events unrelated to the intervention, such as hospitalizations due to a traffic accident or contraction of herpes zoster. Only 2 of these events involved hospitalization at a Western medicine hospital for worsening neck pain. After receiving analgesics and injection therapy, these patients recovered, were discharged, and are still currently undergoing follow-up observation (Supplementary Table 5).

Discussion

This prospective study involved the long-term follow-up of patients with CDH and radiculopathy receiving iKM treatment. The evaluation of effectiveness and safety at the 1-year follow-up revealed statistically and clinically significant improvements from baseline not only in pain indicators but also in measures reflecting function and quality of life. These findings may suggest that iKM can be proposed as an effective conservative treatment option for CDH.

Regarding the primary outcome, reduced pain in the neck and upper extremities, using the NRS, a mean decrease in score of 2.70 (95% CI, 2.38 to 3.02) was observed from baseline to Week 4. This reduction was sustained and even became more pronounced, demonstrating a long-term therapeutic effect with a value of 4.42 (95% CI, 4.09 to 4.75) at the 1-year follow-up. Considering that the minimal clinically important difference (MCID) for neck pain after cervical surgery was 2.5 [21], it can be inferred that a clinically significant improvement was achieved as early as Week 4. In a retrospective analysis of CDH patients who received iKM, including acupotomy, it was observed that neck pain as determined by the NRS score decreased by 2.31±1.52 from pre-admission to discharge [12]. A prospective observational study conducted at our hospital on hospitalized CDH patients showed that neck pain NRS scores decreased by 2.71 (95% CI, 2.33 to 3.09) from admission to discharge [15]. Furthermore, a retrospective observational study on patients who received steroid injections for cervical radiculopathy showed that neck pain NRS scores following treatment were sustained with a reduction of 4.2 at 1-year post-treatment compared with baseline scores [22]. While a direct comparison is challenging due to differences in treatment duration and interventions, the change in NRS score at discharge for hospitalized patients was roughly similar to the change observed after 4 weeks of outpatient treatment in this study. In addition, the NRS score reduction baseline to the 1-year mark was approximately equivalent to the value observed after the epidural steroid injections.

Examining another subjective pain assessment outcome using the VAS, the MCID using data from patients who underwent anterior cervical discectomy and fusion for cervical radiculopathy was 2.6 for neck pain and 4.1 for arm pain [23]. In the present study, a reduction of this magnitude was reached at Weeks 4–6 for neck pain and Weeks 8–12 for arm pain. Furthermore, this effect was sustained and even exceeded these MCID values during the long-term follow-up.

A prospective observational study that performed cervical disc arthroplasty for degenerative cervical disc disease reported that the NDI score decreased from a baseline score of 24.1 to 12.3 and was maintained at 1 year [24].

Consistent with a previous study assessing arm and neck pain scales to evaluate effectiveness following spinal surgery, a MCID of 7.5 in the NDI was observed which led to an improvement in quality of life [21], which the current study also observed using the NDI.

Another study that followed up patients for 1 year after decompressive surgery for degenerative cervical myelopathy showed a decrease in NDI pain scores, the primary outcome, by 10.0 (95% CI, 8.4 to 11.5), an increase in EQ-5D-5L scores of 0.16 (95% CI, 0.13 to 0.19), and in EQ-VAS scores of 13.8 (95% CI, 11.7 to 15.9) [25]. This finding showed a numerical change similar to the results of the quality-of-life outcome measures in the current study. Compared with these prior studies using Western conservative methods, the results of the current study demonstrated that iKM was effective.

Meanwhile, the intervention in this study, iKM treatment, was designed to reflect real-world clinical practice, which allowed for the evaluation of its effectiveness and safety, particularly in an outpatient setting. As a result, strict restrictions were not placed on the interventions, leading to heterogeneity in treatment. However, the 4 hospitals that recruited patients were all affiliated branch hospitals, sharing the protocol. Analysis of the electronic medical records revealed no significant deviations from the treatment protocol, indicating that heterogeneity was not as substantial a concern as might be expected.

The therapeutic model within this Korean medicine protocol has proven efficacy in numerous prior studies. The main herbs in the protocol have demonstrated anti-inflammatory, neuroprotective, and chondroprotective effects in both in vivo and in vitro experiments [26–28] and have been clinically determined not to be inferior to Celecoxib for osteoarthritis [29]. The frequently used pharmacopuncture solutions also included Shinbaro 1–2, which is based on the main herbs mentioned previously, and Shinbaro 3, which utilizes Harpagophytum procumbens for its analgesic and anti-inflammatory effects [30]. In addition, bee venom pharmacopuncture is another widely used solution in clinical practice, known for its anti-inflammatory, analgesic, and immune-system-activating properties [31]. Acupuncture and electroacupuncture, as representative treatments in Korean medicine, induce effects such as neurotransmitter secretion, the activation of pain modulation pathways, and muscle relaxation [32,33]. Chuna therapy is also a noninvasive treatment method that is effective for alleviating neck pain and restoring function [34]. This form of Korean medicine treatment in protocols has previously been reported to provide short- and long-term effects in relieving pain and improving the quality of life for patients with cervical and lumbar disc herniation [15,35–39].

During this study, none of the patients underwent surgery, despite 18 patients who had been recommended for surgery at other hospitals. Furthermore, only 1 patient received an injection procedure during the treatment period, and 4 patients received it during the follow-up period. Employing Korean medicine treatment, as a conservative treatment method, could be a primary option, especially when considering the potential disadvantages of procedures and surgery, such as adverse effects.

This study has several limitations. Firstly, as a single-arm observational study without a control group, it is not possible to determine the effectiveness of individual treatment components or to compare the effectiveness of this Korean medicine intervention with standard care. The extent of the effects of previous Western treatments prior to, during, and following the study interventions, together with Korean medicine interventions, could not be characterized in this study. Therefore, the findings of this study can only be used to describe the effects of integrative medicine, Western medicine, and Korean medicine treatment, which can serve as preliminary data for the practical design of randomized controlled trials in the future. Secondly, in a similar vein, as an observational study, not all variables that could influence the treatment outcome were controlled. Therefore, a specific causal relationship cannot be definitively established, and caution should be exercised to avoid over-interpretation of the effects. Finally, although there was minimal dropout for most survey-based follow-ups, including telephone interviews, the response rate for in-person variables such as VAS and ROM gradually decreased over time. This is thought to be a natural result of reduced compliance as time passes, as well as a decreased interest as the level of pain reduces. Nevertheless, these missing values constituted a small portion of the total dataset.

Despite these limitations, this study provides evidence to support limited research and serves as foundational data for future randomized controlled trials. We confirmed that for CDH patients in a clinical setting, the pain reduction and quality of life improvement effects of receiving integrative medicine, Western medicine, and Korean medicine treatment for approximately 8 weeks were sustained up to 1 year. Subsequent research could be directed toward establishing evidence by using a control group to establish the effectiveness of Korean medicine or by standardizing individual treatment methods.

Conclusion

Although this study was limited (as a single-arm observational design, which makes it difficult to draw definitive conclusions), the results suggested that integrative medicine treatment may be associated with favorable results including pain relief, functional recovery, and quality of life improvement for CDH patients, with these improvements observed to persist for up to 1 year. No cases in this study proceeded to additional surgery, which may suggest that Korean medicine is an effective conservative treatment method for CDH. Future research could consider a longer follow-up period or an RCT on a specific treatment modality.

Supplementary Materials

Article information

Author Contributions

Conceptualization: YJL and IHH. Investigation: YJA, SK, YL, and HWC. Writing – review & editing: YJL, IHH.

Conflicts of Interest

The authors have no conflicts of interest to declare.

Author Use of AI Tools Statement

The authors declare that Generative AI was not used in the preparation of this manuscript.

Funding

This research was supported by the Korean Health Industry Development Institute (grant no.: RS-2023-KH139336).

Ethical Statement

This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Jaseng Hospital of Korean Medicine (approval no.: JASENG 2019-04-009, JASENG 2019-04-010, JASENG 2019-04-011, and JASENG 2019-04-013). Informed consent was obtained from all participants prior to their participation in the study.

Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Figure 1

Flow chart of study.

Figure 2

Linear mixed model graph of NRS change for study.

Treatment-period: baseline-Week 8, Follow-up period: Week 8–1 year.

NRS = numeric rating scale.

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