Clinical trial NCT06024460: Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation
Official title: Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation: a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study model in this study is a pragmatic, multi-centered, randomized controlled, parallel-grouped design. This means that the study will involve multiple centers, random assignment of participants into different treatment groups (non-pharmacological treatment arm and pharmacological treatment arm), and a parallel-grouped comparison of the effectiveness of the interventions. The study aims to assess the real-world effectiveness of the treatment strategies in a pragmatic setting, allowing flexibility in treatment decisions based on clinical judgment.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study comparing non-pharmacological treatment to proactive pharmacological treatment for patient with non-acute lumbar disc herniation with moderate or higher levels of pain. The study involves 200 adult patients aged 19-69, with 50 patients from each participating hospital. Patients will be randomly assigned to either the non-pharmacological treatment group or the pharmacological treatment group 1:1 ratio. Specific interventions will be determined by doctors and Korean medicine doctors without predefined treatment strategies. The non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy and motion style acupuncture. The pharmacological treatment include medication prescription, injection, and nerve block. Treatment period is 8 weeks, and f/u for 3 years.

Detailed description: This is a pragmatic, multi-centered, randomized controlled, parallel-grouped study aiming to compare the effectiveness of a non-pharmacological treatment strategy and a active pharmacological treatment strategy in managing non-acute lumbar disc herniation with moderate or higher levels of pain persisting for more than one month in adult men and women aged 19 to 69 years.

The study will include 200 patients with lumbar disc herniation, with 50 patients from each of the participating hospitals (Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Haeundae Jaseng Hospital of Korean Medicine, competitively recruited). The patients will be assigned in a 1:1 ratio to receive either non-pharmacological treatment (100 patients) or active pharmacological treatment (100 patients) in a pragmatic randomized controlled design. The specific interventions for each group will be determined based on clinical judgment by the doctors and Korean medicine doctors involved in the study, without predefining the treatment strategies. The treatment methods, including acupuncture, electroacupuncture, spinal maunal therapy and motion style acupuncture, will be recorded in the case report form for comparative analysis.

For the non-pharmacological treatment group, patients will be recommended to receive non-pharmacological treatment based on TKM. The frequency and specifics of the treatment will be determined by the clinical judgment of the doctors and Korean medicine doctors based on the patient's symptoms, MRI images, and clinical improvement. The treatment will be conducted twice a week for a total of eight weeks, but the frequency may be adjusted according to the patient's condition. Concurrent therapies and adjuvant therapies can be freely chosen by the patients, and the details will be recorded in the case report form.

For the pharmacological treatment group, patients will be educated about proactive pharmacological treatment and recommended to receive pharmacological treatment. The specific pharmacological interventions, such as prescription medication, injection therapy, and nerve block, will be determined by the doctors based on the patient's symptoms, imaging results, and clinical judgment. The details of the prescribed medication, dosage, administration route, and duration will be recorded in the case report form. Similar to the non-pharmacological treatment group, concurrent therapies and adjuvant therapies can be chosen by the patients, and the details will be recorded.

The treatment frequency for the pharmacological treatment group will also be twice a week for a total of eight weeks, with adjustments based on the patient's condition. The effectiveness of the treatment strategies will be assessed through weekly evaluations of the patients' symptoms and treatment progress.

It should be noted that patients are not obligated to strictly follow the assigned treatment strategy, as this is a study recommending a particular treatment strategy rather than enforcing it as a protocol violation.

Eligibility criteria: Inclusion Criteria:

* aged 19 to 69 years.
* lower back pain that has persisted for at least 1 month.
* a Numeric Rating Scale (NRS) score of 5 or higher for either lower back pain or radiating leg pain over the past three consecutive days.
* confirmed lumbar disc herniation on MRI that can explain the lower back pain.
* who have provided written informed consent and agreed to participate in the clinical study.

Exclusion Criteria:

* diagnosed with specific severe diseases that could be the cause of lower back pain or leg pain (e.g., spinal metastasis, acute fractures, and spinal dislocation).
* showing progressive neurological deficits or severe neurological symptoms.
* with pain originating from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
* with other chronic conditions (e.g., stroke and myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy) that may interfere with the treatment effect or result interpretation.
* taking steroids, immunosuppressive drugs, psychiatric medications, or other medications that may impact the study results.
* acupuncture or nerve block treatment is inappropriate or unsafe, such as those with a history of bleeding disorders, receiving anticoagulant therapy, or diagnosed with uncontrolled diabetes.
* taken non-steroidal anti-inflammatory drugs (NSAIDs) or other pain-affecting drugs or received acupuncture treatment within the past 5 days.
* Pregnant women, those planning pregnancy, or breastfeeding women.
* within 3 months after lumbar surgery.
* who have not completed participation in another clinical study within the past month or have plans to participate in another clinical study within 6 months from the selection date or during the study participation and follow-up period.

Inability to provide written informed consent.

- Other cases where the researchers determine that participation in the clinical study would be difficult.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Numeric Rating Scale for Pain of Dominant Change (NRS for DC)
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary outcomes:
measure: Recurrence
timeFrame: Week 13, 26, 39, 52, Month 18, 24, 36
measure: Numeric Rating Scale (NRS) for Low Back Pain
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Credibility and Expectancy
timeFrame: Baseline
measure: Intention to Treat
timeFrame: Week 9
measure: Work Productivity and Activity Impairment-Specific Health Problem
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
measure: Classification of Disc Degeneration
timeFrame: Week 1, 26, 52, Month 24, 36
measure: Stages to a Disc Herniation
timeFrame: Week 1, 26, 52, Month 24, 36
measure: Herniated Disc Areas
timeFrame: Week 1, 26, 52, Month 24, 36
measure: Cost Data Survey
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, Dr
role: STUDY_DIRECTOR
References: