An observational study in Lumbar Disc Herniation and Lumbar Radiculopathy, sponsored by Hebei Medical University Third Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hebei Medical University Third Hospital · Observational
Lumbar disc herniation can cause leg pain, difficulty with daily activities, and symptoms of depression or anxiety. This completed study compared disability and psychological symptom scores in patients who chose an image-guided injection with those who continued conservative care. Sixty-four patients at Tiemenguan People's Hospital were included in the analytical cohort, with 32 in each group. Treatment was chosen through patient preference and discussion with clinicians. Disability, depressive symptoms, and anxiety symptoms were assessed before treatment and at a nominal three-month follow-up. Pain was recorded before and immediately after the first treatment session. The study examined whether the two treatment groups had different three-month scores. The comparison is observational and cannot establish that treatment caused the differences. This record is prepared after data collection; outcome ordering was determined after data collection.
This was an exploratory, single-center, prospective, nonrandomized observational cohort at Tiemenguan People's Hospital, Tiemenguan, Xinjiang, China. The manuscript reports a study period from January 2021 to August 2024. Participants had single-level lumbar disc herniation with corresponding unilateral radicular symptoms, persistent symptoms despite at least three months of conservative treatment, and baseline PHQ-9 and GAD-7 scores of 5 to 14 each.
Treatment selection followed patient preference and shared decision-making rather than protocol-assigned allocation. The initial exposures were a fluoroscopy-guided periradicular/epidural injection package using reverse geometric planning, lidocaine, and compound betamethasone, or continued conservative care with celecoxib, infrared physical therapy, and home rehabilitation guidance. Subsequent adherence, treatment crossover, rescue analgesia, and other care were not quantified.
The analytical cohort comprised 64 unique patients with paired baseline and nominal three-month disability and psychological symptom scores. The screening denominator, individual exclusion counts, and attrition before inclusion in this dataset were unavailable. The source sampling procedure was not sufficiently documented to establish random or consecutive sampling. Three-month outcome assessors were blinded to treatment group; patients and treating clinicians were not blinded.
The principal analysis compared three-month ODI, PHQ-9, and GAD-7 totals using separate linear models adjusted for the corresponding baseline score, age, and sex. HC3 robust standard errors and Holm correction across the three outcomes were used. Immediate VAS pain scores and injection procedural records were descriptive. Threshold-response and pain-psychological-change association analyses were exploratory.
This completed study is being registered after data collection. A prospectively dated protocol and analysis plan were unavailable. Outcome ordering and statistical specifications were defined after data collection. ODI is placed in the primary-outcome field and PHQ-9 and GAD-7 in secondary-outcome fields to describe the manuscript's post hoc ordering, without implying prospective prespecification. Follow-up was nominally three months; exact assessment dates and a verified visit window were unavailable. Pain was not measured at three months. Structured adverse-event surveillance was unavailable, so adverse-event rates and comparative safety were not estimated.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 117 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Hebei Medical University Third Hospital is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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Patients with MRI-confirmed single-level lumbar disc herniation and corresponding unilateral radicular symptoms treated at Tiemenguan People's Hospital, Tiemenguan, Xinjiang, China. The analytical cohort included 64 patients who selected injection or continued conservative care. The full screened population was not reported.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with lumbar disc herniation who selected a fluoroscopy-guided periradicular/epidural injection package using reverse geometric planning, lidocaine, and compound betamethasone through shared decision-making. The analytical cohort included 32 patients in this group.
Procedure: Fluoroscopy-guided periradicular/epidural injection with reverse geometric planning · Drug: Lidocaine · Drug: Compound betamethasone
Patients with lumbar disc herniation who selected continued conservative care through shared decision-making. Initial care comprised celecoxib, local infrared physical therapy, and subsequent home rehabilitation guidance. The analytical cohort included 32 patients in this group.
Drug: Celecoxib · Other: Infrared physical therapy · Behavioral: Home rehabilitation guidance
Anteroposterior and lateral fluoroscopy were used for surface projection and trajectory planning. A 22-gauge spinal needle was advanced toward the affected periradicular/epidural target under intermittent fluoroscopy and contrast observation. Iohexol 300 mg iodine/mL, 0.5 to 1.3 mL, was used to assess contrast spread before therapeutic injection.
One mL of 1% lidocaine, equivalent to 10 mg, was included in the 2 mL therapeutic injectate. Local infiltration with 1% lidocaine preceded needle advancement; its volume was not recorded in the analytical dataset.
Drug pages: Betamethasone sodium phosphate · Betamethasone dipropionate
One mL of compound betamethasone was included in the therapeutic injectate, containing 5 mg betamethasone as dipropionate and 2 mg betamethasone as sodium phosphate, totaling 7 mg betamethasone equivalents according to the product label.
Celecoxib 200 mg orally once daily was prescribed as part of initial conservative care. The duration of subsequent medication use and actual adherence during follow-up were not quantified.
Local infrared physical therapy was prescribed once daily for two weeks.
Home rehabilitation guidance followed initial conservative care. Exercise dose and actual rehabilitation adherence were not quantified.
Oswestry Disability Index score at 3 months
Total Oswestry Disability Index (ODI) score at the nominal three-month follow-up, recorded as a percentage from 0 to 100; higher scores indicate greater disability. The registered metric is the absolute three-month total score. Baseline ODI was recorded for adjustment. Only final percentages were retained; item-level scores and the original scoring denominator were unavailable. The primary-outcome designation was assigned after data collection.
Time frame: 3 months after initial treatment
Patient Health Questionnaire-9 score at 3 months
Total Patient Health Questionnaire-9 (PHQ-9) score at the nominal three-month follow-up, ranging from 0 to 27; higher scores indicate greater depressive symptom burden. The registered metric is the absolute three-month total score. Baseline PHQ-9 was recorded for adjustment. Total scores do not establish a psychiatric diagnosis or remission. The secondary-outcome designation was assigned after data collection.
Time frame: 3 months after initial treatment
Generalized Anxiety Disorder-7 score at 3 months
Total Generalized Anxiety Disorder-7 (GAD-7) score at the nominal three-month follow-up, ranging from 0 to 21; higher scores indicate greater anxiety symptom burden. The registered metric is the absolute three-month total score. Baseline GAD-7 was recorded for adjustment. Total scores do not establish a psychiatric diagnosis or remission. The secondary-outcome designation was assigned after data collection.
Time frame: 3 months after initial treatment
Immediate visual analog scale pain score
Self-rated pain score on a 0 to 10 visual analog scale (VAS), with 0 indicating no pain and 10 the worst pain imaginable. The registered metric is the absolute immediate post-treatment total score. Pretreatment pain was also recorded as a reference. Immediate ratings followed the injection or the first conservative-care session and were descriptive. Exact elapsed minutes were unavailable. Pain was not measured at three months.
Time frame: Immediately after the initial injection or initial conservative-care session
Plan to share: Yes
Supporting information: Analytic code
Time frame: Beginning immediately following article publication and ending 5 years following article publication.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement →
Hebei Medical University Third Hospital