Disability and Psychological Symptoms After Injection or Conservative Care for Lumbar Disc Herniation

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.

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.

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.

Plazo: 3 months after initial treatment

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.

Plazo: 3 months after initial treatment

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.

Plazo: 3 months after initial treatment

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.

Plazo: Immediately after the initial injection or initial conservative-care session

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.

Three-Month Disability and Psychological Symptom Outcomes After Image-Guided Injection Versus Continued Conservative Care for Lumbar Disc Herniation: An Exploratory Nonrandomized Cohort Study