This study is a prospective, assessor-blinded, randomized controlled trial. A total of 96 participants will be recruited at the Zhejiang Provincial Hospital of Traditional Chinese Medicine. Participants will be randomly assigned to either the experimental group or the control group in a 1: 1 ratio. The trial will consist of a 4-week intervention period followed by a 6-month follow-up period. The flowchart of the research procedure is shown in
Flow chart of the study procedure.
We will recruit inpatients from the Orthopedics and Acupuncture Department (patients transferred to our department for continued treatment due to residual limb numbness after PELD surgery in Orthopedics) as well as outpatients from our hospital. Eligible individuals who agree to participate in the study will sign written informed consent. We will ensure that all participants understand they have the right to withdraw from the study at any stage, and that this will not adversely affect their future treatments. The personal information of participants will be kept confidential and managed by designated professionals on our team.
(1) Age range from 22 to 60 years old; (2) Patients with lumbar disc herniation who underwent PELD surgery and were assessed to have residual numbness symptoms on the first day after surgery; and (3) Numbness with a VAS score greater than 40 mm (score ≥ 40 mm on a 100 mm Visual Analog Scale [VAS]).
(1) Patients with a history of spinal surgery or severe spinal trauma; (2) Leg neurological symptoms unrelated to LDH, such as cervical spinal cord disease, neurological disorders, or lower extremity vascular diseases; (3) Patients with limb numbness caused by other reasons such as diabetes mellitus; (4) Patients with concurrent bone tuberculosis, tumors, and severe osteoporosis; (5) Patients with concurrent severe diseases affecting the cardiovascular, hematological, digestive, or other systems, or with mental illnesses; and (6) Patients with concurrent autoimmune diseases, allergic diseases, or acute/chronic infectious diseases.
Withdrawal criteria: (1) Individuals unable to complete the entire treatment and observation process; (2) Individuals who cannot fully understand the various forms and questionnaires provided during the study and require assistance; (3) Individuals concurrently receiving other treatments; (4) Individuals with poor compliance; (5) Individuals with incomplete data affecting efficacy and safety evaluation; (6) Individuals experiencing severe adverse reactions or complications who are unsuitable for continued treatment and are therefore withdrawn from the trial; and (7) Individuals who have not completed more than 2/3 of the treatment course (including those withdrawn from the trial and lost to follow-up).
Termination criteria: Participants experiencing severe adverse events or reactions making it inappropriate to continue in the study; major errors found in the study design or significant deviations from the facts; participants who develop serious complications or deteriorate in a condition requiring emergency measures; participants withdrawing from the clinical study; patients who are uncooperative or noncompliant with treatment, despite repeated explanations from clinicians; during the trial, researchers should retain all original trial records and document in detail the reasons and timing for withdrawal. Those who have completed more than half of the treatment regimen should be included in the efficacy statistics.
Eligible patients will be randomly assigned to two groups: the treatment group (receiving warm needle acupuncture combined with Western medicine) and the control group (receiving electro-acupuncture). The randomization will be performed using the CHISS software for block randomization. The size of each block is n. Once the randomization scheme is generated, it will be kept by a third party independent of this study. To ensure allocation concealment, we use sealed opaque envelopes. These envelopes are prepared by an independent member of the research team, and participants draw an envelope randomly upon enrollment in the study to determine their treatment group. Clinical researchers will obtain the specific treatment plan for each patient through designated channels (such as by phone). Assessors will not be informed of the participants’ specific group assignments throughout the follow-up period. All assessment work will be carried out by assessors independent of the treatment process. These assessors will receive rigorous training before the study begins to ensure their standardized understanding and application of the VAS score, thereby ensuring the consistency and accuracy of the assessments. Assessors will be strictly restricted from accessing participants’ treatment group information throughout the follow-up period to maintain assessor blinding. Blind statistical analysis will also be implemented during the data aggregation and analysis phase, with statisticians remaining unaware of the participants’ treatment allocations to ensure the objectivity of the statistical analysis results. In the event of serious adverse events, emergency medical situations, or requests from participants, the sealed envelope containing the blinding information will be opened by an independent third party, and the reasons, time, and personnel involved in the unblinding will be recorded in detail and reported to the relevant committee promptly. Medical decisions will be made based on the unblinding results, and participants will be allowed to withdraw from the trial if necessary.
The VAS score is the primary outcome measure of this trial. Based on the preliminary results from the research team’s earlier trials, the estimated VAS score for the treatment group after intervention is 1.6 ± 1 cm. Based on the data from relevant domestic clinical trials (
Participants in both groups of this study will be assessed on the first-day post-surgery, with treatment beginning on the second day and continuing for three consecutive days, totaling three sessions, with needles retained for 30 min each time. Subsequently, the treatments will be conducted three times a week for 4 weeks. Both treatments will be administered by trained acupuncturists who hold a valid practitioner certificate and have over 5 years of clinical experience, having undergone standardized training before the trial to ensure consistency. After discharge, patients need to undergo acupuncture treatment in the outpatient department; if numbness symptoms disappear, acupuncture treatment should be halted, and follow-up will continue per the experimental protocol.
Locations of acupoints.
After routine disinfection of CV 6, CV 4, the affected side’s ST 36, and GB 34, a 0.25 mm × 40 mm acupuncture needle is inserted directly, ensuring “Deqi” sensation is achieved at all acupoints. Once “Deqi” is reached, perform warm needle acupuncture at CV 6, ST 36, and GB 34; moxibustion uses moxa rolls with 1 cm lengths. During moxibustion, cardboard will be used as a shield to prevent burns.
Based on relevant literature and prior work, the electroacupuncture treatment methodology is as follows:
The location of acupoints followed the World Health Organization’s Standard Acupuncture Locations (
All patients included in this study received basic conventional Western medicine treatment: starting from the second day after surgery, they were administered anti-inflammatory and analgesic treatment (celecoxib capsules 200 mg, 1 capsule/time, 2 times/day) combined with neurotrophic treatment (mecobalamin tablets 0.5 mg, 1 tablet/time, 3 times/day) for 28 days (Note: Patients were required to continue treatment at the outpatient clinic after discharge. If their numbness symptoms disappeared, the basic Western medicine treatment was discontinued, which was recorded in the experimental protocol, and follow-up was continued according to the experimental protocol).
Drug Sources:
Mecobalamin Tablets: Produced by Jiangxi Qingfeng Pharmaceutical Co., Ltd., Approval Number: Guoyao Zhunzi H20051440.
Celecoxib Capsules: Produced by Pfizer Pharmaceutical Co., Ltd., Approval Number: Guoyao Zhunzi J20120063.
Numbness VAS Score: Patients are asked to mark their level of numbness on a 10 cm horizontal line. A higher score indicates a more severe degree of numbness. A score of 0 indicates no numbness; 1–3 indicates mild numbness that does not affect daily life; 4–6 indicates moderate numbness with a decreased quality of life but still self-care ability; 7–9 represents severe numbness with loss of self-care ability; and a score of 10 indicates intense, unbearable numbness (see
Visual analog scale for numbness.
Nylon Filament Test (10 g Monofilament Test): A 10 g monofilament is used to stroke the skin area where the patient feels numb. The numb skin area is stroked 10 times, and the number of strokes perceived is observed and recorded. Perceiving 7–10 strokes is considered normal, 1–6 strokes is considered reduced sensation, and 0 strokes is considered absent sensation. The researcher records these as 3 points, 2 points, and 1 point, respectively. The study indicates that tactile static testing using a 10 g monofilament demonstrates the highest sensitivity for detecting superficial sensory disturbances. It can be recommended as the most sensitive single testing tool (
Pinprick Test (40 g Pressure Pinprick Test): A blunt-tipped pressure needle is used to apply a constant force to the patient’s numb area. The presence or absence of pain is observed and recorded, with pain scored as 1 point and no pain scored as 0 points. The experiment differentiates neuropathic pain from sensory loss by assessing Aδ fiber function, with sensitivity and specificity ranging from 68 to 85% and 79 to 92%, respectively (
Other secondary indicators: JOA (Japanese Orthopedic Association) Score, a study mentioned that the JOA scoring system was used to evaluate 89 patients who underwent lumbar decompression surgery, and it was found that 30.3% of patients still had mild lower extremity pain/numbness and 14.6% of patients still had gait disturbances 2 years after the surgery. This indicates that the JOA scoring system can effectively identify residual symptoms after surgery (
Timeline for the collection of evaluation indicators.
| Observation indicators | Pretreatment | Treatment stage | Follow-up phase | ||
|---|---|---|---|---|---|
| Baseline (in geodetic survey) | 1 week | 4 weeks | 12 weeks after treatment | 24 weeks after treatment | |
| General information | √ | ||||
| Numbness VAS score | √ | √ | √ | √ | √ |
| Nylon rope test | √ | √ | √ | ||
| Needle punching test | √ | √ | √ | ||
| JOA score | √ | √ | √ | √ | √ |
| Lower Limb EMG | √ | √ | √ | ||
| Chinese medicine evidence score | √ | √ | √ | √ | √ |
| SF-36 (Quality of Life Scale) | √ | √ | √ | √ | √ |
| VAS score | √ | √ | √ | √ | √ |
| Safety observations | √ | √ | √ | √ | |
During the study, observations and records will be made of any potential adverse reactions, such as bleeding caused by acupuncture, hematoma, needle sickness, pain at the acupuncture site, infection, as well as skin rupture and infection after moxibustion. The primary records will include the incidence rate of adverse events and the grading of safety evaluations. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Mild (Grade 1): asymptomatic or mild symptoms, requiring no intervention; Moderate (Grade 2): symptoms are evident and require non-invasive treatment (such as local hemostasis, disinfection, etc.); Severe (Grade 3 and above): symptoms are severe, requiring hospitalization or leading to discontinuation of treatment. The evaluation time points are detailed in
After participants sign the informed consent form, researchers will collect personal information such as general demographic information, clinical history, as well as baseline data including the Numbness VAS Score, 10 g Monofilament Test, 40 g Pressure Pinprick Test, JOA Score, Lower Limb Electromyography (H-reflex difference, F-wave conduction velocity, and latency), VAS Score, Traditional Chinese Medicine Syndrome Score, SF-36 (Short Form 36 Health Survey Questionnaire), etc. Outcome measures will be assessed at specified time points and recorded in the CRF. After the trial, two researchers who are not involved in data distribution or outcome assessment will independently extract data from the CRF into an Excel table. A statistician will then perform statistical analysis on this data after careful review and confirmation. To protect participant privacy, personal names will be replaced with a combination of numbers and initials. Researchers shall keep the data confidential for 5 years after the trial termination. To reduce participant dropout rates, researchers will call participants 2 days before treatment to inquire about their condition and encourage them to receive treatment as scheduled.
A coordination management team, led by the project leader, shall be established, with dedicated trial auditors and inspectors responsible for trial management and quality control. To minimize bias in human operations, all researchers involved will undergo training. The entire research process will be supervised and inspected to ensure that all operations are carried out by standard operating procedures and that the recording and reporting of research data, treatment procedures, outcome assessments, management of investigational drugs, adverse events, etc., are filled in truthfully, accurately, and completely. Prompt measures will be taken to address any identified quality issues. The scientific research office of the project undertaking unit shall bear the responsibility for project management.
Sample size calculation was performed using PASS software (version 15.0, NCSS LLC). Based on preliminary data, the estimated mean (standard deviation) of the VAS numbness score after intervention for the treatment group (UA + WA) is 1.6 ± 1.0 cm, and for the control group (electroacupuncture) it is 2.41 ± 1.68 cm. To detect a between-group difference of 0.81 cm with 90% power (
All analyses will follow the intention-to-treat (ITT) principle, including all randomized participants. Additionally, for sensitivity analysis, a per-protocol set (PPS) analysis will be conducted, excluding participants with major protocol deviations (e.g., fewer than 8 acupuncture sessions, and use of prohibited medications). The primary outcome, the change in VAS numbness score over time points (baseline, 1 week, 4 weeks, 12 weeks, 24 weeks), will be assessed using a linear mixed-effects model (LMM). The model will include group, time, group-by-time interaction, and baseline VAS score as fixed effects. Random intercepts and slopes will account for within-individual variability. Missing data will be handled using multiple imputation (MI) with fully conditional specification (FCS) in SAS 9.4 (SAS Institute), generating 10 imputed datasets. Estimates will be combined according to Rubin’s rules. Sensitivity analysis will compare MI with the last observation carried forward (LOCF). For secondary outcomes with continuous variables (e.g., JOA, SF-36), the same LMM structure as the primary outcome will be used. For ordinal/categorical variables (e.g., TCM syndrome score), proportional odds logistic regression or generalized estimating equations (GEE) will be applied to longitudinal ordinal data. For binary outcomes (e.g., adverse events), comparisons between groups will be made using the chi-square test or Fisher’s exact test (for small sample sizes). Risk ratios (RR) and 95% confidence intervals (CI) will be reported.
The success of assessor blinding will be evaluated using James’ blinding index. A value close to 0.5 indicates effective blinding (0 = completely unblinded; 1 = completely blinded). If there are baseline differences (e.g., age, baseline VAS score), adjustments will be made using analysis of covariance (ANCOVA). Pre-specified subgroups (e.g., age < 50 vs. ≥ 50 years, baseline VAS score severity) will be explored using interaction terms in regression models.
Adverse events (AE) will be graded according to CTCAE v5.0. The incidence rates between groups will be compared using the chi-square test (or Fisher’s exact test for rare events). Descriptive analysis will be conducted for serious adverse events (≥ grade 3). Analyses will be performed using SAS 9.4 (SAS Institute) and SPSS 26.0 (IBM Corp). Continuous outcomes will be reported as mean differences (MD) with 95% CI and effect sizes (Cohen’s d). Categorical outcomes will be reported as risk ratios (RR) with 95% CI. Exact
The results of the study will be presented at scientific conferences and in peer-reviewed publications. Participants included in the study will also have the opportunity to obtain the study results by telephone or e-mail.
Currently, the protocol is version 1.0, registered on 31 August 2024. At the time of protocol submission, potential participants of the study have been actively enrolled.