1. Introduction
Vertebral compression fractures (VCFs) occur when the anterior column of the vertebral body decreases owing to axial compression. [ 1 ] VCFs may lead to physical limitations, including back pain, functional disability, and progressive kyphosis of the thoracic spine. In severe cases, VCFs may result in decreased appetite, poor nutrition, and impaired respiratory function. Furthermore, associated morbidities may lead to a permanent loss of mobility, causing debilitating disability and a reduced quality of life. [ 2 ]
The primary etiology of VCFs is osteoporosis, [ 3 ] and in younger populations, VCFs may occur secondary to traumatic events, such as falls, sports injuries, and road traffic accidents. In middle-aged and older populations, the incidence of VCFs increases with progressively decreasing bone density and physical function associated with aging. [ 4 ] A study reported that VCFs were confirmed in 25% to 50% of radiographic findings of individuals aged ≥ 50 years. [ 3 ] According to statistics on “frequent surgical disease (2019–2021)” published by the Health Insurance Review & Assessment Service and Korean Statistical Information Service, fracture of the lumbar spine and pelvis (S32) ranked 12th. The number of patients hospitalized under diagnosis codes for fracture of the ribs, sternum, and thoracic spine (S22) and for fracture of the lumbar spine and pelvis (S32) was ≥ 70,000 for the period 2017 to 2021. [ 5 ]
The treatment for VCF can generally be classified into surgical and conservative modalities. Percutaneous vertebroplasty and percutaneous kyphoplasty are surgical treatments used in clinical practice to restore the vertebral body by injecting acrylic cement. Conservative treatment includes bed rest, analgesics, spinal orthoses, and exercise programs. [ 1 , 6 ] Conservative management is typically recommended as the first-line treatment for VCF, [ 7 ] and surgical treatment may be considered if neurological symptoms are present or if compression of the vertebral body is severe. [ 1 ] However, surgical treatment is associated with risks, such as paravertebral soft tissue injury and nerve root compression related to cement leakage, [ 8 , 9 ] and incurs a higher cost of care. Therefore, the surgical approach for VCF should be cautiously considered. [ 1 ]
In traditional Korean medicine (KM) hospitals and clinics, several methods, including acupuncture, moxibustion, herbal medicine, pharmacopuncture, and cupping, are used to treat VCFs, in addition to conventional conservative treatment such as absolute bed rest and use of spinal orthoses. [ 10 ] The number of patients visiting KM hospitals and clinics for thoracic/lumbar spine fractures increased 3-fold in 2016 compared to that in 2011. [ 4 ] Individual case reports on treating compression fractures with acupuncture and pharmacopuncture, [ 11 ] Doinseunggi-tang, [ 12 ] acupuncture with band training, [ 13 ] and burning acupuncture [ 14 ] have been published. Several randomized controlled trials conducted in China and Germany have shown low levels of evidence. [ 1 , 15 ] Specifically, no studies have reported the long-term outcomes of KM treatment for VCFs. Hence, high-level evidence demonstrating the effectiveness of KM treatment for VCFs is lacking.
Consequently, this study aimed to investigate the effectiveness of integrative KM (IKM) treatment and evaluate long-term outcomes in patients with thoracolumbar VCFs who received IKM treatment.
2. Materials and methods
2.1. Study design
Patients with VCFs who underwent IKM treatment at 1 of the 4 KM hospitals in Korea from April 1, 2016, to June 30, 2022, were included. KM treatment was provided after diagnosis, which was confirmed using radiography, magnetic resonance imaging, and computed tomography by radiologists.
The study protocol was approved by the relevant Institutional Review Board (approval no, JASENG 2023-03-012) and registered at ClinicalTrials.gov ( NCT05912504 ). Owing to the nature of the study design, this study was exempt from the mandatory process of obtaining written informed consent. All participants verbally consented to participate in the study after receiving a thorough explanation.
2.2. Participants
2.2.1. Inclusion criteria
Patients who underwent inpatient treatment at the study institution for a compression fracture of the thoracic or lumbar vertebrae as their chief complaint.
Patients diagnosed with “compression fracture” of the thoracic or lumbar vertebrae based on radiography, magnetic resonance imaging, or computed tomography results.
Patients aged ≥ 19 years and ≤ 80 years.
Patients who provided voluntary verbal consent to participate in the study.
2.2.2. Exclusion criteria
Patients whose length of hospital stay was <7 days.
The location of the vertebral fracture was not the vertebral body but the transverse or spinous process.
Other chronic conditions that may interfere with the interpretation of treatment effects or outcomes, including cardiovascular disease, kidney disease, diabetic neuropathy, dementia, and epilepsy.
Pain caused by soft tissue diseases, such as tumors, fibromyalgia, rheumatoid arthritis, and gout, and not spinal diseases.
Patients with congenital spinal disorders.
Patients within 3 months from their spinal surgery.
Patients incapable of normal communication due to dementia or mild cognitive impairment.
Patients that the researcher deemed unsuitable for study participation.
Individuals who refused to provide consent for study participation.
2.3. Analysis of electronic medical records (EMRs)
Patient data, including age, sex, date of onset, trigger, length of hospital stay, diagnosis, smoking status, alcohol consumption, and details of treatments received, were collected from EMRs. In addition, the acute/non-acute status of each patient was classified using the EMR data, with the criterion for determining this e acute/non-acute condition being whether the time elapsed from onset was 3 months. [ 16 ] Information on comorbidities at the time of admission and the patients’ current medications was collected, and numeric rating scale (NRS) scores for low back pain (LBP), Oswestry Disability Index (ODI) scores, and EuroQol 5-dimension 5-level (EQ-5D-5L) scores at admission and discharge were recorded. Radiographic images were used to determine the location and type of VCF. The acute/non-acute status of the compression fracture was analyzed based on radiologists’ reading and interpretation of the results.
2.4. Follow-up survey
A follow-up survey was conducted via telephone between April and July 2023. During the survey, information on NRS, ODI, EQ-5D-5L, and Patient Global Impression of Change scores was collected. Additional information collected included whether the patient underwent a VCF surgery before or after hospitalization, any postoperative complications, whether the patient received any treatment after discharge, presence of a new compression fracture, whether the patient received any treatment in the last month and their types (if any), level of satisfaction with the inpatient treatment provided by the study institution, the reason for satisfaction, and preference between KM/Western medicine (WM, indicating conventional medicine) treatment. The satisfaction survey on the inpatient treatment provided by the study institution was conducted using a 5-point Likert scale: “very satisfied,” “satisfied,” “neutral,” “not satisfied,” and “very dissatisfied.” For KM/WM preference, the subjective preference of the patient was indicated by scores ranging from 1 (minimum) to 10 (maximum).
2.5. Treatment
Inpatients received IKM treatment based on the clinical judgment of the KM doctors (KMDs). The IKM treatment regimen consisted of herbal medicine, acupuncture, pharmacopuncture, Chuna manual therapy (CMT), moxibustion, cupping, herbal medicine hot packs, traction, and manual therapy. The EMRs of inpatients were reviewed, and information on treatments and frequency of each treatment administered during hospitalization was collected.
2.5.1. Herbal medicine
Chungpa-Juhn primarily consists of Acanthopanax sessiliflorus , Eucommiae Cortex , Saposhnikoviae Radix , Achyranthes bidentata Blume, and Cibotii Rhizoma , which have been reported for their anti-inflammatory and analgesic effects. This herbal medicine was included in the basic prescription, as well as Cheongsinbaro-hwan and Ungeoonbi-hwan. [ 17 , 18 ] Based on the symptoms of individual patients and clinical judgment of the KMDs, Jeopgol (capsule), Bogolyanggeun-tang, or Eohyeoljitong-hwan were also included in the prescription. Patients were instructed to take the herbal medicine 30 minutes after meals, 2 to 3 times daily, according to their conditions and symptoms.
2.5.2. Acupuncture and electroacupuncture
Disposable stainless-steel filiform needles (0.25 × 30 mm; Dongbang Medical, Seongnam, Korea) were used for acupuncture. The selection of acupoints around the thoracic/lumbar spinal region was based on the clinical judgment of the KMDs performing the procedure. Needles were inserted at depths of 0.5 to 1.0 cm and retained for 15 minutes. Acupuncture and electroacupuncture were administered twice daily, with both procedures following the same protocol.
2.5.3. Pharmacopuncture
Pharmacopuncture is a KM treatment that combines the physical stimulation of acupuncture with the chemical effects of herbal medicine by injecting a prescribed amount of purified extracts using a disposable syringe (29G × 13 mm, 1 mL; Sungshim Medical, Bucheon, Korea). [ 19 ] Pharmacopuncture was administered by injecting the solution into acupoints around the thoracic/lumbar spinal region. Pharmacopuncture solutions, such as Shinbaro pharmacopuncture (Jaseng Spine and Joint Research Institute, Namyangju, Korea) and Jaseng Bee Venom Pharmacopuncture 5% or 10% (Jaseng Spine and Joint Research Institute, Namyangju, Korea), were administered at the discretion of the KMDs. Pharmacopuncture was administered once or twice per day.
2.5.4. Chuna manual therapy
CMT is a manipulation-based KM therapy used to treat structural or functional issues in the musculoskeletal system. It is performed by a KMD using the hands or other parts of the body and an assistive tool, such as the Chuna table, to correct displacement or alignment through passive movements, thereby restoring normal functions and structure. [ 20 ] CMT was performed once daily for approximately 10 to 15 minutes, based on the symptoms and progress of individual patients as determined by the KMDs. In cases of acute VCF, CMT was either not administered or was adjusted according to the patient’s symptoms and range of motion at the discretion of the KMDs.
2.5.5. Other treatments
For KM physical therapy, herbal medicine hot packs were used. The hot packs are steamed herbal medicine sachets containing 23 ingredients ( A bidentata Blume, Saposhnikoviae Radix , Angelicae dahuricae Radix, etc) with anti-inflammatory and analgesic effects. Hot pack therapy was applied to the lumbar region for 15 to 20 minutes once daily. Cupping therapy was performed for 15 minutes twice daily on the painful areas of the thoracolumbar region, concurrently with acupuncture therapy. Disposable sterile cups (Dongbang Medical, Seongnam, Korea) were used for cupping. However, if required, WM treatments, such as manual therapy or physiotherapy, were administered through collaborative consultation/referral with WM doctors.
2.6. Outcomes
2.6.1. Primary outcome
2.6.1.1. Thoracolumbar vertebral pain intensity scale: NRS
The NRS is a pain rating scale used to objectively assess the subjective pain experienced by patients. [ 21 ] The NRS is an 11-point scale where the patient selects “0” for no pain and “10” for the worst pain imaginable. The severity of LBP was assessed using the NRS.
2.6.2. Secondary outcomes
2.6.2.1. Functional scale: ODI
The ODI is a commonly used questionnaire that assesses the functional disability status of patients with LBP and their daily activities. The questionnaire consists of 10 questions, covering activities such as lifting, walking, sitting, standing, sleeping, sexual life, social life, traveling, and other items. Each question has 6 levels of assessment (scored from 0 to 5 points). Higher scores indicate more severe disability. A validated Korean version of the ODI was used in this study. [ 22 ]
2.6.2.2. Quality of life: EQ-5D-5L
The EQ-5D-5L questionnaire was developed to assess health-related quality of life and is widely used in healthcare settings. The EQ-5D-5L consists of 5 dimensions: mobility, self-care, usual activities, pain, and anxiety/depression. A 5-point Likert scale was used for each question (level 1: no problems; level 2: slight problems; level 3: moderate problems; level 4: severe problems; and level 5: extreme problems). The total score ranges 0 to 1, with higher scores indicating a higher health-related quality of life. [ 23 ] A validated Korean version of the EQ-5D-5L [ 23 ] was used.
2.6.2.3. Patient Global Impression of Change
The Patient Global Impression of Change is a self-reported measure that allows patients to assess their improvement subjectively using 7 levels: very much improved; much improved; minimally improved; no change; minimally worse; much worse; and very much worse. This measure was originally developed for psychological assessment but is now applied in a wide range of medical fields to assess pain improvement. [ 24 ]
2.7. Statistical analysis
In this study, a retrospective review of the EMRs and an analysis of the survey results were conducted. All statistical analyses were conducted using two-sided tests, with statistical significance set at 5%. Descriptive statistics were used to analyze the general demographic data of the participants, including sex, age, and medical history.
Outcomes (NRS, ODI, and EQ-5D-5L scores) at admission, discharge, and long-term follow-up via phone are presented as means and standard deviations (SDs). Continuous variables are presented as means with SDs, and categorical variables are expressed as frequencies (%).
The study endpoints were the changes in continuous outcomes (NRS, Visual Analog Scale, and EQ-5D-5L scores) at each time point (admission, discharge, and follow-up) from baseline. The outcomes at each time point are presented as least square means and 95% confidence intervals (CIs), estimated using the linear mixed model (LMM). Changes in the outcomes from the baseline are also presented using the LMM, along with 95% CI and P -values. Time was included as a categorical variable, and baseline outcome, age, and sex were used as covariates.
To evaluate differences in improvement over time based on patients’ previous VCF treatment experience, we used the number of fracture levels (1 level, ≥2 levels), acute/non-acute status, and trigger for the onset of current pain (traumatic, others). LMM was used to analyze each factor/predictor at baseline, discharge, and long-term follow-up. The mean baseline values were calculated by pooling data from all participants, and outcome values at discharge and follow-up are represented as least squares means with 95% CIs. Differences in the outcome changes between the 2 groups and corresponding P -values were calculated using LMM. Results were adjusted for baseline characteristics, age, and sex. Time was included as a categorical variable, and cross-terms between each factor/predictor and time were also included. All changes are expressed as 95% CIs with P -values.
For all items included in the long-term follow-up survey, categorical values are expressed as frequencies and percentages (%), and continuous variables are presented as means and SDs.
Logistic regression analysis was performed to identify factors affecting treatment satisfaction. Responses indicating “1: much better” or “2: better” were classified as satisfaction responses. The variables included in the model were sex, age, length of hospital stay, trigger for the onset of current pain, previous VCF operation status, number of fracture levels, and acute/non-acute status. Univariate analysis was conducted to evaluate the association between each variable and the level of satisfaction. Multivariate analysis was subsequently conducted. Each estimate is expressed as an odds ratio (OR) with 95% CI, and the area under the curve values are presented for the multivariate model. All analyses were conducted using R 4.2.1 for Windows (R Foundation for Statistical Computing, Vienna, Austria).
3. Results
3.1. Participants
From April 1, 2016, to June 30, 2022, a total of 994 patients underwent inpatient treatment for fractures at 4 KM hospitals. Among them, 711 patients were diagnosed with a “compression fracture.” Patients with radiographic findings of vertebral transformation due to burst fractures (n = 8) or degenerative changes (n = 1) were excluded from the analysis. In addition, 332 patients who refused to receive text messages or participate in the study were excluded. Therefore, long-term follow-up was conducted for 370 patients. The data collected from 166 patients who responded to the survey were analyzed (Fig. 1 ).
3.2. Participant characteristics
The basic characteristics and clinical features of the study participants are presented in Table 1 . The mean age of the participants was 63.28 ± 12.64 years, with more female patients (n = 124 [74.7%]) included. More than half of the patients had a hospitalization period of <4 weeks, with 54 patients (32.5%) staying for 2 to 4 weeks and 53 patients (31.9%) for 1 to 2 weeks. Trauma was the major cause of pain in 104 patients (62.7%). A total of 22 patients (13.3%) reported having a history of VCF surgery. Lumbar spine fractures were more dominant (123 patients; 74.1%) than thoracic spine fractures, and most participants (115 patients; 69.3%) experienced compression fractures at 1 site. More participants (105 patients, 63.3%) reported non-acute fractures.
Table 1
Basic characteristics of participants at admission (N = 166).
Values are presented as frequencies and percentages or means and standard deviations. EQ-5D-5L = EuroQol 5-Dimension 5-Level, LBP = lower back pain, NRS = numeric rating scale, ODI = Oswestry Disability Index, RP = radiating pain, SD = standard deviation, VCF = vertebral compression fracture.
| Variable | N = 166 |
| Sex | |
| Male | 42 (25.3) |
| Female | 124 (74.7) |
| Age, yr | |
| (Mean ± SD) | 63.28 ± 12.64 |
| <50 | 23 (13.9) |
| 50–59 | 20 (12.0) |
| 60–69 | 65 (39.2) |
| ≥70 | 58 (34.9) |
| Total admission period | |
| 1–2 wk | 53 (31.9) |
| >2 and < 4 wk | 54 (32.5) |
| >4 and < 6 wk | 31 (18.6) |
| Over 6 wk | 28 (16.9) |
| Smoking (N = 165) | |
| Past smoking | 1 (0.6) |
| Current smoking | 17 (10.3) |
| Nonsmoking | 147 (89.1) |
| Drinking | 30 (18.1) |
| Employment | |
| No occupation (including housewives and students) | 116 (69.9) |
| Managers | 5 (3.0) |
| Professionals and related occupations | 5 (3.0) |
| Office workers (clerical) | 13 (7.8) |
| Service and sales workers | 12 (7.2) |
| Skilled agricultural, forestry, and fishery workers | 4 (2.4) |
| Craft and related trades | 2 (1.2) |
| Plant and machine operators and assemblers | 5 (3.0) |
| Elementary occupations | 4 (2.4) |
| Time from fracture to admission (days, n = 59) | |
| Mean (SD) | 115.80 (429.31) |
| Median (Q1, Q3) | 8.5 (2, 62.5) |
| Present pain onset | |
| Trauma | 104 (62.7) |
| Osteoporosis | 11 (6.6) |
| Others | 24 (14.5) |
| Unknown | 27 (16.3) |
| Number of times analgesics were taken during the last week (Mean ± SD) | 1.98 ± 4.78 |
| Number of steroid injections related to LBP (Mean ± SD) | 0.40 ± 1.84 |
| Number of operations/procedures received due to low back problems (Mean ± SD) | 0.17 ± 0.61 |
| VCF operation | 22 (13.3) |
| History of illness (N = 96) | |
| Diabetes mellitus | 15 (15.6) |
| Osteoporosis | 15 (15.6) |
| Cerebrovascular disease | 52 (54.2) |
| Thyroid disease | 8 (8.3) |
| Others | 28 (29.2) |
| Analgesic dose associated with VCF (N = 165) | 37 (22.4) |
| Compression fracture vertebral body | |
| Thoracic | 66 (39.8) |
| Lumbar | 123 (74.1) |
| Compression fracture vertebral level | |
| 1 level | 115 (69.3) |
| 2 level | 37 (22.3) |
| >3 level | 14 (8.4) |
| Compression fracture type | |
| Acute | 61 (36.7) |
| Chronic | 105 (63.3) |
| NRS score at admission for LBP (Mean ± SD) | 5.75 ± 1.40 |
| NRS score at admission for RP (N = 75; Mean ± SD) | 5.43 ± 1.90 |
| EQ-5D-5L score at admission (Mean ± SD) | 0.59 ± 0.20 |
| ODI score at admission (Mean ± SD) | 48.92 ± 19.08 |
3.3. Inpatient treatment
Details of the treatment received by the inpatients are summarized in Table S1, Supplemental Digital Content, https://links.lww.com/MD/R98 . The inpatient IKM treatment regimen included herbal medicine, acupuncture, electroacupuncture, pharmacopuncture, and CMT. Herbal medicines such as Chungpa-Juhn, Cheongsinbaro-hwan, and Ungeoonbi-hwan were prescribed to 98 patients (59%). Pharmacopuncture was administered to 164 patients (98.8%), whereas bee venom pharmacopuncture was administered to 30 patients (18.1%).
3.4. Outcome changes
Following the completion of IKM treatment, all outcomes, including the NRS for LBP, ODI, and EQ-5D-5L scores, demonstrated statistically significant improvement, which was maintained up to the time of long-term follow-up (Table 2 and Fig. 2 ). At admission, the mean NRS score for LBP was 5.75 (95% CI 5.53–5.96), which decreased to 3.36 (95% CI 3.08–3.64) and 3.90 (95% CI 3.62–4.18) at discharge and follow-up survey, respectively. The ODI score decreased from 48.92 (95% CI 46.02–51.82) at admission to 35.95 (95% CI 33.04–38.86) at discharge and to 27.67 (95% CI 24.86–30.47) at the long-term follow-up survey (Table 2 and Fig. 2 ).
Table 2
Changes in outcomes after treatment.
EQ-5D-5L = EuroQol 5-Dimension 5-Level, LBP = lower back pain, NRS = numeric rating scale, ODI = Oswestry Disability Index. *** P < .001.
| Admission (baseline) | Week 2 | Discharge | Follow-up | |
| NRS for LBP | ||||
| Value | 5.75 (5.53 to 5.96) | 4.07 (3.71 to, 4.43) | 3.36 (3.08 to 3.64) | 3.90 (3.62 to 4.18) |
| Difference | – | 1.68 (1.32, 2.04) | 2.38 (2.11, 2.66) | 1.85 (1.57 to 2.13) |
| P -value | – | <.001 *** | <.001 *** | <.001 *** |
| ODI | ||||
| Value | 48.92 (46.02 to 51.82) | 42.14 (38.41 to 45.88) | 35.95 (33.04 to 38.86) | 27.67 (24.86 to 30.47) |
| Difference | – | 6.78 (3.04 to 10.51) | 12.97 (10.06 to 15.88) | 21.25 (18.45 to 24.06) |
| P -value | – | <.001 *** | <.001 *** | <.001 *** |
| EQ-5D-5L | ||||
| Value | 0.59 (0.56, 0.62) | 0.67 (0.64 to 0.70) | 0.72 (0.70 to 0.75) | 0.75 (0.73 to 0.78) |
| Difference | – | −0.08 (−0.11 to −0.04) | −0.13 (−0.15 to −0.10) | −0.16 (−0.18 to −0.13) |
| P -value | – | <.001 *** | <.001 *** | <.001 *** |
3.5. Analysis of outcome changes by disease characteristics
Outcomes according to the number of compression fractures are shown in Figure 3 and Table S2, Supplemental Digital Content, https://links.lww.com/MD/R98 . The NRS scores for LBP were lowest at discharge immediately following the completion of IKM treatment, regardless of the number of compression fractures. At long-term follow-up, patients with 1 compression fracture (fracture at a single site) maintained the improvement achieved by IKM treatment, whereas those with 2 or more compression fractures (fractures at 2 or more levels) displayed a slight worsening in their outcomes (difference: −0.83, 95% CI −1.38 to −0.29, P < .05). The EQ-5D-5L score was significantly higher in patients with 1 compression fracture than in those with 2 or more compression fractures (difference: 0.05, 95% CI 0.01–0.10, P < .05).
Outcome changes according to the acute/non-acute status of the patients are presented in Figure 4 and Table S3, Supplemental Digital Content, https://links.lww.com/MD/R98 . The NRS scores for LBP indicated continuous improvement at week 2 and discharge, but the score increased slightly at follow-up. The ODI and EQ-5D-5L scores showed similar trends, where the non-acute group exhibited faster improvement up to week 2, followed by a decline in the improvement rate, resulting in greater improvement in the acute group at follow-up.
The effects of VCF surgery before IKM treatment are shown in Figure 5 and Table S4, Supplemental Digital Content, https://links.lww.com/MD/R98 . The NRS scores for LBP showed a similar trend of improvement in both the surgery and non-surgery groups at week 2 and discharge. However, at long-term follow-up, the surgery group exhibited a greater increase in the NRS score than the non-surgery group. The ODI and EQ-5D-5L scores showed similar trends, with the surgery group exhibiting rapid improvement at week 2, followed by aggravation thereafter. However, in the non-surgery group, both ODI and EQ-5D-5L scores showed gradual improvement up to the time of long-term follow-up. The non-surgery group exhibited a greater level of improvement than the surgery group, particularly in EQ-5D-5L scores. The difference between the 2 groups was statistically significant (difference: −0.10, 95% CI −0.18 to 0.01; P < .05).
3.6. Survey outcomes at long-term follow-up
Among the 166 participants who responded to the long-term follow-up survey, 10 patients (6%) reported that they underwent surgery after discharge, and 60 patients (36.1%) received additional treatment after discharge. Acupuncture was the most frequently received treatment (25 patients; 41.7%). The mean frequency of treatment during the previous month was 2.33 ± 4.94, whereas two-thirds of the participants (107 patients; 64.8%) received no additional treatment during that period. The level of satisfaction for KM treatment was 1.76 ± 0.8, with “very satisfied” accounting for the highest proportion of responses (79 patients; 47.6%). Acupuncture was selected as the most satisfactory treatment among the KM treatments (110 patients; 73.3%), followed by pharmacopuncture (64 patients; 42.7%). The primary reasons for KM treatment satisfaction were its high effectiveness (100 patients [62.5%]) and achieving treatment effects without the use of analgesics (34 patients [21.2%]). In terms of treatment preference, the scores for KM and WM treatments were 7.32 ± 2.03 and 5.99 ± 2.19, respectively, indicating a higher preference for KM treatment (Table 3 ).
Table 3
Long-term follow-up survey results.
CMT = Chuna manual therapy, KM = Korean medicine, LBP = lower back pain, PGIC = Patients’ Global Impression of Change, VCF = vertebral compression fracture, WM = Western medicine.
| Survey item | Value |
| N = 166 | |
| Surgery after discharge | 10 (6.0) |
| Additional treatment for LBP after discharge | 60 (36.1) |
| Herbal medicine | 8 (13.3) |
| Acupuncture | 25 (41.7) |
| Cupping | 10 (16.7) |
| CMT | 5 (8.3) |
| Pharmacopuncture | 19 (31.7) |
| Moxibustion | 8 (13.3) |
| Physiotherapy | 22 (36.7) |
| Manual therapy | 3 (5.0) |
| Decompression/traction | – |
| Rehabilitation | 3 (5.0) |
| Injections | 21 (35.0) |
| Medications (analgesics) | 20 (33.3) |
| Others | 2 (3.3) |
| Number of treatments received during the previous month (N = 173) | |
| (Mean ± SD) | 2.33 ± 4.94 |
| 0 | 107 (64.8) |
| 1–3 | 20 (12.2) |
| <10 | 23 (13.9) |
| ≥10 | 15 (9.0) |
| Onset of new VCF after discharge (N = 165) | 17 (10.3) |
| Satisfaction: KM treatment | |
| (Mean ± SD) | 1.76 ± 0.86 |
| 1, Very satisfied | 79 (47.6) |
| 2, Satisfied | 55 (33.1) |
| 3, Neutral | 25 (15.1) |
| 4, Not satisfied | 7 (4.2) |
| 5, Very dissatisfied | – |
| KM treatments with the highest level of satisfaction | |
| Herbal medicine | 50 (33.3) |
| Acupuncture | 110 (73.3) |
| Cupping | 20 (13.3) |
| CMT | 35 (23.3) |
| Pharmacopuncture | 64 (42.7) |
| Moxibustion | 12 (8.0) |
| KM physical therapy | 31 (20.7) |
| Others | – |
| Reasons for satisfaction with KM treatment | |
| Satisfactory effects of treatment | 100 (62.5) |
| Availability of various modes of treatment | 31 (19.4) |
| Treatment effects were achieved without analgesics | 34 (21.2) |
| Availability of both pain management and fundamental curative treatment | 18 (11.2) |
| Few side effects after treatment | 16 (10.0) |
| Well-established KM–WM collaborative referral system | 8 (5.0) |
| Unsatisfactory | 13 (8.1) |
| Others | 5 (3.1) |
| Treatment preference (Mean ± SD) | |
| KM | 7.32 ± 2.03 |
| WM | 5.99 ± 2.19 |
| PGIC at long-term follow-up | |
| Much better | 28 (16.9) |
| Better | 72 (43.4) |
| A little better | 46 (27.7) |
| No change | 13 (7.8) |
| A little worse | 2 (1.2) |
| Worse | 5 (3.0) |
| Much worse | – |
3.7. Factors affecting treatment satisfaction
A multivariate logistic regression model was used to analyze the factors affecting treatment satisfaction at the long-term follow-up (Table 4 ). The odds for treatment satisfaction were lower for female patients than for male patients (OR 0.46, 95% CI 0.18–1.17), but the difference was not statistically significant. Patients aged ≥ 60 years reported higher levels of satisfaction than those aged ≤ 50 years (OR 5.88, 95% CI 1.29–26.92, P = .022). In addition, the odds of treatment satisfaction were lower for patients with VCFs caused by trauma than for those with VCFs caused by other reasons (OR 0.37, 95% CI 0.15–0.89, P = .027). The results of the univariate logistic regression analysis for each factor are presented in Table S5, Supplemental Digital Content, https://links.lww.com/MD/R98 .
Table 4
Factors affecting treatment satisfaction.
AUC = area under the curve, CI = confidence interval, OR = odds ratio, PGIC = Patients’ Global Impression of Change, ref = references, VCF = vertebral compression fracture, etc: includes osteoporosis, degenerative, unknown. * P < .05.
| Multivariate logistic regression | Follow-up PGIC (1, 2/3, 4, 5, 6, 7) | |
| OR (95% CI) | P -value | |
| Sex (ref. Male) | ||
| Female | 0.46 (0.18–1.17) | .102 |
| Age (ref. <50 yr) | ||
| 50–59 yr | 3.73 (0.71–19.70) | .120 |
| 60–69 yr | 5.88 (1.29–26.92) | .022 * |
| ≥70 yr | 3.00 (0.64–14.13) | .165 |
| Length of hospital stay (ref. <3 wk) | ||
| ≥3 wk | 0.48 (0.21–1.10) | .084 |
| Trigger for the onset of current pain (ref. etc [ 1 ] ) | ||
| Traumatic | 0.37 (0.15–0.89) | .027 * |
| Previous VCF surgery (ref. No) | ||
| Yes | 2.38 (0.61–9.24) | .211 |
| Vertebral level of compression fractures (ref. 1) | ||
| ≥2 | 1.14 (0.50–2.63) | .751 |
| Acute/non-acute status (ref. Non-acute) | ||
| Acute | 0.96 (0.42–2.21) | .930 |
| AUC (95% CI) | 0.70 (0.62–0.79) | – |
4. Discussion
In this study, the outcomes of treatment and satisfaction were surveyed and analyzed in patients with thoracolumbar VCFs who underwent inpatient IKM treatment. As a result, the NRS and ODI scores decreased while the EQ-5D-5L scores increased.
The study included more female patients, with participants aged ≥ 60 years accounting for the majority. This trend in the demographic characteristics of the patients can be explained by a previous study, [ 6 ] which reported that the major risk factors for VCFs are increasing age and a decrease in bone density.
Patients with multi-level VCFs achieved a lower level of improvement than those with single-level fractures. In cases of multiple-level VCFs, patients are more likely to be affected by various risk factors, such as severe osteoporosis and underlying spinal fractures, [ 25 ] which are caused by greater impact, multiple myeloma, or metastatic tumors. [ 26 ] Moreover, previous studies have reported that the risk of subsequent fractures increases with the number of vertebral fractures. [ 27 , 28 ]
Furthermore, 34.5% and 60.3% of patients had acute and non-acute VCFs, respectively. In both groups, pain improved until discharge; however, pain aggravation was confirmed during the long-term follow-up survey. Regarding the ODI and EQ-5D-5L scores, the improvement was greater in the non-acute VCF group until week 2; however, subsequently, the acute VCF group reported superior treatment effects. Many patients with acute VCFs who were highly affected by pain were prescribed analgesics at other hospitals before admission. Therefore, compared with the relatively rapid improvement in pain, the outcomes of functional disability and quality of life did not show substantial improvement among these patients. Patients with non-acute VCFs showed little improvement in their symptoms after discharge, which may be explained by the fact that, over time, compression fractures undergo union and may progress to a spinal deformity that causes kyphosis or scoliosis. [ 29 ]
The VCF surgery and non-surgery groups comprised 13.3% and 86.7% of patients, respectively. In both groups, pain improved up to the time of discharge, but increased slightly thereafter. In terms of functional disability and quality of life, the VCF surgery group exhibited faster improvement, whereas the non-surgery group (conservative treatment group) showed continuous improvement over time, resulting in greater overall improvement in these outcomes. Further research is required to explore the mechanism underlying the faster initial improvement observed in the VCF surgery group when patients received KM treatment. Furthermore, in the non-surgery group, the improvement in outcomes was maintained up to the time of long-term follow-up. This indicates that, in the absence of risk factors such as acute pain or a high initial collapse rate of the vertebral body, [ 30 ] the findings of this study may serve as evidence that KM treatment is effective for patients with VCFs in the long term.
At the long-term follow-up, the VCF operation rate was low at 6%, and the incidence of additional compression fractures was 10% after completion of the inpatient KM treatment regimen. In addition, two-thirds of the total respondents had not received treatment for LBP in the previous month, suggesting that symptoms were well controlled even without additional treatment after discharge. The most cited reason for the high level of satisfaction with KM treatment was its effectiveness, which is consistent with the improvement achieved through this treatment.
IKM treatment administered during the period of hospitalization consisted of acupuncture, including electroacupuncture and pharmacopuncture, herbal medicine, cupping therapy, and physical therapy. Some patients underwent CMT, but it was not directly administered to the thoracolumbar region, which is the area affected in VCFs; instead, it was applied to the neck, shoulders, and legs. The herbal medicine prescription included the formulation of GCSB-5 (traditional name: Chungpa-Juhn) for 60% of the patients. GCSB-5 has been shown to provide pain relief, anti-inflammatory effects, and neuroprotective effects in both in vitro [ 17 , 31 ] and in vivo [ 32 , 33 ] studies. However, no studies have reported the effectiveness of GCSB-5 in VCFs. In addition, acupuncture is effective in pain management because it activates various neural and neuroactive components via mechanical or electrical stimulation. [ 34 , 35 ] The pain associated with VCFs reportedly results from direct stimulation of nociceptors on spinal bones caused by structural damage. [ 36 ] Studies have also reported that pain-related receptors, called polymodal receptors, play an important role in acupuncture treatment for chronic pain. [ 37 ]
This study had some limitations. First, subjective assessment scales were used as outcome measures. During pain assessment using the NRS, the patients selected a score between 0 and 10. However, at long-term follow-up, patients tend to forget the pain score they had previously selected. Therefore, it is possible that the patients selected similar or higher NRS scores even if their symptoms had actually improved. Therefore, outcome measures such as the ODI or EQ-5D-5L, which calculate scores through specific questions on lower back functions during walking or other activities of daily living or on the quality of life, serve as more objective assessment scales that can better reflect the true extent of improvement achieved through IKM treatment. Second, this study is the absence of a control group and the nonuniform observation time for the long-term follow-up survey among all patients. Third, in evaluating the outcomes of patients with VCFs, it is important to identify the exact time of fracture occurrence; however, in this study, there were many missing data, making it difficult to accurately determine the interval from onset. In addition, for patients with chronic fractures, it is crucial to document the treatments they had received prior to admission, but this information was not adequately collected. Lastly, at the time of the long-term follow-up, most patients with VCFs were of advanced age and faced various other challenges, such as difficulty in ambulation due to a recent fall or undergoing surgery for stenosis or degenerative knee cartilage, which impeded the assessment of improvement solely related to the treatment for VCFs.
Despite these limitations, to the best of our knowledge, this study is the first to confirm the long-term effectiveness of IKM treatment for VCFs. The results indicate the potential of KM treatment for compression fractures. On the basis of the findings of this study, IKM treatment can be more widely used to treat VCFs, thereby contributing to improved quality of life for patients.
5. Conclusions
Patients with thoracolumbar VCFs who underwent IKM treatment exhibited improvement in pain and functional disability outcomes, and the improvements were maintained at the long-term follow-up. The findings of this study are expected to provide evidence and supporting data for clinicians to select optimal treatment methods and assess patient prognosis. Further research, including well-designed randomized controlled trials, is required to confirm our findings.
Author contributions
Conceptualization: Yeonsun Lee, Doori Kim.
Data curation: Woojin Jung.
Formal analysis: Soo-Duk Kim, Woo-Chul Shin.
Funding acquisition: In-Hyuk Ha.
Investigation: Hyunsuk Park, Jonghyun Lee, Hyeri Jo.
Methodology: Hyun A. Sim, Woojin Jung, Yeonsun Lee.
Software: Hyun A. Sim.
Supervision: Byung-Kwan Seo, Jae-Heung Cho, Yoon Jae Lee.
Validation: Doori Kim.
Visualization: Hyun A. Sim.
Writing – original draft: Hyun A. Sim, Doori Kim.
Writing – review & editing: In Heo, Yoon Jae Lee, In-Hyuk Ha.
Supplementary Material
Abbreviations: CI confidence interval CMT Chuna manual therapy EMRs electronic medical records EQ-5D-5L EuroQol 5-dimension 5-level IKM integrative Korean medicine KM Korean medicine KMDs Korean medicine doctors LBP low back pain LMM linear mixed model NRS numeric rating scale ODI Oswestry Disability Index OR odds ratio SD standard deviation VCFs vertebral compression fractures WM Western Medicine
HAS and DK contributed to this article equally.
This work was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea [grant number RS-2023-KH139336].
The authors have no conflicts of interest to disclose.
The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.
Supplemental Digital Content is available for this article.
How to cite this article: Sim HA, Jung W, Kim S-D, Park H, Lee J, Jo H, Lee Y, Heo I, Seo B-K, Shin W-C, Cho J-H, Lee YJ, Kim D, Ha I-H. Long-term follow-up of vertebral compression fractures in inpatients treated with integrative Korean medicine: An observational study. Medicine 2026;XX:XX(e46883).
Contributor Information
Hyun A. Sim, Email: sha0404@jaseng.org.
Woojin Jung, Email: wj0119@jaseng.org.
Soo-Duk Kim, Email: doori.k07@gmail.com.
Hyunsuk Park, Email: drpark1253@jaseng.org.
Jonghyun Lee, Email: goodsmile8119@gmail.com.
Hyeri Jo, Email: whgpflgpfl@jaseng.org.
Yeonsun Lee, Email: goodsmile8119@gmail.com.
In Heo, Email: drheoin@pusan.ac.kr.
Byung-Kwan Seo, Email: seohbk@hanmail.net.
Woo-Chul Shin, Email: eddyshin42@naver.com.
Jae-Heung Cho, Email: vetkong95@hanmail.net.
Yoon Jae Lee, Email: goodsmile8119@gmail.com.
Doori Kim, Email: doori.k07@gmail.com.
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