The Effect of Comprehensive and Integrative Medical Services on Patients with Degenerative Lumbar Spinal Stenosis : A Randomized Controlled Study

1. Introduction

Degenerative lumbar spinal stenosis(DLSS) is a prevalent degenerative spinal disorder characterized by narrowing of the spinal canal and subsequent compression of the spinal roots. This compression commonly leads to neurogenic intermittent claudication (NIC), lower leg radiating pain (LLRP), sensory disturbance, motor weakness, and low back pain(LBP) [1]. Both LLRP and referred buttock pain are typically described as stabbing, dull, burning, electric shock-like, numb, or paresthesia-like sensations, and are reported in the majority of patients. Conservative treatment is generally attempted initially; however, when symptoms worsen, functional impairment progresses, or neurological deficits emerge, surgical intervention may be considered due to its substantial impact on quality of life [2].

Conservative treatment options for DLSS include pharmacotherapy, physical therapy, therapeutic exercise, and injection therapies as epidural steroid injections and selective nerve root block (SNRB). In Korea, both western and traditional oriental medical practices coexist. Among oriental modalities, acupuncture has demonstrated significant benefits for LLRP in several studies [3,4,5,6]. Manual therapy—including joint mobilization or correction, soft tissue mobilization, neural mobilization, and stabilization exercises—has also been shown to reduce pain and improve physical function in DLSS [7].

Since 2017, the Ministry of Health and Welfare of Korea has promoted a collaborative care model through the “Western-Oriental Medicine Cooperation Pilot Project”, which evolved into a comprehensive integrative medical service (CIMS) model. CIMS combines mechanism-targeted analgesic interventions (e.g., acupuncture), functional restoration strategies (manual therapy and exercise), and microcirculatory enhancement (cupping) [8]. The multimodal approach aligns with the multifactorial pathophysiology of DLSS, potentially yielding synergistic therapeutic effects.

In a previous pilot randomized controlled study published in 2023, a 6-week, 12-session CIMS program significantly improved pain (VAS) compared with conventional care alone, although improvements in quality of life (SF-36) were not statistically significant [9].

Building upon the methodology and preliminary results of that pilot study, we designed the present assessor-blinded randomized controlled study with a larger sample size and a clinically optimized treatment schedule. This study compared a CIMS-augmented treatment group—receiving acupuncture, cupping therapy, and manual therapy 8 times over 4 weeks—with a control group receiving standard care only (limaprost, pregabalin, and SNRB). This study aimed to evaluate the effects of adjunctive CIMS on pain reduction, functional improvement, overall health status, and safety in patients with DLSS.

2. Materials and Methods

2.1. Study Design and Patient Selection

This study was a single-center, parallel group, randomized, assessor-blinded controlled trial (registered at https://cris.nih.go.kr; KCT 0006036; date of trial registration: March 29, 2021). The study protocol was approved by the Institutional Review Board of Daegu Catholic University Medical Center (approval number: 2022-07-009; date of approval: September 28, 2022). Written informed consent was obtained from all participants prior to enrollment.

Eligible patients were adults diagnosed with degenerative lumbar spinal stenosis and presenting with radiating pain requiring selective nerve root block (SNRB). Neuropathic characteristics of radiating pain were confirmed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), and individuals with a LANSS score > 7 and a visual analog scale (VAS) score > 5 were included. Inclusion and exclusion criteria are detailed in Table 1.

Based on prior results [9], the primary endpoint was VAS. Sample size calculations (α = 0.05, power = 0.80, 10% dropout rate) indicated 40 participants per group (total n = 80). Details are shown in Table 2 and Table 3.

2.2. Treatment Procedures

All participants received SNRB and pharmacotherapy with limaprost and pregabalin. In addition to standard care, the experimental group received CIMS consisting of acupuncture, cupping therapy, and a manual therapy-based massage. CIMS sessions were administered 8 times over a 4-week period.

2.2.1. CIMS Component and Protocol

1. Acupuncture;

Acupuncture treatment followed clinical practice guidelines in oriental medicine for DLSS and prior studies evaluating acupuncture following SNRB [10]. Proximal acupuncture points included Shenshu (BL23), Qihai-shu (BL24), Dachang-shu (BL25), and Huatuo Jiaji (EX-B2). Given the predominance of LLRP in DLSS, distal points included Huantiao (GB30), Weizhong (BL40), and Lunlun (BL60). Disposable sterile filiform needles (0.25 × 40mm and 0.30x60mm) were used, totaling 17 needles per session. Needle insertion was performed with manual stimulation to achieve deqi sensation, needles were retained for 25 ± 5 min. Electroacupuncture was applied at BL23, BL25, and EX-B2 with a frequency of 4 Hz stimulation for 25 ± 5 min, with current intensity adjusted according to patient tolerance.

2. Cupping Therapy;

Cupping therapy was delivered using an electric suction device over areas of maximal tenderness, particularly the back-shu points. Negative pressure was maintained for 5 min. Cupping therapy is intended to promote microcirculation, lymphatic flow, immune activity, and relief of muscle tension-related pain. Previous meta-analyses have demonstrated its clinical benefits, particularly when combined with acupuncture, in conditions such as herpes zoster, facial palsy, and cervical spondylosis [11].

2. Manual therapy-based intervention.

The manual therapy program consisted of 30-min sessions conducted 8 times over 4 weeks. The protocol included palpatory assessment to identify myofascial restrictions, mobilization techniques targeting paraspinal muscles and associated ligaments, myofascial release, therapeutic massage, and stretching exercises, all aimed at alleviating stenosis-related pain and improving functional mobility of the paraspinal muscles and adjacent joints.

3. Point selection summary

• Acupuncture points: BL23, BL24, BL25, EX-B2 (L2-L5), GB30, BL40, BL60.
• Cupping points: Tenderness-related back-shu points (the regions of maximal pain).
• Manual therapy: 30 min per session, 8 sessions total
• Treatment frequency: 8 sessions over 4 weeks

2.3. Randomization and Blinding

Participants were randomized 1:1 ratio to either the experimental or control group. A computer-generated randomization sequence was prepared by an independent statistician, and allocation was concealed until enrollment. Participants were assigned sequential randomization codes (R001, R002, R003, …) upon enrollment. This study employed single blinding, wherein the outcome assessors were blinded to group allocation throughout data collection and evaluation.

2.4. Outcome Measures

At screening visit, demographic data including initials, sex, age, height, weight, comorbidities, and LANSS were recorded. The primary outcome was pain intensity assessed by the VAS at baseline, week 4, week 8, and week 12. Physical function and health status were assessed using the 36-item Short-Form Health Survey (SF-36), and spine-related disability was evaluated using the Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaires (RMDQ) at baseline and at week 4,8, and 12 in both groups. Compliance in the experimental group was evaluated at week 4. For each modality (acupuncture, cupping, and manual therapy-based intervention), adherence(%) was calculated as (number of sessions attended/8)x100. Participants with less than 70% adherence were classified as dropouts.

2.5. Statistical Analysis

All statistical analyses were performed in accordance with national clinical trial statistical guidance by the Korea Food and Drug Administration (KFDA, 2000). Analyses were conducted using IBM SPSS Win. Ver. 19.0 (IBM Corp., Armonk, NY, USA). A two-sided α level of 0.05 was considered statistically significant.

Descriptive statistics were used to summarize baseline demographic and clinical characteristics. Continuous variables were presented as means ± standard deviations and categorical variables as frequencies and percentages. Between-group homogeneity at baseline was assessed using independent two-sample t-tests for normally distributed continuous variables, Mann-Whitney U tests for non-normally distributed variables, and chi-square tests for categorical variables.

For efficacy outcomes (VAS, SF-36, ODI, and RMDQ), repeated-measures two-factor ANOVA was used to analyze changes over time, with factors for time, group, and time x group interactions. When a significant interactions were observed, planned contrasts analyses were performed to identify specific time points showing group differences. Safety analyses included all participants who underwent at least one CIMS session. Adverse events (AEs) were documented and compared between groups using chi-square tests. The proportion of participants experiencing ≥ 1 AE was also evaluated using chi-square tests.

3. Results

3.1. Participant Flow and Baseline Characteristics

A total of 77 participants met inclusion and exclusion criteria and were randomized into either the experimental group (n = 38; 11 men, 27 women) or the control group (n = 39; 14 men, 25 women). Mean age did not differ significantly between groups (experimental 69.74 ± 6.29 years; control 69.28 ± 7.32 years; p = 0.771). All participants exhibited neuropathic radiating pain, with LANSS scores > 7 in both groups. The distribution of comorbid medical conditions differed between groups (experimental n = 4; control n = 0) (Table 4).

3.2. Compliance in the Experimental Group

For the manual therapy-based intervention, 31 of 38 participants achieved 100% adherence; one participant discontinued after 7 sessions due to symptomatic improvement. For acupuncture, 32 of 38 participants achieved 100% adherence. 6 participants discontinued the study in each group.

3.3. Changes in VAS, RMDQ, ODI

Mean VAS scores in the experimental group decreased from 4.73 ± 1.67 at baseline to 3.74 ± 1.68 at week 4, 3.93 ± 2.03 at week 8, 3.98 ± 1.98 at week 12. In the control group, the corresponding scores were 4.70 ± 1.95, 4.66 ± 1.60, 4.79 ± 1.55, and 4.98 ± 1.68, respectively. Repeated-measures two-factor ANOVA revealed a significant time x group interaction for VAS (p = 0.040), indicating greater improvement in the experimental group. For disability outcomes, ODI demonstrated a significant time x group interaction (p = 0.010), consistent with superior functional improvement in the experimental group. However, no significant time x group interaction was observed for RMDQ (p = 0.418) (Table 5).

3.4. Changes in SF-36

No statistically significant time x group interactions were observed across any SF-36 domains (all p > 0.05), indicating that the 12-week intervention period may be have been insufficient to influence multidimensional quality of life measures (Table 6).

4. Discussion

Degenerative lumbar spinal stenosis (DLSS) is a common degenerative spinal disorder that often leads to chronic pain, functional disability, and reduced quality of life. In a previous study, approximately half of patients treated conservatively experienced symptomatic improvement over 4 years, whereas a notable proportion reported persistent or worsening leg or back pain [12]. Consequently, conservative management remains the initial approach when neurological deficits are not severe, with surgical intervention reserved for refractory cases or significant functional impairment.

Conservative treatment encompasses patient education and activity modification, pharmacological therapies (e.g., anti-inflammatory agents, pregabalin, muscle relaxants, limaprost), injection therapies (e.g., epidural corticosteroid injections and selective nerve root blocks), spinal manipulation, bracing, and physical therapy and exercise [13,14]. When conservative management fails, surgical decompression—with or without fusion—may be considered.

Interest in collaborative integrative medical services (CIMS) as an adjunct to standard care has grown in Korea. Since 2017, a national ministry-led pilot program (Phase 3) has supported the implementation of CIMS, integrating acupuncture, cupping, manual therapy, and related modalities with conventional western medical care [9]. Previous real-world evidence have supported the clinical utility of integrative treatment programs [15]. Our previous pilot study also demonstrated that 12 sessions of CIMS improved pain mor effectively than conventional care alone [8].

In the present trial, we expanded the sample size and employed a shorter, clinically practical treatment regimen of 8 sessions over 4 weeks. Despite the reduced treatment intensity, we again observed significantly greater improvement in VAS and ODI in the CIMS group compared with standard care alone. These findings strengthen evidence supporting the role of CIMS as a beneficial adjunctive treatment strategy for DLSS.

It is notable that SF-36 outcomes did not differ significantly between groups, consistent with our prior pilot study. Quality of life domains may require longer treatment duration, more intensive multidisciplinary psychosocial interventions, or follow-up periors beyond 12 weeks to demonstrate measurable change. The persistence of this pattern across studies suggests that pain reduction alone may not suffice to alter complex, multidimensional quality of life indicators.

A multicenter Korean study involving 387 inpatients with lumbar spinal stenosis who received integrative oriental medicine for a mean of 3 weeks reported clinically meaningful improvements in pain and function, as well as a high rate of surgery avoidance [16]. These findings are consistent with our results and suggest that CIMS may contribute not only to short-term symptom relief but also to long-term functional recovery.

Mechanistically, CIMS may exert complementary effects through multiple pathways [17]. Acupuncture has been shown to modulate nociceptive ion channels and neuroinflammatory responses [18,19]. Manual therapy and exercise may enhance muscle activation and central pain inhibition, leading to improved short-term pain and disability [20,21,22,23]. Cupping therapy can improve microcirculation and lymphatic flow, thereby relieving pain related to muscle tension [24,25]. The combination of these modalities may produce synergistic effects that address both the nociceptive and functional components of DLSS. The high adherence rate and absence of significant adverse events in this study further support CIMS as a feasible adjunctive intervention.

A key distinction between the present and pilot studies is the treatment intensity and duration. Whereas the pilot utilized 12 sessions across 6 weeks, this study implemented a condensed, pragmatic 8-session, 4-week protocol. Comparable clinical trends between the two trials suggest that shorter CIMS programs may still provide meaningful benefit and may be mor feasible for routine clinical practice.

This study has several limitations. First, the single-center design may limit the external validity of the findings. Second, the 12-week follow-up period was insufficient to evaluate long-term outcomes such as symptom recurrence or delayed functional improvement. Third, single-blind design could introduce observational bias, given the impossibility of blinding participants to manual or acupuncture therapies. Finally, the individual contributions of acupuncture, cupping, and manual therapy were not evaluated independently. Future studies should explore the relative contributions of each modality and incorporate longer-term follow-up.

5. Conclusions

In patients with DLSS, adding CIMS to standard care—including SNRB and pharmacotherapy—resulted in greater reduction in pain and improvement in function outcomes over 12 weeks compared with standard care alone, extending the evidence from our earlier pilot study. No safety concerns were identified. These findings support the potential role of CIMS as an adjunctive intervention in the management of DLSS.

6. Patents

This section is not mandatory but may be added if there are patents resulting from the work reported in this manuscript.

Appendix A.1

The appendix is an optional section that can contain details and data supplemental to the main text—for example, explanations of experimental details that would disrupt the flow of the main text but nonetheless remain crucial to understanding and reproducing the research shown; figures of replicates for experiments of which representative data is shown in the main text can be added here if brief, or as Supplementary data. Mathematical proofs of results not central to the paper can be added as an appendix.

Table A1. This is a table caption.

Title 1	Title 2	Title 3
entry 1	data	data
entry 2	data	data

Table A1. This is a table caption.

Title 1	Title 2	Title 3
entry 1	data	data
entry 2	data	data